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Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00585780 |
To test the preliminary efficacy of 16.0 mg of Prazosin daily versus placebo in treatment seeking cocaine and/or 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 cocaine/alcohol 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 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.
Condition | Intervention | Phase |
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Cocaine Dependence Alcohol Dependence |
Drug: Prazosin 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: | Prazosin to Reduce Stress-Induced Cocaine/Alcohol Craving and Relapse |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PZ: Active Comparator
Prazosin
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Drug: Prazosin
4.0mg in the morning, 4.0mg at 3pm, and 8.0mg at bedtime for 8 weeks
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PLA: Placebo Comparator
placebo
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Drug: placebo
placebo
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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 Program 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, PhD: Professor ) |
Study ID Numbers: | 0705002691, P50-DA016556 |
Study First Received: | December 25, 2007 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00585780 |
Health Authority: | United States: Institutional Review Board |
Cocaine-Related Disorders Prazosin Mental Disorders Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Stress Alcohol-Related Disorders Cocaine Ethanol |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Adrenergic Antagonists Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions |