Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
1 other identifier
interventional
158
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedResults Posted
Study results publicly available
February 3, 2023
CompletedFebruary 3, 2023
January 1, 2023
3.7 years
July 15, 2014
November 7, 2022
January 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change at Week 13 from Baseline
Study Arms (2)
prazosin hydrochloride
ACTIVE COMPARATORPrazosin 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 COMPARATORPlacebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.
Interventions
study drug arm prazosin
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Murray Raskind, MD
- Organization
- VA Puget Sound Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Murray Raskind, MD
Department of Veterans Affairs Puget Sound Health Care System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2014
First Posted
August 27, 2014
Study Start
January 1, 2015
Primary Completion
September 20, 2018
Study Completion
October 20, 2018
Last Updated
February 3, 2023
Results First Posted
February 3, 2023
Record last verified: 2023-01