Status:
COMPLETED
Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
VA Puget Sound Health Care System
Conditions:
Alcohol Abuse
Posttraumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
Detailed Description
Background: Alcohol dependence (AD) is a biologically, genetically based disease, yet the majority of clinically accepted treatments are behaviorally or psychosocially based. PTSD and alcohol use diso...
Eligibility Criteria
Inclusion
- Current primary DSM-IV diagnosis of alcohol dependence(AD)
- Current DSM-IV diagnosis of PTSD
- At least 14 (women) or 21 (men) drinks per week AND at least 2 days of heavy drinking during a consecutive 30 day period in the last 90 days
- Desire to abstain from drinking
- At least 18 years of age
- Good general medical health (see Exclusion Criteria below)
- Capacity to provide informed consent
- English fluency
Exclusion
- Psychiatric/behavioral:
- psychiatric disorder requiring any medication other than anti-depressants (individuals not on a stable dose of an anti-depressant for at least 30 days prior to randomization will be excluded from the study)
- currently taking disulfiram, acamprosate, or naltrexone in the last 30 days or planning to take any of these medications during the 12-week medication phase of the study
- acutely suicidal or homicidal
- current dependence on any other psychoactive substance other than nicotine or cannabis
- a current diagnosis of opioid abuse, use of any opioid- containing medications, methamphetamines, or benzodiazepines during the previous month, or UDA positive for opioids, methamphetamines, benzodiazepines, or sedative hypnotics
- Medical:
- significant acute or chronic medical illness including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic \<110) or orthostatic hypotension (defined as a systolic drop \> 20mmHg after two minutes standing or any drop with dizziness); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo, narcolepsy
- for males only, concomitant use of trazodone (or use in the last 7 days), tadalafil, or vardenafil (or use in the last 3 days) due to increased risk of priapism
- history of prazosin-sensitivity; no prazosin for at least the past 30 days
- women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the study physician or PA to be effective
- signs or symptoms of alcohol withdrawal at the time of initial consent
- legal involvement that could interfere with study treatment
- individuals court ordered for treatment will not be eligible to participate in this study
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01518972
Start Date
September 1 2009
End Date
June 1 2012
Last Update
August 25 2020
Active Locations (1)
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1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108