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

Primary Purpose

Alcohol Use Disorders, Stress Disorders, Posttraumatic, Combat Disorders

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

prazosin hydrochloride

placebo

About this trial

This is an interventional treatment trial for Alcohol Use Disorders focused on measuring prazosin, alcohol use disorders, posttraumatic stress disorder, PTSD, combat trauma, military, alpha-1 adrenoreceptor antagonist

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder
Participant in Army Substance Abuse Program (6 or 12 week program)
Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men)
Good general medical health (see Exclusion Criteria below)
Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study.
Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to Baseline
Capacity to provide informed consent
English fluency

Exclusion Criteria

Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal substance dependence or abuse.
Signs or symptoms of alcohol withdrawal at the time of initial consent
Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar disorder, or cognitive disorder.
Suicide attempt or suicidal ideation with intent in the past month.
Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <100) or orthostatic hypotension (defined as a systolic drop > 20 mmHg after two minutes standing accompanied by lightheadedness or syncope); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's disease. Liver function tests more than 5 times the upper limit.
Concomitant use of trazodone (due to increased risk of priapism). There will be a two week trazodone washout period before the baseline visit.
Concomitant use of an alpha-1 blocker medication or insulin
Use of prazosin in the 4 weeks prior to Baseline.
History of prazosin sensitivity/allergy

Sites / Locations

Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

prazosin hydrochloride

placebo

Arm Description

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. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.

Outcomes

Primary Outcome Measures

Change in Penn Alcohol Craving Scale Score

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02226367

First Posted

July 15, 2014

Last Updated

January 17, 2023

Sponsor

Seattle Institute for Biomedical and Clinical Research

Collaborators

United States Department of Defense, VA Puget Sound Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT02226367

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

September 20, 2018 (Actual)

Study Completion Date

October 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seattle Institute for Biomedical and Clinical Research

Collaborators

United States Department of Defense, VA Puget Sound Health Care System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorders, Stress Disorders, Posttraumatic, Combat Disorders

Keywords

prazosin, alcohol use disorders, posttraumatic stress disorder, PTSD, combat trauma, military, alpha-1 adrenoreceptor antagonist

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

158 (Actual)

8. Arms, Groups, and Interventions

Arm Title

prazosin hydrochloride

Arm Type

Active Comparator

Arm Description

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.

Intervention Type

Drug

Intervention Name(s)

prazosin hydrochloride

Other Intervention Name(s)

prazosin, Pfizer Minipress

Intervention Description

study drug arm prazosin

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

sugar pill

Intervention Description

study drug arm placebo

Primary Outcome Measure Information:

Title

Change in Penn Alcohol Craving Scale Score

Description

Time Frame

Change at Week 13 from Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder Participant in Army Substance Abuse Program (6 or 12 week program) Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men) Good general medical health (see Exclusion Criteria below) Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study. Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to Baseline Capacity to provide informed consent English fluency Exclusion Criteria Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal substance dependence or abuse. Signs or symptoms of alcohol withdrawal at the time of initial consent Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar disorder, or cognitive disorder. Suicide attempt or suicidal ideation with intent in the past month. Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic <100) or orthostatic hypotension (defined as a systolic drop > 20 mmHg after two minutes standing accompanied by lightheadedness or syncope); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's disease. Liver function tests more than 5 times the upper limit. Concomitant use of trazodone (due to increased risk of priapism). There will be a two week trazodone washout period before the baseline visit. Concomitant use of an alpha-1 blocker medication or insulin Use of prazosin in the 4 weeks prior to Baseline. History of prazosin sensitivity/allergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Murray Raskind, MD

Organizational Affiliation

Department of Veterans Affairs Puget Sound Health Care System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

12. IPD Sharing Statement

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

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