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

Sponsor

Seattle Institute for Biomedical and Clinical Research (Other)

Overall Status

Completed

CT.gov ID

NCT02226367

Collaborator

United States Department of Defense (U.S. Fed), VA Puget Sound Health Care System (U.S. Fed)

211

Enrollment

Location

Arms

45.6

Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorders Stress Disorders, Posttraumatic Combat Disorders	Drug: prazosin hydrochloride Drug: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

211 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 20, 2018

Actual Study Completion Date :

Oct 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: prazosin hydrochloride study drug arm prazosin Other Names: prazosin Pfizer Minipress
Placebo Comparator: placebo Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.	Drug: placebo study drug arm placebo Other Names: sugar pill

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: prazosin hydrochloride

study drug arm prazosin

Other Names:

prazosin

Pfizer Minipress

Placebo Comparator: placebo

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

Drug: placebo

study drug arm placebo

Other Names:

sugar pill

Outcome Measures

Primary Outcome Measures

Change in Penn Alcohol Craving Scale score [Change at Week 13 from Baseline]
A self-report paper-and-pencil instrument that assesses various dimensions of craving for alcohol and has been found to have good reliability and validity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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