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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00585754 |
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 | Intervention | Phase |
---|---|---|
Cocaine Dependent Alcohol Dependent |
Drug: Guanfacine Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Guanfacine to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Guan.: Active Comparator |
Drug: Guanfacine
1.5mg BID
|
PLA: Placebo Comparator |
Drug: Placebo
placebo
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keri L Bergquist, Psy.D. | 203-974-7360 | keri.bergquist@yale.edu |
United States, Connecticut | |
Yale University School of Medicine: Research Prog. on Stress, Addiction, and Psychopathology | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Keri L Bergquist, Psy.D 203-974-7360 keri.bergquist@yale.edu |
Principal Investigator: | Rajita Sinha, PhD | Yale University |
Responsible Party: | Yale University School of Medicine ( Rajita Sinha, Ph.D. Professor ) |
Study ID Numbers: | 0512000886, P50-DA016556 |
Study First Received: | December 22, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585754 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Guanfacine Stress |
Cardiovascular Agents Antihypertensive Agents Cocaine Adrenergic Agonists Ethanol |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Guanfacine Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions |