Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rajita Sinha, Yale University
ClinicalTrials.gov Identifier:
NCT00585780
First received: December 25, 2007
Last updated: October 27, 2013
Last verified: June 2013

December 25, 2007
October 27, 2013
September 2009
August 2017   (final data collection date for primary outcome measure)
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 ]
cocaine/alcohol 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00585780 on ClinicalTrials.gov Archive Site
Alcohol craving [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
negative mood and anxiety [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
 
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Prazosin
    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.
  • Drug: placebo
    placebo
  • 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.
    Intervention: Drug: Prazosin
  • Placebo Comparator: PLA
    Placebo tablets administered tid for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2018
August 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female individuals, ages 18-50, meeting current DSM-IV criteria for alcohol dependence.
  • ALCOHOLIC SAMPLE: meet current DSM-IV criteria for alcohol dependence
  • COCAINE SAMPLE: meet current DSM-IV criteria for cocaine dependence; documented positive urine toxicology screen for cocaine at intake
  • Subject has voluntarily given informed consent and signed the informed consent document.
  • Able to read English and complete study evaluations.

Exclusion Criteria:

  • Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine;
  • Any current use of opiates;
  • Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or disulfram, except for stabilized on SSRIs
  • Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
  • Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
  • Hypotensive individuals with sitting blood pressure below 100/50 mmHG.
Both
18 Years to 55 Years
No
Contact: Rachel L Hart, MS 203-737-4791 rachel.hart@yale.edu
United States
 
NCT00585780
0705002691, P50-DA016556
Yes
Rajita Sinha, Yale University
Yale University
National Institutes of Health (NIH)
Principal Investigator: Rajita Sinha, PhD Yale University
Yale University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP