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

Conditions

Alcohol Dependence

Trial Phase

Phase 1/Phase 2

Trial Purpose and Description

Trial 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.



Participation Guidelines

Age:
18 Years - 55 Years
Gender:
Both

Eligibility 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.
Sponsor:
National Institutes of Health (NIH)
Yale University
Dates:
September 2009
Last Updated:
October 27, 2013
Study HIC#:

Clinicaltrials.gov ID: NCT00585780