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NCT03852628 · ClinicalTrials.gov registry record · Phase 2
Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD
A Phase 2 study, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- Terminated
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT03852628: Clinical Trial Phase 2 study, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
NCT03852628 is a Phase 2 study that was terminated before completion, run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03852628, a Phase 2 study, was terminated before completion, sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid (AUD) and post-traumatic stress disorder (PTSD)
Primary Outcome
Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption and to categorize the World Health Organization Risk Levels of Alcohol Use. An AUD reduction is defined as a WHO risk reduction of at least one category from baseline to week 8. The are 4 different WHO Risk Levels based on the grams of alcohol consumed per day: Very High Risk, High Risk, Medium Risk, and Low Risk (including abstinence).
Interventions
- DRUG 2mg Buprenex and 380mg Vivitrol
- DRUG Placebo (SL pill qd, IM injection q4weeks)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2019-05-20 |
| Est. Completion | 2023-01-30 |
| Phase | Phase 2 |
Why NCT03852628 stopped before completion
NCT03852628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which 2mg Buprenex and 380mg Vivitrol is the first listed.
NCT03852628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03852628 about?
NCT03852628 is a clinical study titled "Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD". Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid (AUD) and post-traumatic stress disorder (PTSD)
What is the current status of trial NCT03852628?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2019-05-20. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT03852628?
The interventions under investigation include: 2mg Buprenex and 380mg Vivitrol (DRUG), Placebo (SL pill qd, IM injection q4weeks) (DRUG).
Who is sponsoring clinical trial NCT03852628?
This trial is sponsored by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03852628's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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