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D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780442
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Information provided by (Responsible Party):
Aimee McRae-Clark, Medical University of South Carolina

Brief Summary:
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 or disease Intervention/treatment Phase
Cocaine Use Disorders Drug: D-cycloserine Drug: Placebo Phase 2

Detailed Description:
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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals
Study Start Date : September 2006
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DCS
D-Cycloserine 50 mg is a partial glutamate agonist. Participants received DCS prior to cocaine cue exposure sessions.
Drug: D-cycloserine
50 mg DCS

Placebo Comparator: Placebo
Saline comparator. Participants received placebo prior to cocaine cue exposure sessions.
Drug: Placebo

Primary Outcome Measures :
  1. Cocaine Craving Scale [ Time Frame: Immediately following cue exposure ]
    Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating "Not at all" and 10 indicating "Extremely".

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Subjects must meet DSM-IV criteria for current cocaine dependence. Subjects may meet criteria for abuse, but not dependence on any other substance within the past 60 days with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the testing session will be controlled. Alcohol has also been known to affect HPA function, however to enhance recruitment efforts individuals with alcohol dependence or abuse will be included in the study if they do not require medically supervised detoxification.
  3. Use of one of the following methods of birth control by female subjects: barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
  4. Subjects must live within a 50-mile radius of our research program and have reliable transportation.
  5. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine or alcohol) for 24 hours immediately prior to the GCRC admission.
  6. Subjects must consent to random assignment to the DCS vs. placebo conditions.

Exclusion Criteria:

  1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
  3. Individuals with creatinine clearance of 1.2 or greater as DCS is renally excreted.
  4. Subjects with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
  5. Subjects who are unwilling or unable to maintain abstinent from alcohol and other drugs of abuse (except nicotine) for 24 hours days prior to the cue procedure.
  6. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or cocaine as appropriate) within the past 60 days.
  7. Subjects currently taking B-blockers, anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
  8. Known or suspected hypersensitivity to DCS.
  9. Individuals taking medications that could adversely interact with study medications, including, but not limited to ethionamide, isoniazid, or amino acid supplements.
  10. Subjects with a history of epilepsy or seizure disorder.
  11. Subjects with significant liver impairment as DCS may increase serum transaminases.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00780442

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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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Principal Investigator: Aimee L McRae, Pharm.D. Medical University of South Carolina

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Responsible Party: Aimee McRae-Clark, Professor of Psychiatry and Behavioral Sciences, Medical University of South Carolina Identifier: NCT00780442    
Other Study ID Numbers: HR#16454
First Posted: October 27, 2008    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: July 6, 2018
Last Verified: June 2018
Keywords provided by Aimee McRae-Clark, Medical University of South Carolina:
substance related disorders
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents