Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking alcohol dependent individuals. This proposal is a laboratory and treatment outcome study to examine the effects of Prazosin on brief exposure to stress, drug cues and neutral situations on alcohol and drug craving, mood and neurobiological reactivity in a sample of cocaine and/or alcohol dependent individuals. Prazosin will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 120 alcohol dependent men and women, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in alcohol abstinence symptoms; and (c) improvement in alcohol treatment outcomes as measured by increasing abstinence, reduction in alcohol use, increased treatment attendance and decreased relapse risk.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse|
- alcohol and other drug use as measured by weekly urine drug screens/breathalyzer reports and self report of drug use and treatment adherence as measured by frequency of attendance and time to relapse data obtained twice weekly. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Alcohol craving [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- negative mood and anxiety [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Active Comparator: PZ
Prazosin 16 mg/day (tid) will be administered for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
three week dose titration schedule at the start of study with the full dose schedule of 5.0mg in the morning, 5.0mg at 3pm, and 11.0mg at bedtime for 8 weeks and then a 5-day taper in week 12.
Placebo Comparator: PLA
Placebo tablets administered tid for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585780
|Contact: Rachel L Hart, MSfirstname.lastname@example.org|
|United States, Connecticut|
|Yale University School of Medicine: Yale Stress Center||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Rachel L Hart, MS 203-737-4791 email@example.com|
|Principal Investigator:||Rajita Sinha, PhD||Yale University|