Research

Funding
NIH HEAL Initiative

Principal Investigator
Gerald Cochran, MSW, PhD (University of Utah School of Medicine); T. John Winhusen, PhD (University of Cincinnati, Addiction Sciences Division)

Project Summary
The primary objective of this study is to evaluate the criterion and concurrent validity of the Narcotic Score (NS metric) as a clinical measure of opioid misuse and use disorder and establish risk level thresholds within community pharmacies - an optimal - yet underutilized setting for identification and engagement of patients with opioid risk.

Funding
NIH HEAL Initiative

Principal Investigator
Laura-Mae Baldwin, MD, MPH (University of Washington)

Project Summary
This project seeks to develop and test a “train the trainer” curriculum and training experience that will facilitate the spread and use of the Six Building Blocks (6BBs) by adapting the 6BBs framework and toolkit for health systems and other organizations, training personnel to facilitate its implementation, and monitoring results of this implementation.

Funding
NIH HEAL Initiative

Principal Investigator

Kathleen T. Brady, M.D., Ph.D. (Medical University of South Carolina); Karen Hartwell, M.D. (Medical University of South Carolina)

Project Summary
This proposal would address barriers to the NP’s ability to prescribe buprenorphine by incorporating waiver education into NP final semester curriculum.  The initial eight hours of training would be provided to students in a face to face classroom setting or via live video streaming.  The remaining 16 hours would be completed by the NP students through online modules offered by the AANP.  Trained NP students would be eligible for one year of peer to peer mentorship and inclusion in the MUSC Project ECHO tele-mentoring for new providers.  Outcomes to be tracked would be the number of NP’s trained who obtain their waiver and the number of individuals treated with MAT by the NP’s trained.  Secondary data collected would offer insight into wavier obtainment process and determine need for mentorship for newly waivered providers.

Funding
NIH Heal Initiative

Principal Investigator
Adam J. Gordon, MD, MPH, FACP, DFASAM, CMRO (University of Utah Health)

Project Summary
This study will include analyses of VA databases to examine patient and organizational characteristics associated with buprenorphine termination during outpatient treatment for opioid use disorder.  These analyses are critical for generating data and forming further hypotheses on how to implement targeted approaches to improve retention in treatment.

Funding
NIH Heal Initiative

Principal Investigator
Dan Hartung, PharmD, MPH (Oregon State University/Oregon Health and Science University)

Project Summary
This study will use a multi-state linked administrative database to compare opioid-related outcomes among Medicaid recipients admitted for treatment of opioid use disorder in outpatient and inpatient (or residential) facilities.  Patient and organizational factors predicting higher retention in outpatient treatment for OUD will also be examined.  These data will be used to generate hypotheses on how to improve retention in treatment.

Funding
NIH Heal Initative

Principal Investigator
Keith Humphreys, PhD (Stanford University School of Medicine)

Project Summary
Using a meta-analytic approach retrospectively analyzing data of individuals with drug use disorders, determine the impact of drug-focused 12-step mutual help groups, free of selection bias, in reducing opioid consumption and opioid-related problems.  These data will be used to generate hypotheses on how the augmentation of 12-step mutual help groups, added to medication-assisted treatments (MAT), may be used to improve retention in treatment.

Funding
NIH Heal Initiative

Principal Investigator(
Cynthia Campbell, PhD (Kaiser Permanente)

Project Summary
The goal of the proposed study is to expand the prescription opioid registry developed in study CTN 0061, across diverse health systems with harmonized EHR data, and leverage it to answer several key ‘next step’ research questions in response to the opioid crisis.  We propose to adapt and expand the registry to 8 other health systems across the nation, initially within the Health System Node (HSN) to maximize efficiency in the short study timeframe, but with potential to be expanded to other nodes in the future.

Funding
NIDA CTN

Principal Investigator
Jeffrey D. Klausner, MD, MPH (University of California, Los Angeles)

Project Summary
The risk of HIV infection is magnified for men who have sex with men (MSM), especially minority MSM < 30 years of age and with substance use problems.  A promising approach to HIV prevention among this high-risk population is the targeted promotion of HIV self-testing, simplified access to test kits and seamless linkage to pre-exposure prophylaxis (PrEP) medication.  This project seeks to compare the relative effectiveness of using social media sites versus informational sites like to promote HIV self-testing and PrEP uptake.  MSM between 18-30 years old will receive culturally-relevant advertisements targeting minorities similar to those previously developed.  Specifically, the study aims to 1) adapt existing social media-based HIV self-testing and PrEP advertising materials for digital distribution on social media and informational sites and 2) compare the effectiveness of HIV testing and PrEP uptake promotion across social media sites versus online informational platforms.

Funding
NIDA CTN

Principal Investigator
Susan Tross, PhD (Columbia University); Mary Hatch-Mailette, PhD (University of Washington)

Project Summary
While HIV incidence in the broader population in the US decreased by 18%, between 2008 and 2014, among men who have sex with men (MSM), it increased by 6%.  Pre-exposure prophylaxis (PrEP) is at the cutting edge of HIV prevention worldwide, yet widespread use and promotion of PrEP has not been widely adopted.  Also, despite of current evidence on efficacy of Naloxone and MAT interventions to prevent opioid overdose and treat opioid use disorders (OUD), appropriate models to implement in MSM-Centered CBOs are yet to be identified.  Information (e.g. access, readiness, capacity, barriers, resource gaps, etc.) is needed to assist in the effort to increase awareness and use of PrEP and adoption of OUD interventions.  The study aims to identify health department STI clinics and and/or HIV- centered community-based organizations delivering services to assess: 1) program directors’ and providers’ knowledge/awareness of, interest in, perceived challenges/facilitators to and strategies for, offering PrEP and OUD interventions 2) and MSM’s knowledge/awareness of, interest in, perceived challenges/facilitators to and recommended strategies for, being offered PrEP and OUD interventions.

Funding

NIDA CTN

NOTE: This project is supported in a collaboration with the DHHS Office of the Assistant Secretary for Planning and Evaluation using resources from the Patient Centered Outcomes Research Trust Fund (Interagency Agreement #ASPE-2018-001).

Principal Investigator

Arjun Krishna Venkatesh, MD, MBA, MHS (Yale School of Medicine); Kathryn Hawk, MD, MHS (Yale School of Medicine); Richard Andrew Taylor, MD, MHS (Yale School of Medicine)

Project Summary

The goal of the project is to build clinical data research infrastructure that will begin to enhance capacity to use electronic health record (EHR) data and patient-reported outcomes measures (PROs) to conduct pain and opioid related research in Emergency Departments (EDs). Existing and potential common data elements (CDE) in emergency medicine settings relevant to opioid misuse and use disorders will be identified. Validity and feasibility testing will be conducted to compare opioid relevant CDEs electronically extracted from participating EDs by the American College of Emergency Physicians (ACEP) Clinical Emergency Data Registry (CEDR) to assess how consistently data elements are obtained in CEDR, the degree to which data elements are captured with a standard format, and whether data elements are easily mapped from various EHR systems to the CEDR. The feasibility and acceptability of electronically collecting patient reported outcome measures via patient portals will be examined.

Funding
NIDA Clinical Trials Network (NIH HEAL Initiative)

Project Period
9/01/2017-5/31/2019

Principal Investigators
Ryan McCormack, MD, MS (NYU Langone Health); John Rotrosen, MD (Co-Lead Investigator); Kathryn Hawk, MD, MHS (Co-Investigator); Lisa Marsch, PhD (Northeast Node, Node PI); Gail D’Onofrio MD (Co-Investigator)

Site
Catholic Medical Center

Site Principal Investigator
Jeremy Arnold, MD

Other Project Staff
Phoebe Gauthier MA, MPH (National Project Manager); Patricia Novo, MPA, MPH (Co-National Project Manager); Sarah Farkas, MA (Lead Regulatory); Dee Blumberg PhD (CCC Project Manager); Dagmar Salazar, MS (CCC Protocol Specialist); Radhika Kondapaka MBBS, RAC (CCC Safety Monitor); Eve Jelstrom, MBA, CRNA (CCC Project Director); Robert Lindblad MD (CCC Medical Monitor); Tracy Dalrymple, MS (DSC Data Manager); Caroline Mulatya PhD (DSC Statistician); Lauren Yesko (DSC Project Director); David Liu, MD (CCTN Protocol Liaison); Kristen Huntley, PhD (CCTN Protocol Liasion); Andrea Meier, MS, LADC, LCMHC (Northeast Node); Bethany McLeman, BA (Northeast Node)

Project Summary
Our central research question is: In settings with high need, limited resources, and differing staffing structures for managing opioid use disorder (OUD), what is the feasibility and impact of introducing a clinical protocol for OUD screening and buprenorphine (BUP, either as sublingual [SL-BUP] or extended-release [XR-BUP]) treatment initiation in the Emergency Department (ED) with referral for treatment?

Aims:
1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30.

This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. We will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. We will employ a participatory action research approach and use mixed methods incorporating data derived from:
1. Medical record and administrative data abstraction,
2. Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
3. Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.

Public Health Relevance
The opioid epidemic has a large and growing impact on public health, and continues to decimate communities ill equipped to provide substantive, timely intervention. By assembling subject matter experts and involving local stakeholders, we will translate successful elements of efficacious interventions to EDs operating in different contexts. These partnerships provide an opportunity for prompt, meaningful and sustainable dissemination with enhanced support for the intervention while it is being developed and tested in situ. This study is designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs where this intervention is most needed – which, if successfully done, should save lives, improve outcomes, and reduce costs to society.

Funding
NIDA CTN

Principal Investigator
Sandra Radin, Ph.D. (University of Washington)

Project Summary
This study, in partnership with two American Indian tribes in the Pacific Northwest, addresses critical barriers in the implementation of medication assisted treatment (MAT) for opioid use disorder (OUD).  MAT approaches have been shown to substantially improve outcomes for OUD patients, yet provider and patient biases against MAT and organizational barriers to MAT use are widespread, particularly within tribal communities where there is a strong preference toward total abstinence as a goal.  The study aim is to identify knowledge and perceptions of MAT approaches and barriers/facilitators for implementation and sustained use.  Study results will inform future clinical efforts to tailor MAT for high need, low resource American Indian/Alaska Native (AIAN) populations.

Funding
NIDA CTN

Principal Investigator
Gwen Lapham, PhD, MPH (Group Health Research Institute); Katharine Bradley, MD, MPH (Group Health Reseach Institute)

Project Summary
Medical Cannabis Use among Primary Care Patients: Using Electronic Health Records to Study Large Populations.  The objective of the proposed rapid response research, in a state with legal medical and nonmedical cannabis use, is to better understand medical use of cannabis in a single large health system that routinely asks primary care patients about the frequency of past-year cannabis use.  Specific Aims are to: 1) Develop and validate a natural language processing (NLP) algorithm to identify electronic health record (EHR)-documented medical cannabis use, 2) Describe patients with EHR-documented medical cannabis use and compare them to patients with other types of cannabis use, and 3) Describe patient experience of medical cannabis use among patients with EHR-documentation of its use.

Funding
NIDA CTN

Principal Investigators
Gavin Bart, MD, PhD (Northstar Node, Minneapolis Medical Research Foundation Hennepin County Medical Center); Rebecca Rossom, MD, MS (Northstar Node, HealthPartners Institute for Education & Research)

Project Summary
The primary objective of this 2 year pilot study is to program opioid use disorder (OUD) clinical decision support (CDS) for use in an electronic medical record (EMR). The secondary objectives of this pilot study are to: 1) evaluate feasibility, usability, and acceptability with buprenorphine prescribing primary care providers during a 6-month pilot phase and 2) assess changes in readiness to identify and manage OUD, provider satisfaction with OUD CDS, and usage.

Funding

NIDA CTN

Principal Investigator

Li-Tzy Wu, ScD, RN (Duke Clinical Research Institute)

Project Summary

A collaborative care model for people with opioid use disorder that involves buprenorphine-waivered physicians and community pharmacists appears to be feasible to operate in the United States and have high acceptability to patients. A high proportion (93.4%, 71/76) of eligible participants enrolled into the study. There were high rates of treatment retention (88.7%) and adherence (95.3%) at the end of the study. The proportion of opioid-positive urine drug screens (UDSs) among complete cases (i.e. those with all six UDSs collected during 6 months) at month 6 was (4.9%, 3/61). Intervention fidelity was excellent. Pharmacists used PDMP at 96.8% of visits. There were no opioid-related safety events. Over 90% of patients endorsed that they were "very satisfied with their experience and the quality of treatment offered," that "treatment transfer from physician's office to the pharmacy was not difficult at all," and that "holding buprenorphine visits at the same place the medication is dispensed was very or extremely useful/convenient." Similarly, positive ratings of satisfaction were found among physicians/pharmacists.

Funding

NIDA CTN

Principal Investigator

Katharine Bradley, MD, MPH (Kaiser Permanente Washington Health Research Institute)

Project Summary

Though treatment for opioid use disorders with medications (buprenorphine or naltrexone provided in primary care, or methadone from an Opioid Treatment Program) has been shown to be effective, the majority of patients with OUDs are never treated with medications, and most primary care practices do not offer buprenorphine treatment. This trial seeks to compare a collaborative care model to usual primary care for management of OUDs in primary care across multiple health care systems.

Funding

NIH Heal Initiative

Principal Investigator

Katharine Bradley, MD, MPH (Kaiser Permanente Washington Health Research Institute); Sean Murphy, PhD (Weill Cornell Medicine)

Project Summary

Effective treatment for opioid use disorder (OUD) has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial's results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other healthcare stakeholders. The study wille valuate the economic viability of the PROUD collaborative care model for OUD; that is, from the perspective of the health care sector, to what extent do the downstream cost savings associatd with improved patient outcomes offset the additional costs of the PROUD intervention. The specific aims are to: 1) estimate the start-up and ongoing management costs of the PROUD intervention; 2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUD prior to clinic randomization; 3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit-incremental cost), from the health care sector perspective.

Funding 
NIDA CTN

Project Period
6/1/16-5/31/19

Principal Investigators
Lisa A. Marsch, PhD (Geisel School of Medicine at Dartmouth); Santosh Kumar, PhD (University of Memphis)

Site
Johns Hopkins University

Site Principal Investigator
August Holtyn, PhD

Other Project Staff
Dr. Emre Ertin (sensor expert who designed AutoSense and EasySense sensors at Ohio State); Dr. Kenzie Preston (Chief of the Clinical Pharmacology and Therapeutics Research Branch at the NIDA Intramural Research Center); Dr. August Holtyn (Research Associate at the Center for Learning and Health at the Johns Hopkins University School of Medicine); Dr. Udi Ghitza (CCTN); Dr. Dee Blumberg (CCC); Jennifer McCormack (DSC); Shahin Samiei (University of Memphis); Andrea Meier (Dartmouth); Bethany McLeman (Dartmouth); Samantha Auty (Dartmouth);Carmen Rosa (CCTN); Syed Hossain (University of Memphis); Massoud Vahabzadeh (Chief of the Biomedical Informatics Section at the NIDA Intramural Research Center); Jia-Ling Lin (Biomedical Informatics Section at the NIDA Intramural Research Center); Mustafa Mezghanni (Biomedical Informatics Section at the NIDA Intramural Research Center)

Project Summary
The goal of this project is to investigate methods to detect cocaine use from heart rate data captured by smartwatches, so this approach can be deployed widely in the NIDA Clinical Trials Network (CTN). This method will enable us to automatically detect cocaine use and the precise timing of such use. And, this approach can nicely complement self-report methods that suffer from temporal inaccuracy in reporting cocaine use in the field setting. Detection of cocaine use via smartwatches will build upon, and extend, our recently developed methods to identify cocaine use from interbeat interval heart rate data obtained from electrocardiogram (ECG) sensors and physical activity from accelerometer data.

The specific aims of the project are:

1.Develop a smartwatch device that can reliably detect interbeat interval and can last the entire day on a single charge of battery with continuous sensor data collection.

2.Conduct a user study to determine the feasibility of using smartwatches to collect reliable interbeat interval and physical activity data in the natural field setting. This study will provide the data necessary to determine under what conditions high quality data can be obtained from smartwatches, identify common failure scenarios, and understand wearability/usage patterns.

3.Adapt the computational model for detecting cocaine use from interbeat interval, so it can be applied to the interbeat and physical activity data obtained from smartwatches. We will also assess the degree of specificity of the model relative to other stimulant use.

Public Health Relevance
Illicit drug use results in significant consequences including morbidity, mortality and health care costs. Detection of cocaine use relies heavily on inaccurate self-report or intrusive urine screens. Detection by smart watches offer many benefits to researchers, providers and consumers.

Funding
NIDA CTN

Principal Investigators
Constance Weisner, DrPH, MSW (Health Systems Node, University of California, San Francisco; Kaiser Permanente)

Project Summary
This study will examine how performance on the AOD initiation and engagement measures vary by characteristics of the eligible population; how performance on the AOD initiation and engagement measures vary by system characteristics; and structural differences and policies within each region and for specific facilities which may explain variations in performance on the HEDIS AOD Initiation and Engagement measures.

Funding
NIDA CTN

Principal Investigator
Li-Tzy Wu, ScD, RN (Mid Southern Node, Duke Clinical Research Institute)

Project Summary
The immediate purpose of this work is to identify electronic health record (EHR) data available today and in the near future at healthcare facilities participating in the NIDA Clinical Trials Network (CTN). The overarching goal is to address a critical barrier to progress in substance use disorder (SUD) research and support planning on the CTN for research infrastructure to leverage EHR data for research informing SUD screening, intervention, treatment, and referral efforts.

Funding
NIDA CTN

Principal Investigator
Gavin Bart, MD, PhD, FACP, FASAM (Northstar Node, Minneapolis Medical Research Foundation, Hennepin County Medical Center)

Project Summary
The research project will explore institutional variability in the interpretation and implementation of 42 CFR Part 2 regulations related to health systems data privacy practices, policies and information technology architecture. Specific aims include describing the range of interpretations of 42 CFR Part 2 across health systems participating in the Clinical Trials Network and describing the range of current information technology implementation practices for 42 CFR Part 2 regulations (e.g., EHR operationalization; workflow strategies; workarounds).

Funding
NIDA CTN

Principal Investigator
Gail D'Onofrio, M.D., M.S. (Yale University School of Medicine)

Project Summary
The study uses a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design.  The study will be conducted at four EDs with a high prevalence of patients with untreated opioid use disorder (OUD).  The four sites will receive the same sequence of evaluations and interventions: the baseline evaluation period after the standard dissemination practice, the IF phase, and continuation of facilitation into the IF evaluation period.  The timing of initiation of the study activities at each site will be randomly offset by ~ 3 month increments to accommodate logistical constraints of simultaneous implementation at all sites.  The study populations will include (1) ED providers and staff involved in the treatment of patients with OUD; (2) Community opioid treatment provider and program staff involved in providing care for patients with OUD referred from the ED; and (3) ED patients with moderate to severe OUD.

Funding
NIDA CTN

Principal Investigator
Madhukar Trivedi, MD (University of Texas Southwestern Medical Center)

Project Summary
This study, building on the lessons learned from the ADAPT Study; will further investigate the effectiveness and safety of a combination pharmacotherapy (XR-NTX; as Vivitrol® plus once-daily bupropion extended-release tablets) for methamphetamine use disorder.

Funding
NIDA CTN

Principal Investigator
Todd Korthuis, MD, MPH (Oregon Health & Science University)

Project Summary
This study will build on lessons learned from the CHOICES pilot study (CTN-0055) and to advance understanding of XR-NTX adoption in HIV primary care settings.  HIV primary care clinics are being selected to participate in an open-label trial of office-based XR-NTX in HIV-infected participants with untreated opioid use disorder or alcohol use disorders.

Funding
NIDA CTN

Principal Investigator
Yih-Ing Hser, Ph.D. (Western States Node, Integrated Substance Abuse Programs, UCLA)

Project Summary
Opioid addiction is associated with excess mortality, morbidities, and other adverse health and social conditions. Most knowledge of opioid addiction, however, is based on studies of individuals treated in publicly-funded specialty programs. At present there is limited information about patterns of opioid use, related infectious disease (HIV, hepatitis C), and other co-morbidity, and health care utilization among individuals treated in primary care settings. The availability of electronic health records (EHRs) provides the opportunity to examine the health status and service use among large and diverse primary care samples. This study will analyze electronic health records of individuals treated for opioid addiction in a primary care network and will link EHR data with two other existing data systems (i.e., Prescription Drug Monitoring Program or PDMP, National Death Index) in order to generate actionable knowledge and identify ways to improve care.

Funding
NIDA CTN

Principal Investigator
Katharine Bradley, MD, MPH (Health Systems Node, Group Health Research Institute)

Project Summary
Recent trials of screening and brief intervention for drug use have no demonstrated benefit compared to screening alone. However, the value of screening for drug use, compared to no screening, has not been evaluated. Screening for drug use may identify patients with drug use disorders who might need more intensive treatments than brief intervention. In states where marijuana use is now legal for recreation, as well as medical uses, clinicians want to be aware of and assess risks of marijuana use. Further, little is known about the predictive validity of screens for marijuana and/or drug use/misuse for subsequent adverse health outcomes. To that end, this study seeks to evaluate implementation of drug screening in primary care to: 1) describe rates of drug and marijuana screening, and positive screens, as well as barriers and facilitators to population-based screening; 2) assess changes in rates of assessment and identification; and 3) assess whether drug and marijuana use is associated with increased subsequent urgent care, ED, and hospitalization.

Funding
NIDA CTN

Principal Investigator
Lisa R. Metsch, PhD (Florida Node Alliance, University of Miami Miller School of Medicine)

Project Summary
Using the existing CTN-0049 cohort as a research platform, the proposed RCT will assess the effectiveness of an efficacious linkage to care intervention for HIV/HCV co-infected substance users. Linkage to care will be operationalized as receipt of clinical evaluation/treatment for HCV infection. Secondary objectives will be to assess: 1) relative success at each step in the cascade, 2) engagement in substance use treatment and HIV care, and 3) HIV viral suppression as well as 4) to examine other long-run outcomes of the CTN-0049 cohort.

Funding
NIDA CTN

Principal Investigator
Lisa R. Metsch, PhD (Florida Node Alliance, University of Miami Miller School of Medicine)

Project Summary
This study seeks to determine: 1) if the primary and secondary causes of death among CTN-0049/64 participants were due to AIDS, liver disease, substance use, or non-AIDS comorbidities, 2) if there are differences in primary and secnodary causes of death among those with and without hepatitis C. Furthermore, the study aims to determine risk factors for all-cause mortality based on baseline CTN-0049/64 data and follow-up health services data. An HIV-specific mortality index will be developed to help clinicians and public health officials determine who is at the highest risk for mortality in three years.

Funding
NIDA CTN

Principal Investigator
Jennifer McNeely, MD, MS (NYU Grossman School of Medicine)

Project Summary
This is a phased feasibility and proof-of-concept study seeking to incorporate addiction-specific screening and assessment CDEs into a widely used EHR, explore the logistics and time required to do this, and assess impacts on the frequency of identification, diagnosis and referral to treatment in large healthcare organizations.

Funding

NIDA CTN

Principal Investigator

Jennifer McNeely, MD, MS (NYU Grossman School of Medicine)

Project Summary

This ancillary study is related to CTN-0062-Ot, "A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements into the Electronic Health Record in Large Primary Care Settings (CDE-EHR-PC)."

This study aims to: 1) program the TAPS Tool and decision support into the health system's electronic health record (EHR), 2) study the process of implementation of screening and referral using EHR-driven CDEs and clinical decision support in three federally qualified health center primary care clinics, and 3) evaluate the impact of implementation on patient, provider, and systems level outcomes.

Funding
NIDA CTN

Principal Investigator
Cynthia Campbell, PhD (Health Systems Node, Kaiser Permanente)

Project Summary
Analyzing data stored in Kaiser Permanente Northern California’s Virtual Data Warehouse, this study will assess adult new and long-term prescription opioid users in a large integrated health care delivery system to identify treatment patterns, risk factors, and associated outcomes over ti

Funding

NIDA CTN

Principal Investigator

Sharon Levy, MD, MPH (Harvard Medical School)

Project Summary

This study seeks to test the psychometric properties of three instruments, BSTAD, S2BI, and TAPS, against a criterion standard of DSM-5 substance use disorder diagnoses in a population of adolescents presenting for routine primary care.

Funding
NIDA CTN

Principal Investigators
Robert P. Schwartz, MD (Mid Atlantic Node, Friends Research Institute, Inc.); Li-Tzy Wu, ScD, RN (Mid Southern Node, Duke Clinical Research Institute); Jennifer McNeely, MD (Greater New York Node, New York University)

Project Summary
This study seeks the validation of a clinically useful brief screening and assessment instrument to identify patients with problematic substance use or a substance use disorder to facilitate brief interventions and referrals to appropriate treatment. Specifically, this study's aims are to 1) develop a two-stage brief screening and assessment instrument to detect unhealthy use of tobacco, alcohol, prescription, and illicit drugs among primary care patients; 2) examine the validity of this 2-state instrument by comparing it to reference standard measures for substance use, problematic use, and substance use disorders; and 3) determine the feasibility of a self-administered 2-stage tool and an interviewer-administered 2-stage tool in US general medical set

Funding
NIDA CTN

Principal Investigator
Li-Tzy Wu, ScD (Mid Southern Node, Duke Clinical Research Institute)

Project Summary
This study leverages the existing research resources of a funded parent project “Duke University Centers for Medicare and Medicaid Services (CMS) Innovation Award Southeastern Diabetes initiative (PI: Robert M. Califf, MD).” It explores the feasibility of implementing Screening for substance use, Brief Intervention, and Referral to Treatment services (SBIRT) in diabetic patients in primary care, and examines the effects of substance use status on diabetes health care outcomes. It also assesses the feasibility of the CTN’s clinical decision support algorithm for SBIRT in the primary care setting. This project uses a longitudinal, community-based design nested within the parent study in a diabetes care setting. Adults aged 18 or older with type 2 diabetes and who meet the inclusion and exclusion criteria for the parent study at the Durham County, North Carolina sites will be screened and assessed for substance use at baseline and 6, 12, 18 and 24-month follow-up periods. The study will examine changes in substance use trajectories and explore the impact of substance use status on subsequent diabetes care and health outcomes.

Funding
NIDA CTN

Principal Investigator
Walter Ling, MD (Integrated Substance Abuse Programs, UCLA) Zunyou Wu, MD, PhD (China Center for Diseases Control and Prevention)

Project Summary
The high proportions of patients lost at each step along the continuum of HIV care result in suboptimal benefits of life-saving antiretroviral therapy (ART) in developing countries. This project examined the effects of a hospital-based structural intervention (One4All) designed to ensure that HIV-positive individuals receive a confirmed HIV diagnosis and determination of treatment eligibility. The primary aim was to determine whether implementation of the One4All intervention increases the proportion of HIV-positive, treatment-eligible patients who are identified and linked to ART and who achieve VL suppression, thereby reducing mortality.

Funding
NIDA CTN

Principal Investigator
Todd Korthuis, MD, MPH (Western States Node, Oregon Health and Science University)

Project Summary
HIV-infected patients receiving office-based treatment are more likely to achieve HIV viral suppression, decreasing the overall community viral load and associated HIV incidence. Injection drug users are least likely to engage in HIV care and achieve HIV viral suppression compared to other HIV risk groups. Substance abuse treatment can increase engagement in HIV care, but HIV providers have limited options for long-acting office-based addiction treatments. This study will compare extended-release naltrexone to treatment as usual for opioid dependence in approximately 400 HIV-infected patients.

Funding
NIDA CTN

Principal Investigator
Walter Ling, MD ( Integrated Substance Abuse Programs, UCLA); Larissa Mooney, MD (Integrated Substance Abuse Programs, UCLA)

Project Summary
The aim of this 2-stage, 3-site study is to investigate the safety and effectiveness of depot naltrexone (XR-NTX; as Vivitrol®) plus extended-release bupropion (BRP; as Wellbutrin XL®) for methamphetamine use disorder. Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type). Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of depot naltrexone plus once-daily bupropion extended-release tablets for 8 weeks. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and follow-up visit during Week 9. If Stage 1 data document success in at least 3 "responder” study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder” success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.

Funding
NIDA CTN

Principal Investigator
Kevin Gray, MD (Southern Consortium; Medical University of South Carolina)

Project Summary
This is a 12-week, intent-to-treat, randomized controlled trial to evaluate the impact of N-Acetylcysteine (NAC) 1200 mg versus matched placebo (PBO) twice daily, added to compliance enhancement (CE) and contingency management (CM) interventions, on cannabis use among treatment-seeking adults (ages 18-50) with cannabis use disorders. Approximately 300 participants will be randomized to receive NAC 1200 mg or matched placebo twice daily for 12 weeks. All participants will concurrently receive CE and CM interventions. CM procedures (weekly during treatment) will include escalating schedules of cash reinforcement with resets, targeting (a) retention/adherence, and (b) cannabis abstinence (confirmed by negative qualitative urine cannabinoid testing). The primary analysis will evaluate the impact of NAC versus PBO on cannabis use during the 12-week treatment intervention with the primary outcome measure being the odds of negative urine cannabinoid tests submitted during the 12-week treatment, compared between the two treatment groups.

Funding
NIDA CTN

Principal Investigator
Theresa Winhusen, Phd (Ohio Valley Node, University of Cincinnati/CinARC)

Project Summary
The primary objective of this study is to evaluate the efficacy of buspirone, relative to placebo, in preventing relapse in cocaine-dependent adults in inpatient/residential treatment who are planning to enter outpatient treatment upon inpatient/residential discharge. Secondary objectives include evaluating the impact of buspirone, relative to placebo, on other drug-abuse outcomes and on factors that may mediate buspirone's efficacy as a relapse-prevention treatment.

Funding
NIDA CTN

Principal Investigator
John Rotrosen, MD (Greater New York Node; New York University School of Medicine)

Project Summary
This study will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®) versus buprenorphine-naloxone (BUP-NX, Suboxone®) as pharmacotherapeutic aids to recovery amongst treatment-seeking participants who have completed detoxification and achieved short term abstinence. The primary objective is to compare the effectiveness of XR-NTX versus BUP-NX in promoting the joint outcome of sustained retention in treatment and abstinence after an index admission for opioid dependence. A rescue protocol will enable the study to address additional questions regarding the sequencing of treatments.

Funding
NIDA CTN

Principal Investigator
Mary Jeanne Kreek, MD (Greater New York Node, Rockefeller University)

Project Summary
This study will examine functional variants in three genes (OPRM1, OPRK1, and PDYN) known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated for their contribution to treatment retention, abstinence, and depression in the CTN-0051 trial. Their effects will be compared between the two alternative treatments: extended-release injectable naltrexone (XR-NTX) and buprenorphine-naloxone (BUP-NX). Pharmacogenomics application of study results obtained may allow individual tailoring of these medications. In addition, knowledge pertaining to other aspects of pathophysiology of the receptors systems targeted by XR-NTX or BUP-NX may be gained.

Funding
NIDA CTN

Principal Investigator
John Rotrosen, MD (Greater New York Node; New York University School of Medicine)

Project Summary
This ancillary study is related to CTN-0051, "Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)."
This is an observational study intended to describe opioid use amongst opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with CTN-0051. The primary outcome is to estimate treatment-as-usual rates of opioid use clinical outcomes following discharge to the community in this convenience sample.

Funding
NIDA CTN

Principal Investigator
Yih-Ing Hser, PhD (Integrated Substance Abuse Programs, UCLA); Walter Ling, MD (Integrated Substance Abuse Programs, UCLA)

Project Summary
No studies to date have examined the longer-term effects of Suboxone versus methadone after treatment termination. This project will assess the longer-term outcomes of the large sample of opioid-dependent patients randomly assigned, in the START Study (CTN-0027), to receive Suboxone or methadone for a (planned) six to eight months of treatment. The study team will conduct personal interviews of START participants, approximately 3 to 5 years post-admission, supplemented by (electronic) medical and other records as available. The results will have important implications for optimizing maintenance treatment for opioid dependence. The specific aims of the project are as follows: (1) To determine longer-term outcomes of Suboxone versus methadone treatment received in the START Study; (2) To investigate patient and treatment factors associated with post-START treatment access, utilization, and outcomes; (3) To explore other correlates of long-term outcomes among START participants.

Funding
NIDA CTN

Principal Investigator
Lisa R. Metsch, PhD (Florida Node Alliance, University of Miami Miller School of Medicine)

Project Summary
Project HOPE will evaluate the effectiveness of a brief intervention delivered to HIV-infected drug users recruited from the hospital setting in achieving viral suppression.

The trial comprises: 1) an active patient navigator component: a strengths-based case management approach that includes motivation, physical escort to treatment, and face-to-face booster sessions; and 2) a passive incentives/contingency management component to further motivate and reinforce completion of target behaviors. The primary goal of the study is HIV viral suppression. In addition, the study will also determine linkage and retention in HIV primary care, linkage and retention in drug abuse treatment, and reduction in numbers of hospitalizations

Funding
NIDA CTN

Project Summary
This ancillary study is related to CTN-0049, "Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users."

This study seeks to gain an in-depth understanding of the patient navigation process as it is practiced in the CTN-0049 (Project HOPE) study with HIV positive substance abusers. Specific aims are to: 1) determine how the navigation process differs for the HIV care and substance abuse treatment systems; and 2) assess patient navigators' perceptions of contingency management.

Funding
NIDA CTN

Principal Investigator
Ank Nijhawan, MD (Texas Node, University of Texas Southwestern Medical Center)

Project Summary
This ancillary study is related to CTN-0049, "Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users."

This study seeks to validate the Electronic Medical Record (EMR)-derived prediction model for hospital readmissions within CTN-0049 by comparing predicted 30-day readmission risk with actual 30-day readmission rates among the three different study arms and to refine the EMR-derived prediction model for hospital readmissions based on additional variables collected in the CTN-0049 trial.

Funding
NIDA CTN

Principal Investigators
Walter Ling, MD (Integrated Substance Abuse Programs, UCLA); Andrew Saxon, MD (Pacific Northwest Node, Veteran Affairs Puget Sound Health Care System); Larissa Mooney, MD (Integrated Substance Abuse Programs, UCLA)

Project Summary
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence. Eleven CTP study sites will enroll 300 cocaine-dependent participants who also meet criteria for either past-year opioid dependence or past-year opioid abuse, or past-year opioid use with a history of opioid dependence during the lifetime.

Funding
NIDA CTN

Principal Investigators
David A. Nielsen, PhD (Texas Node, Baylor College of Medicine, Texas); Thomas R. Kosten, MD (Texas Node, BAylor College of Medicine, Texas)

Project Summary
This ancillary study is related to CTN-0048, "Cocaine Use Reduction with Buprenorphine (CURB)."

This study aims to test whether genetic markers in the mu, kappa, and nociceptin/orphanin FQ, OPRL1 receptors are associated with the efficacy of buprenorphine and naltrexone (BUP/NTX) for individuals with cocaine use disorder. Investigators hypothesize that patients with the functional mu polymorphism of OPRM1, rs1799971, A118G, which is non-synonymous Asn to Asp substitution, will have a greater reduction in cocaine use than those without this polymorphism. This hypothesis is based on the reduced rate of relapse during naltrexone treatment in alcoholic patients with this polymorphism compared to those without this polymorphism. The study will also explore several polymorphisms in the kappa and nociceptin/orphanin FQ neurotransmitter systems for their potential effects on treatment response to BUP/NTX based on protective associations of several of these polymorphisms with cocaine and other drug abuse.

Funding
NIDA CTN

Principal Investigators
Michael Bogenschutz, MD (Southwest Node; Center on Alcoholism, Substance Abuse, and Addictions (CASAA), University of New Mexico); Dennis M. Donovan, PhD (Pacific Northwest Node; Alcohol and Drug Abuse Institute, University of Washington)

Project Summary
The present study builds on the knowledge base in developing and implementing screening and brief interventions for harmful and hazardous alcohol use delivered in emergency departments and trauma centers, by transferring and evaluating these procedures when applied to drug use. The study will contrast substance use and substance-related outcomes among patients endorsing problematic substance use during an emergency department (ED) visit who are randomly assigned to one of three treatment conditions: 1) minimal screening only (MSO); 2) screening, assessment, and referral to treatment (if indicated) (SAR); and 3) screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster sessions (BI-B). The primary outcome is days of use of the patient-defined primary problem drug at 3 months following enrollment. Secondary outcomes include change from baseline in days of use of the primary substance, the number days abstinent from all drugs, days of heavy drinking, total quantity of drug use, objective change in drug use based on analysis of hair samples, self-reported consequences of drug and alcohol use, percent entering treatment among those classified as having probable dependence, and ED and other health care utilization.

Funding
NIDA CTN

Principal Investigator
Dennis McCarty, PhD (Oregon Health and Science University)

Project Summary
This ancillary study is related to CTN-0047, "Screening, Motivational Assessment, Referral and Treatment in Emergency Departments (SMART-ED): Evaluation of Screening, Brief Intervention, Referral to Treatment (SBIRT) and Booster Session for Drug Use Patients Presenting for Treatment in the Emergency Department."

Site variations in study outcomes are apparent in clinical trials conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). Systematic and standardized collection of organizational and workforce variables may help elucidate site variations and increase the CTN’s understanding of patient outcomes in protocols. The SMART-ED trial (CTN-0047) will be used to assess the influence of organizational and workforce characteristics on trial operations (e.g., rates of participant recruitment and follow-up) and patient outcomes (e.g., reductions in drug use). This study will build on the analysis of organizational and workforce data in the Baseline Protocol (CTN-0008) and the collection of pre-implementation site data for STAGE-12 (CTN-0031-A-3). The study’s specific aim is the assessment of associations between site organizational and practitioner variables and site differences in clinical trial outcomes.

Funding
NIDA CTN

Principal Investigator
Theresa Winhusen, Phd (Ohio Valley Node, University of Cincinnati/CinARC)

Project Summary
The primary objective of this study is to evaluate the impact of substance abuse treatment as usual plus smoking cessation treatment (TAU+SCT), relative to substance abuse treatment as usual (TAU), on drug abuse outcomes. This is a 10-week, intent-to-treat, 2-group randomized controlled trial with follow-up visits at 3 and 6 months post-smoking quit date. Eligible participants will be randomized to the TAU+SCT or TAU arm. Participants randomized to the TAU+SCT arm will have a target quit smoking day at the end of study week 3. Participants randomized to the TAU+SCT arm will receive individual smoking-cessation counseling consisting of approximately one ten-minute counseling session per week during study weeks 1 through 10. In addition, all TAU+SCT participants will receive extended-release (XL) bupropion (300 mg/day) and, during the post-quit treatment phase, nicotine inhaler (6-16 cartridges per day ad libitum). Finally, all TAU+SCT participants will receive contingency management in which drawings for prizes are given for smoking abstinence as assessed by carbon monoxide (CO) levels during the post-quit phase of the trial (i.e., weeks 4-10). The study will evaluate whether concurrent smoking cessation treatment improves, worsens, or has no effect on drug abuse outcomes in smokers who are in outpatient substance abuse treatment for cocaine or methamphetamine dependence. Secondary objectives include evaluating: 1) the efficacy of TAU+SCT, relative to TAU, in improving smoking outcomes; 2) the safety of TAU+SCT relative to TAU.

Funding
NIDA CTN

Principal Investigator
Dennis McCarty, PhD (Oregon Health and Science University)

Project Summary
This ancillary study is related to CTN-0046, "Smoking Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking Cessation and Stimulant Treatment on Stimulant Dependence".

Site variations in study outcomes are apparent in clinical trials conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). Systematic and standardized collection of organizational and workforce variables may help elucidate site variations and increase the CTN’s understanding of patient outcomes in protocols. The Smoking-Cessation and Stimulant Treatment (CTN-0046) will be used to assess the influence of organizational and workforce characteristics on trial operations (e.g., rates of participant recruitment and follow-up) and patient outcomes (e.g., reductions in drug use). This study will build on the analysis of organizational and workforce data in the Baseline Protocol (CTN-0008) and the collection of pre-implementation site data for STAGE-12 (CTN-0031-A-3). The study’s specific aim is the assessment of associations between site organizational and practitioner variables and site differences in clinical trial outcomes.

Funding
NIDA CTN

Principal Investigator
Tiffany L. Kyle, PhD (Florida Node Alliance; The Center for Drug Free Living, Inc.)

Project Summary
This is an observational study seeking to: (1) Compare the proportion of African American and non-African Americans receiving treatment at substance abuse treatment clinics that have been tested for HIV within the past 12 months; (2) Observe relationships between rates of African Americans who have not been tested and a) the types of testing offered at substance abuse treatment clinics and b) the types of outreach strategies used to engage persons in HIV testing; and (3) assess African American clients’ self-reported barriers to accessing HIV testing, in relation to other ethnicities.

Funding
NIDA CTN

Project Summary
Site variations in study outcomes are apparent in clinical trials conducted within the National Drug Abuse Treatment Clinical Trials Network (CTN). Systematic and standardized collection of organizational and workforce variables may help elucidate site variations and increase the CTN’s understanding of patient outcomes in protocols. The Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders study (CTN-0044) will be used to assess the influence of organizational and workforce characteristics on trial operations (e.g., rates of participant recruitment and follow-up) and patient outcomes (e.g., reductions in drug use). This study will build on the analysis of organizational and workforce data in the Baseline Protocol (CTN-0008) and the collection of pre-implementation site data for STAGE-12 (CTN-0031-A-3). The study’s specific aim is the assessment of associations between site organizational and practitioner variables and site differences in clinical trial outcomes.

Funding

 NIDA CTN 

Principal Investigator

Edward Nunes, MD (Columbia University College of Physicians and Surgeons)

Project Summary

This ancillary study is related to CTN-0044, "Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders."

This study aims to examine the acceptability of a web-delivered Community Reinforcement Approach intervention (Therapeutic Education System - TES) among clients who identify as American Indian/Alaska Native in two non-reservation based treatment programs: City/County Alcohol & Drug Programs (CCADP) in Rapid City, SD (Ohio Valley Node) and Native American Rehabilitation Association of the Northwest (NARA) in Portland, OR (Western States Node).  The study will recruit approximately 40 participants over 4 months and collect both quantitative and qualitative acceptability data.  Qualitative data obtained from post treatment, semi-structured individual interviews will be used to interpret quantitative findings, raise additional intervention-related factors important to participants, and inform possible TES adaptation for this population. 

Funding

NIDA CTN 

Principal Investigators

Aimee Campbell, PhD, MSW (Greater New York Node, New York State Psychiatric Institute, Columbia University); Traci Rieckmann, PhD (Western States Node; Oregon Health & Science University)

Project Summary

This ancillary study is related to CTN-0044, "Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders."

Little is known about how computer-assisted interventions function within clinical treatment settings, provider attitudes towards this technology, and attitude changes of those providers over time. This ancillary study takes advantage of an opportunity to collect data over time from practitioners who have been exposed to an innovative computer-based therapy, the Therapeutic Education System (TES), through the addition of two follow-up surveys. Findings from this study will provide key insights into practitioner attitudes toward technological innovation, and identify important factors related to adoption and implementation, such as organizational characteristics, climate, and culture. Specific aims: 1) Assess change in practitioner attitudes, social norms, and intentions related to computer use, internet use, and web-based interventions from baseline (pre-protocol implementation) to follow-up 1 (post-study treatment completion) and follow-up 2 (post-study outcomes sharing). It is hypothesized that practitioner attitudes, social norms, and intentions will become more positive over time. 2) Assess change in practitioner attitudes, social norms, and intentions related to computer use, internet use, and web-based interventions as a function of number of clients participating in TES and providers' perceived usefulness of TES for the client. It is hypothesized that practitioner attitudes, social norms, and intentions will be positively associated with the number of TES clients assigned and perceived usefulness. 3) Explore the association between practitioner attitudes, social norms, intentions, and organizational variables (readiness, climate, organizational characteristics) at follow-up 1 and follow-up 2. 4) Describe changes in organizational factors (readiness, climate, organizational characteristics) which may serve as facilitators or barriers for adoption or implementation of the computer-assisted intervention TES.

Funding
NIDA CTN

Principal Investigator
Carmen Masson, PhD (Western States Node; University of California, San Francisco)

Project Summary
This study addresses the following questions: (1) What is the proportion and number of racial/ethnic minority participants in each CTN clinical trial, and what is their representation across multiple CTN trials? (2) Do racial/ethnic minority participants in CTN clinical trials experience different attrition than non-minority participants? (3) Do racial/ethnic minority participants in CTN clinical trials experience different outcomes than non-minority participants?

Funding
NIDA CTN

Principal Investigator
Kathy Burlew, PhD (Ohio Valley Node; University of Cincinnati)

Project Summary
This secondary analysis addresses three questions specifically within the African American sample of CTN-0004 participants (CTN-0004 examined the use of Motivational Enhancement Treatment (MET) in subjects seeking treatment for substance abuse): (1) Does the MET group differ from the comparison group (counseling-as-usual - CAU) on retention and substance abuse? (2) Do any patient (age, gender, drug type) or clinical setting (availability of ancillary services) characteristics increase the efficacy of motivational interventions over other interventions? (3) Are the effects of MET more evident immediately for certain subgroups of African Americans but later for other subgroups of African

Funding
NIDA CTN

Principal Investigator
Alyssa Forcehimes, PhD (Southwest Node, Center on Alcoholism, Substance Abuse, and Addictions (CASAA), University of New Mexico)

Project Summary
Establishing a positive relationship between the therapist and patient is recognized as a crucial element for successful psychotherapy regardless of treatment modality. The aim of this study was to test whether participants’ and therapists’ perceptions of therapeutic alliance were associated with total days of substance use across participants in three MET/MI trials in the CTN and whether the relationship between substance use and therapeutic alliance would differ when patients’ race or gender matched their therapists’ race or gender.

Funding
NIDA CTN

Principal Investigator
Dennis M. Donovan, PhD (Pacific Northwest Node; Alcohol and Drug Abuse Institute, University of Washington)

Project Summary
Alcohol use, abuse, and dependence are common among individuals who are dependent on other drugs such as cocaine, other stimulants such as methamphetamine, and opiates. This study examines the pattern of alcohol use, alcohol-related diagnoses, and severity of other problems among a large sample of drug abusing/dependent participants from 10 CTN studies (see Related Studies, below) enrolled in community-based drug treatment programs across the country.

Funding
NIH HEAL Initiative

Principal Investigator
Lisa A. Marsch, Ph.D. (Geisel School of Medicine at Dartmouth College)

Project Summary
As part of an ongoing teleECHO learning collaborative (LC), this study will expand clinical research training in evidence-based quality improvement methods that were central to delivering and sustaining science-based medication-assisted treatment for opioid use disorder (MOUD) within the Vermont Hub-and-Spoke Model (HSM).  Participating primary care practices will be trained in the 1) use of a study-developed toolkit of research and evaluation quality improvement methods intended to expand provider knowledge and performance in the delivery of evidence-based MOUD, 2) systematic tracking of standardized outcome metrics, and 3) sharing of standardized data with other LC members so that practices can use this empirical information to refine their care model over time.  The study will measure changes in providers’ knowledge about best practices for MOUD, their comfort in caring for OUD patients with MOUD, and their performance on all the standardized outcome metrics.