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NCT02322047 · ClinicalTrials.gov registry record · Phase 2

Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

A Phase 2 study of Alcohol Use Disorder and Posttraumatic Stress Disorder (PTSD), sponsored by Seattle Institute for Biomedical and Clinical Research.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target
1
Study location

NCT02322047 is a Phase 2 study of Alcohol Use Disorder and Posttraumatic Stress Disorder (PTSD) that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 31 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02322047, a Phase 2 study of Alcohol Use Disorder and Posttraumatic Stress Disorder (PTSD), has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo. Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems. Naltrexone is a medication that is FDA approved for treating alcohol problems. This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.

Conditions Studied

Alcohol Use Disorder Posttraumatic Stress Disorder (PTSD)

Interventions

  • DRUG Prazosin
  • DRUG Naltrexone
  • DRUG Placebo (Prazosin)
  • DRUG Placebo (Naltrexone)

Study Locations (1)

Washington

  • VA Puget Sound Healthcare System - Seattle

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2015-03-03
Est. Completion 2018-10-10
Phase Phase 2

Sponsor

Seattle Institute for Biomedical and Clinical Research

43 total trials

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What the Registry Record Tells You About NCT02322047

The ClinicalTrials.gov registry entry for NCT02322047 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Seattle Institute for Biomedical and Clinical Research, which has 43 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 4 interventions - of which Prazosin is the first listed.

NCT02322047 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.

Frequently Asked Questions

What is clinical trial NCT02322047 about?

NCT02322047 is a clinical study titled "Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders". The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and ...

What is the current status of trial NCT02322047?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2015-03-03. Estimated completion is 2018-10-10.

What conditions does trial NCT02322047 study?

This clinical trial studies the following conditions: Alcohol Use Disorder, Posttraumatic Stress Disorder (PTSD).

What interventions are being tested in trial NCT02322047?

The interventions under investigation include: Prazosin (DRUG), Naltrexone (DRUG), Placebo (Prazosin) (DRUG), Placebo (Naltrexone) (DRUG).

Who is sponsoring clinical trial NCT02322047?

This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02322047 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.