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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00759473 |
The purpose of this study is to explore the use of d-cycloserine to facilitate extinction of response to cocaine cues in cocaine-dependent individuals, in hopes that it may lead to the development of new treatment options for cocaine dependence.
Condition | Intervention | Phase |
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Cocaine Use Disorders |
Drug: cycloserine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | D-Cycloserine Facilitation of Cocaine - Cue Extinction |
Estimated Enrollment: | 72 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
DCS on days 1 and 5, placebo on days 3 and 12
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Drug: cycloserine
50 mg d-cycloserine or placebo taken orally on days 1, 3, 5, and 12 of study
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3: Placebo Comparator
placebo on days 1, 3, 5 and 12
|
Drug: cycloserine
50 mg d-cycloserine or placebo taken orally on days 1, 3, 5, and 12 of study
|
1: Experimental
DCS on days 1, 3, and 5; placebo on day 12
|
Drug: cycloserine
50 mg d-cycloserine or placebo taken orally on days 1, 3, 5, and 12 of study
|
Cocaine dependence remains a serious problem in the United States 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 learning. D-cycloserine (DCS), a partial glutamate agonist, facilitates extinction of associative learning in animal models of fear-conditioning and clinical studies of exposure treatment for anxiety disorders. A recent study demonstrated DCS acceleration of extinction 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:
Contact: Kimber L Price, MSCR, PhD | 843-792-4847 | pricekl@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Kimber L Price, MSCR, Ph.D. 843-792-4325 pricekl@musc.edu | |
Principal Investigator: Kathleen T Brady, MD, PhD | |
Sub-Investigator: Kimber L Price, PhD | |
Sub-Investigator: Therese Killeen, PhD | |
Sub-Investigator: Megan M Moran-Santa Maria, PhD | |
Sub-Investigator: Michael E Saladin, PhD | |
Sub-Investigator: Rickey E Carter, PhD | |
Sub-Investigator: Karen Hartwell, MD | |
Sub-Investigator: Bryan K Tolliver, MD, PhD | |
Sub-Investigator: Peter Kalivas, PhE | |
Sub-Investigator: Robert Malcolm, MD | |
Sub-Investigator: Aimee L McRae-Clark, Pharm D |
Principal Investigator: | Kathleen T Brady, M.D., Ph.D. | Medical University of South Carolina |
Responsible Party: | Medical University of South Carolina ( Kathleen T. Brady, M.D., Ph. D. ) |
Study ID Numbers: | HR#17972, R01-DA-023188, DPMCDA |
Study First Received: | September 24, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00759473 History of Changes |
Health Authority: | United States: Food and Drug Administration |
substance-related disorders |
Antimetabolites Cycloserine Anti-Bacterial Agents Anti-Infective 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 |