Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Abuse, Posttraumatic Stress Disorder

In brief

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).

Key facts

Study ID

NCT01518972

Run by

Seattle Institute for Biomedical and Clinical Research

People needed

30

Starts

2009-09-01

Expected to finish

2012-06-01

Last updated by the study team

2020-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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