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NCT06651177 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder
A Phase 2 study of Opioid Use Disorder and Opioid Use Disorder, Moderate, sponsored by T. John Winhusen, PhD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 310
- Enrollment target
- 10
- Study locations
NCT06651177: Recruiting Phase 2 study of Opioid Use Disorder and Opioid Use Disorder, Moderate, sponsored by T. John Winhusen, PhD.
NCT06651177 is a Phase 2 study of Opioid Use Disorder and Opioid Use Disorder, Moderate that is actively recruiting participants, run by T. John Winhusen, PhD. The registered enrollment target is 310 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06651177, a Phase 2 study of Opioid Use Disorder and Opioid Use Disorder, Moderate, is actively recruiting participants, sponsored by T. John Winhusen, PhD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 310 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
Primary Outcome
MOUD is defined as buprenorphine (BUP). The receipt of BUP will be assessed thorough self-report collected through a Timeline Follow-Back (TLFB) procedure and will be partially verified through urine drug screens.
Conditions Studied
Interventions
- DRUG Tirzepatide
- OTHER Placebo
Study Locations (10)
Florida
- Gateway Community Services - Jacksonville
- IBIS Behavioral Health - Tampa
West Virginia
- Marshall Health - Huntington
- Healthy Minds/Chestnut Ridge - Morgantown
California
- Tarzana Treatment Centers - Tarzana
Illinois
- Ruth M. Rothstein CORE Center - Chicago
Missouri
- The Gibson Center for Behavioral Change - Cape Girardeau
South Carolina
- Prisma Health - Greenville
Tennessee
- Vanderbilt University Medical Center - Nashville
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2025-12-12 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT06651177 shows while recruiting
NCT06651177 is an interventional study that assigns participants to a tested intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Tirzepatide is the first listed.
NCT06651177 lists 10 locations in 8 states (Florida, West Virginia, California).
Frequently Asked Questions
What is clinical trial NCT06651177 about?
NCT06651177 is a clinical study titled "Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder". The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
What is the current status of trial NCT06651177?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 310 participants. The study started on 2025-12-12. Estimated completion is 2027-06-30.
What conditions does trial NCT06651177 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe.
What interventions are being tested in trial NCT06651177?
The interventions under investigation include: Tirzepatide (DRUG), Placebo (OTHER).
Who is sponsoring clinical trial NCT06651177?
This trial is sponsored by T. John Winhusen, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06651177 being conducted?
This trial has 10 study locations across California, Florida, Illinois, Missouri, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06651177's enrollment target sits among peer trials
310 53rd of 257 higher than 205 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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