Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD

Not Applicable

Completed

• Conditions: Combat Disorders; Stress Disorders, Posttraumatic; Alcohol Use Disorders
• Interventions: Drug: prazosin hydrochloride; Drug: placebo

• Registration Number: NCT02226367
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

Brief Summary

The purpose of the study is to evaluate if the drug prazosin:

* will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and

* determine if presence or absence of posttraumatic stress disorder affects treatment.

Detailed Description

The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.

Study Timeline

• Study First Submitted: 2014-07-15
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-27
• Study Start: 2015-01
• Primary Completion: 2018-09-20
• Study Completion: 2018-10-20
• Results First Submitted: 2022-11-07
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Results First Posted: 2023-02-03
• Last Update Posted: 2023-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prazosin hydrochloride	prazosin hydrochloride	Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.
placebo	placebo	Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.

Primary Outcome Measures

Name	Time	Method
Change in Penn Alcohol Craving Scale Score	Change at Week 13 from Baseline	Penn Alcohol Craving Scale (PACS); The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.

Trial Locations

Locations (1)

Madigan Army Medical Center; 🇺🇸 Tacoma, Washington, United States