Alcohol Dependent Clinical Trial
Official title:
Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
This study aims to test the preliminary efficacy of 3.0 mg of guanfacine (GFC) daily versus
placebo in cocaine and/or alcohol dependent individuals. This proposal is a laboratory and
treatment outcome study to examine the effects of guanfacine on brief exposure to stress,
drug cues and neutral situations on cocaine/alcohol craving, mood and neurobiological
reactivity in a sample of cocaine and/or alcohol dependent individuals. Guanfacine will be
beneficial for reduction in stress and drug cue induced craving and related arousal. In a
sample of 60 cocaine and/or 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 cocaine/alcohol
abstinence symptoms; and (c) improvement in cocaine and alcohol treatment outcomes as
measured by increasing abstinence, reduction in cocaine/alcohol use and increased treatment
attendance. Hypothesis 1: Guanfacine will decrease stress-induced cocaine craving, negative
emotions and related arousal in the laboratory as compared to placebo. Hypothesis 2a: As
compared to the PLA group, the GFC group will show significant reductions in protracted
withdrawal symptoms as measured by the CSSA/CIWA during the 9-week treatment period.
Hypothesis 2b: As compared to the PLA group, a higher percentage of the GFC patients will
remain abstinent during the 9-week treatment period with a higher percent of negative
cocaine urines and alcohol-free days.
Hypothesis 2c: The GFC group will show greater adherence to treatment as measured by the
days in treatment as compared to the Pla group.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment