Active Research Studies
Physician-Pharmacist Collaboration in the Management of Patients with Opioid Use Disorder
More information coming soon!
Primary Care Opioid Use Disorders (PROUD) Treatment Trial
This trial is broken into two phases. Phase 1 will assess the current state of health care for persons with opiate use disorders (OUD) and prepare for Phase 2, a pragmatic trial. The pragmatic trials will test whether a collaborative care model of OUD treatment in primary care increases access to medication treatment for OUDs compared to usual care. This trial is scheduled to begin in 2017.
Towards Detecting Cocaine Use Using Smartwatches in the NIDA Clinical Trials Network (AutoSense)
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. 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.
Patient and System-Level Factors Associated with HEDIS AOD-IET Measure Performance Across Health Systems
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.
Electronic Health Records Data Elements Research (EHR-DARE)
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.
Interpretation and Implementation of Title 42 CFR Part 2 for Confidentiality of Patient Drug and Alcohol Use Records: NIDA CTN Stakeholder Snapshot
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).
Emergency Department Initiated Buprenorphine for Opioid Use Disorders
This study builds upon recent research demonstrating that a brief intervention and ED-initiated buprenorphine with ongoing medication assisted treatment for opioid use disorders was superior to referral alone and a brief intervention with facilitated referral to treatment, resulting in nearly twice the percentage of patients who were engaged in formal addiction treatment at 30 days and less self-reported illicit opioid use. The project is a hybrid effectiveness-implementation trial designed to evaluate the effect of Implementation Facilitation compared to baseline ED education on physician prescribing of buprenorphine in the ED and the subsequent effectiveness on engagement in formal addiction treatment at 30 days. This research will produce training materials and algorithms for ED providers to learn and initiate buprenorphine treatment and involves the innovative use of electronic health record screening and decision support tools including a tablet-based software program to facilitated ED diagnosis, evaluation, and treatment provision.
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
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 buporpion extended-release tablets) for methamphetamine use disorder.
Comparing Treatments for HIV-Positive Opioid Users in an Integrated Care Effectiveness Study (CHOICES): Scale-Up
This study builds on lessons learned from the CHOICES pilot study (CTN-0055) and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care settings. Ten HIV primary care clinics will be selected to participate in this open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) (n=200) versus TAU (n=200) in HIV-infected participants with untreated opioid or alcohol use disorders. A follow-up visit at 48 weeks assesses participant safety (e.g. overdose) and continuation on XR-NTX after the 24 weeks of study drug exposure. Co-primary outcomes are 1) number of days of illicit opioid use or heavy drinking in the past 30 days (Aim 1), and 2) HIV viral suppression (HIV-1 RNA < 200 copies/mL) at 24 weeks (Aim 2). Secondary outcomes include CD4 count, HIV care engagement, risk behaviors and quality of life at 24 weeks, as well as sustained HIV viral suppression, overdose, return to substance use (TLFB, ASI-lite), and XR-NTX treatment continuation at 48 weeks.
Opioid Use Disorders in Primary Care Settings: Linking EHRs with PDMP and National Death Index Data Systems
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.
Evaluation of Drug Screening Implementation in Primary Care
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.
Linkage to Hepatitis C Virus (HCV) Care among HIV/HCV Co-infected Substance Users
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.
Gender Differences in the Interrelationships Between Sexual Abuse, Risky Sexual Behavior, and Anxiety/Depression in Treatment Efficacy and Drug Use Over Time Among Individuals with Substance Use Disorders
Investigators will analyze opiate and stimulant users across 3 different treatment modalities from 7 CTN trials focusing on gender differences on the relationship between sexual and physical abuse, anxiety, and depression symptoms; as well as the impact of these factors on SUD treatment efficacy, and HIV risk behaviors.
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 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.
Kaiser Virtual Data Warehouse - Prescription Opioid Users
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 time.
Closed Research Studies
Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)
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 settings.
Screening, Brief Intervention, and Referral to Treatment in Primary Care (SBIRT-PC)
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.
Testing and Linkage to HIV Care in China: a Cluster Randomized Trial
The goal of this study is to determine whether implementation of two structural interventions based on the Seek, Test, Treat and Retain strategy will increase the proportion of HIV-positive, treatment-eligible patients, who are identified and linked to ART and who achieve VL suppression, thereby reducing mortality.
Comparing Treatments for HIV-Positive Opioid Users in an Integrated Care Effectiveness Study (CHOICES)
This study will compare extended-release naltrexone to treatment as usual for opioid dependence in HIV-infected patients.
Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT)
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).
Achieving Cannabis Cessation—Evaluating N-Acetylcystein Treatment (ACCENT)
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.
A Randomized Controlled Evaluation of Buspirone for Relapse-Prevention in Adults with Cocaine Dependence (BRAC)
The primary objective of this study is to evaluate the efficacy of 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.
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)
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.
CTN-0051-A-1: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT) Genetics Study
Long Term Follow-Up of START Patients
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.
Project HOPE: Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users
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.
CTN-0049-A-1: Examining the Patient Navigation Process for HIV and Substance Abuse Treatment
CTN-0049-A-2: Utilization of the Electronic Medical Record to Assess and Predict 30-Day Readmission Risk Among HIV-Infected Inpatients Enrolled in CTN-0049
Cocaine Use Reduction with Buprenorphine (CURB)
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.
CTN-0048-A-1: Pharmacogenetics of Buprenorphine/Naltrexone for Cocaine Dependence in CURB Study
Screening Motivational Assessment and Referral to 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
Smoking Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking Cessation and Stimulant Treatment on Stimulant Dependence
Rates of HIV Testing and Barriers to Testing in African Americans Receiving Substance Abuse Treatment
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.
Web-Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders
The purpose of this study is to evaluate the effectiveness of including an interactive, web-based version of the Community Reinforcement Approach (CRA) intervention plus incentives targeting drug abstinence and treatment participation as part of community-based, outpatient substance abuse treatment.
CTN-0044-A-1: Site Influences on Treatment Effects - Web-Delivery of Evidence-Based Psychosocial Treatment for Substance Use Disorders
CTN-0044-A-2: Acceptability of a Web-Delivered, Evidence-Based, Psychosocial Intervention Among Individuals with Substance Use Disorders Who Identify as American Indian/Alaska Native
CTN-0044-A-3: Web-Tx Organizational and Practitioner Follow-Up
Substance Abuse Treatment Outcomes in Racial/Ethnic Minority Populations
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?
Efficacy of Motivational Enhancement Therapy for African Americans
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 Americans?
Relationships Between Demographic Characteristics of Patients and Therapists, Measures of Therapeutic Process and Therapeutic Alliance, and Outcomes
Pattern of Alcohol Use and Alcohol-Related Diagnoses among Drug Abusing/Dependent Participants
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.