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
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug: Prazosin
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Alcohol craving [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • negative mood and anxiety [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
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)
Arms Assigned Interventions
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.
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.
Placebo Comparator: PLA
Placebo tablets administered tid for 12 weeks with contingency management vouchers for treatment attendance and manualized CBT relapse prevention counseling.
Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585780

Contacts
Contact: Rachel L Hart, MS 203-737-4791 rachel.hart@yale.edu

Locations
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    rachel.hart@yale.edu   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University
  More Information

No publications provided

Responsible Party: Rajita Sinha, Professor, Yale University
ClinicalTrials.gov Identifier: NCT00585780     History of Changes
Other Study ID Numbers: 0705002691, P50-DA016556
Study First Received: December 25, 2007
Last Updated: October 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Prazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014