Active Studies Led by GSCN Researchers (includes studies in pre-implementation & conduct)

CTN-0102-XR: Rural Expansion of Medication Treatment for Opioid Use Disorder: Randomized Controlled Pilot Trial of Extended-Release Buprenorphine vs. Sublingual Buprenorphine-naloxone in Rural Settings

CTN-0143: Social Determinants of Health; Needs and Consequences Associated with Substance Use Disorders

This two-year pilot study will explore the feasibility, acceptability, and effectiveness of the most recent formulation of injectable extended-release buprenorphine (XR-BUP) for the treatment of opioid use disorder  in rural settings, as compared to sublingual buprenorphine-naloxone (SL-BUP). The study objectives are to describe the feasibility of implementing the study in rural settings, document the acceptability of the XR-BUP condition, and assess the effectiveness of XR-BUP compared with SL-BUP.

Lead I: Yih-Ing Hser, PhD, UCLA

Lead I: Larissa Mooney, MD, UCLA

Lacking comprehensive understanding of how social determinants of health (SDoH) factors influence patient outcomes, many service delivery systems cannot effectively meet the needs of patients with substance use disorders (SUD), nor do providers of SUD services typically recognize or address SDoH issues. To improve the understanding of SDoH-related needs and consequences among individuals with SUDs, this study will analyze data from a large public health system to identify patterns of SDoH in relation to treatment experiences and outcomes, focusing on SUD treatment initiation, treatment retention, arrest, drug overdose, mortality, as well as utilization of services for health conditions and SDoH issues.  Analyses will also be conducted by sex and by race and ethnicity.

Lead I: Yih-Ing Hser, PhD, UCLA

CTN-0102-C: Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD):EHR Data Collection and Analysis

The CTN-0102-C study (brief title "Rural EHR Data") will continue  to extract and analyze EHR data about patients in the six rural primary care clinics and the TM Vendor that participated in Phase 1 of the CTN-0102 study ("Rural Expansion of Medication Treatment for Opioid Use Disorder [MOUD]") to produce new knowledge on MOUD delivery in rural primary care settings, including examination of changes and outcomes in MOUD delivery in the context of the COVID pandemic.

Lead I: Yih-Ing Hser, PhD, UCLA

Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On (NIH HEAL, 1RM1DA059375-01)

Assessing Functional Outcomes with Reductions in Cannabis Use (NIDA, DA042280-05)

Patient Decision Aid for Opioid Use Disorder (NIDA, RDA045844)

Benzodiazepine Taper With Telehealth-Delivered Cognitive Behavioral Therapy for Patients Using Prescription Opioids (NIDA, R21DA053394)

Active Studies Supported by GSCN Researchers (includes studies in pre-implementation & conduct)

CTN-0100: Optimizing Retention, Duration, and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy

CTN-0139: Collaborative Care for Polysubstance Use in Primary Care Settings (Co-Care) Trial

Although medications for opioid use disorders can markedly reduce overdoses, most people in treatment discontinue treatment prematurely. Retention and outcome quality measures may improve retention and outcomes within Opioid Treatment Programs (OTPs). Research suggests three factors influence the probability that these measures will improve quality: (1) the characteristics of the measures and benchmarks, (2) the knowledge that providers have about how to improve the measures, and (3) the control that providers have over the factors that matter to improve the measure. This study will test approaches for optimizing each of these factors. RTI International, University of California Los Angeles, and Beacon Health Connecticut are partnering with two organizations to develop an effective OTP quality measurement and management system: BayMark Health Services and the Los Angeles County Division of Substance Abuse Prevention and Control. Three interrelated research projects will be implemented to advance OTP quality measurement/management strategy to: (1) create improved retention measures and outcome measures with benchmarks, (2) deliver the measures with information about how to improve retention, and (3) align the OTP quality measures with quality measures at the population-level. Combined, the three projects will test the three factors that theory and research suggest drive the effectiveness of quality measurement. 

PI: Tami Mark, PhD RTI

Site PI: Larissa Mooney, MD, UCLA

Evaluations of treatments for substance use disorders (SUDs) have predominantly focused on abstinence-based primary outcomes, an approach that does not encompass the functional status of patients who may reduce drug use and experience improvements in health and other functional domains. Identification of diverse, clinically relevant outcomes for use in future research may advance treatment development for SUDs. This project will determine if reductions in cannabis use are associated with positive changes in health, psychosocial, and other functional outcomes in individuals with cannabis use disorder (CUD). The project will establish the relationships between reduced cannabis use and improved functional outcomes that are clinically meaningful.

If interested in participating or have questions, contact scousins@mednet.ucla.edu

Lead I: Yih-Ing Hser, PhD, UCLA

Lead I: Larissa Mooney, MD, UCLA

The aim of the study is to test the effectiveness of the Patient Decision Aid for Opioid Use Disorder (PtDA-MAT) by conducting a stepped-wedge cluster-randomized trial in California treatment centers for adults with OUD. Patient outcomes will be tracked by (1) personal assessments (baseline, 3 months, and 6 months): drug use, overdose, healthcare utilization, and (2) clinical and administrative records (over approximately 24 months): drug treatment status and retention, physical and mental health diagnoses, arrest, incarceration, controlled substance use, and mortality. Multilevel models will be applied to test the intervention effects, controlling for possible temporal trends.

If interested in participating or have questions, contact scousins@mednet.ucla.edu

Lead I: Yih-Ing Hser, PhD, UCLA

Lead I: Larissa Mooney, MD, UCLA

This study will examine the efficacy of adding a cognitive behavioral therapy (CBT) program developed and evaluated for patients with anxiety disorders to a benzodiazepine (BZ) taper as an augmentation strategy to improve the success of BZ reduction among patients taking concurrent opioid prescriptions for pain. There is a high risk of mortality including fatal overdose among patients taking opioids and BZs, yet it remains a prevalent problem. Treating underlying anxiety contributing to BZ use and potentially implicated in pain has the potential to decrease BZ use and possibly reduce opioid use. All interventions will be delivered via telehealth to patients recruited from a primary care clinic, where BZ and opioid co-prescribing is common and primary care providers may lack the tools and resources to effectively taper their patients off BZs. Participants who are co-prescribed benzodiazepines and opioids and report elevated anxiety symptoms will be randomized to one of two conditions: (1) BZ taper with telehealth delivered CBT to facilitate taper; (2) BZ taper with health education control. Participants will be assessed on anxiety symptoms, BZ use/dose, opioids use/dose at baseline, post-treatment, and at a 2-month follow-up.

Lead I: Kate Taylor, PhD, UCLA

Lead I: Larissa Mooney, MD, UCLA

Funded by the NIH HEAL Initiative, CTN-0100 is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.

The CTN-0139 study is a cluster-randomized controlled trial testing the effectiveness of the Co-Care collaborative care intervention vs. enhanced usual care (EUC) for reducing polysubstance use and improving health and functioning in adult primary care patients. This nation-wide study will select five sites, each having 1-3 clinics, for participation. The trial will enroll and randomize primary care providers (PCPs); patients with polysubstance use will be subsequently enrolled and will receive the Co-Care intervention or EUC according to the assignment of their PCP. Research staff will screen and enroll patients and PCPs, and patients participate for 12 months. Research assistants follow up with patients and collect data off-site (by telephone, internet).