ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00585780
Recruitment Status : Active, not recruiting
First Posted : January 3, 2008
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Alcohol Dependence Drug: Prazosin Drug: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
Study Start Date : September 2009
Actual Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 and time to relapse data obtained twice weekly. [ Time Frame: 5 years ]
    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.

  2. drug use as measured by weekly urine drug screens [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Alcohol craving [ Time Frame: 5 years ]
    per self-report on weekly assessments and in counseling session


Other Outcome Measures:
  1. negative mood and anxiety [ Time Frame: 5 years ]
    per self-report on weekly assessments and in counseling session



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585780


Locations
United States, Connecticut
Yale University School of Medicine: Yale Stress Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Rajita Sinha, PhD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00585780     History of Changes
Other Study ID Numbers: 0705002691
4R01AA020504-05 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2008    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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