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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 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.

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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)

Interventions

  • DRUG 2mg Buprenex and 380mg Vivitrol
  • DRUG Placebo (SL pill qd, IM injection q4weeks)

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2019-05-20
Est. Completion 2023-01-30
Phase Phase 2

What the Registry Record Tells You About NCT03852628

The ClinicalTrials.gov registry entry for NCT03852628 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 2mg Buprenex and 380mg Vivitrol is the first listed.

NCT03852628 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.