Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); VA Puget Sound Health Care System
• Treatments: Ethanol; Prazosin

Criteria

Inclusion Criteria:

• 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 Criteria:

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