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Sponsored by: |
Medical University of South Carolina |
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Information provided by: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00780442 |
In summary, this pilot study will explore the use of an innovative pharmacologic approach to the treatment of substance dependence through the facilitation of extinction of response to cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this preliminary study, a controlled treatment trial will be planned. This novel approach could have implications for the treatment of multiple substance use disorders including methamphetamine, marijuana and opiate dependence.
Condition | Intervention | Phase |
---|---|---|
Cocaine Use Disorders |
Drug: d-cycloserine |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
Official Title: | D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals |
Enrollment: | 28 |
Study Start Date: | September 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
DCS: Experimental |
Drug: d-cycloserine
50 mg DCS or placebo
|
Placebo: Placebo Comparator |
Drug: d-cycloserine
50 mg DCS or placebo
|
Cocaine dependence remains a serious problem in the US today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified. Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in relapse. Emerging data supports the role of glutamate in extinction of associative learning in animal models of rear-conditioning and clinical studies of exposure treatment for anxiety disorders. A recent study demonstrated DCS acceleration of cocaine-induced conditioned place preference in rats (Botreau et al., 2006). Exploration of DCS in facilitating extinction of response to drug-related cues in humans is needed. The proposed study will extend these innovative and promising findings from the basic science arena and anxiety disorders field in a proof of concept investigation of DCS facilitation of extinction of response to cocaine-related cues in a human laboratory paradigm.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Aimee L McRae, Pharm.D. | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina ( Aimee McRae, Pharm.D. ) |
Study ID Numbers: | HR#16454 |
Study First Received: | October 23, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00780442 History of Changes |
Health Authority: | United States: Food and Drug Administration |
substance related disorders |
Antimetabolites Cycloserine Anti-Bacterial Agents Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Anti-Infective Agents, Urinary Antitubercular Agents Cocaine |
Cycloserine Antimetabolites Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Disorders of Environmental Origin Anti-Infective Agents, Urinary Renal Agents |
Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Mental Disorders Therapeutic Uses Substance-Related Disorders Antitubercular Agents |