Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A

Status Not yet recruiting

Clinical Trial Summary

The aims of the current study are to: Aim 1. Develop and refine a novel intervention protocol for individuals receiving medication treatment for opioid use disorder that assertively links them to recovery community centers; Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of assertive linkage to recovery community centers relative to a matched control condition, via a pilot randomized controlled trial; Aim 3. Explain quantitative findings by gaining an in-depth understanding of the intervention's feasibility, acceptability, and preliminary efficacy via qualitative interviews.

Clinical Trial Description

This 5-year project seek to advance our understanding of the clinical and public health utility of recovery community centers and help bridge the gap between clinical treatment and community-based recovery support services. As a first step in this work, the investigators will develop and test a new intervention for peer-facilitated assertive linkage of patients receiving opioid use disorder pharmacotherapy to recovery community centers (RCCL), relative to a matched control condition (CC). This study aims to: Aim 1. Develop, manualize, and refine RCCL and CC protocols via stakeholder feedback. RCCL and CC protocols will be developed and manualized by adapting published community-based mutual-help linkage protocols. Upon preliminary manual development, feedback cycles will be conducted with relevant stakeholders (recovery coaches, recovery community center members, pharmacotherapy prescribers) to inform protocol revision, and promote its feasibility, acceptability, and adoptability. Aim 2. Determine the feasibility, acceptability, and preliminary efficacy of RCCL versus CC, via a pilot randomized controlled trial. More specifically, the feasibility of study procedures and RCCL/CC interventions, acceptability of interventions, and preliminary efficacy of RCCL relative to CC will be assessed. Aim 3. Explain quantitative findings by gaining an in-depth understanding of RCCL feasibility, acceptability, and efficacy via qualitative interviews in a subset of RCCL participants, peer facilitators, and linkage managers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05245513
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Lauren A Hoffman, PhD
Phone	(617) 643-4690
Email	lhoffman1@mgh.harvard.edu
Status	Not yet recruiting
Phase	N/A
Start date	March 1, 2024
Completion date	February 28, 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06021431` - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT	N/A
Completed	`NCT06266572` - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment	Phase 1
Recruiting	`NCT05037682` - Pain and Opioid Management in Older Adults	N/A
Completed	`NCT06200740` - Remotely Observed Methadone Evaluation	N/A
Not yet recruiting	`NCT06441604` - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy	Phase 2
Recruiting	`NCT06028126` - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial	N/A
Completed	`NCT02559973` - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder	Phase 1
Completed	`NCT02593474` - Medication-Assisted Treatment for Youth With Substance Use Disorders	Phase 1
Completed	`NCT02440256` - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial	N/A
Completed	`NCT05587998` - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.	Phase 1
Terminated	`NCT04577144` - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting	`NCT06001437` - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2
Completed	`NCT05546229` - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting	`NCT06416020` - Integrating MOUD in African American Community Settings (Better Together)	N/A
Not yet recruiting	`NCT06104280` - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment	N/A
Recruiting	`NCT06206291` - Cannabidiol for Opioid Addiction	Phase 2
Completed	`NCT05552040` - START NOW in the Treatment of Opioid Addicted Individuals	N/A
Recruiting	`NCT05459922` - Adjunctive Bright Light Therapy for Opioid Use Disorder	N/A
Recruiting	`NCT05343169` - Community-based Education, Navigation, and Support Intervention for Military Veterans	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Enhancing Recovery Capital Amid Opioid Use Disorder Pharmacotherapy: A Pilot Randomized Trial

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms