Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse
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|ClinicalTrials.gov Identifier: NCT00585754|
Recruitment Status : Completed
First Posted : January 3, 2008
Last Update Posted : November 30, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependent Alcohol Dependent||Drug: Guanfacine Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse|
|Study Start Date :||April 2006|
|Primary Completion Date :||June 2016|
|Study Completion Date :||June 2016|
|Active Comparator: Guanfacine||
|Placebo Comparator: PLA||
- stress-induced cocaine craving and negative emotions [ Time Frame: 5 years ]
- Drug and alcohol use [ Time Frame: over ninety days ]
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): NCT00585754
|United States, Connecticut|
|Yale University School of Medicine: Yale Stress Center|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Rajita Sinha, PhD||Yale University|