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Trial record 92 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

Improving Learning-based Treatment of Cocaine Dependence With Medication

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: NCT01526538
Recruitment Status : Completed
First Posted : February 6, 2012
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Matthew Johnson, Johns Hopkins University

Brief Summary:
This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.

Condition or disease Intervention/treatment Phase
COCAINE-RELATED DISORDERS Drug: d-cycloserine Drug: sugar pill Phase 2

Detailed Description:
Cocaine dependence is a public health problem with substantial morbidity, however no effective pharmacotherapy for cocaine dependence has been approved by the FDA. Unlike previous medication studies that have sought to pharmacologically reduce cocaine reinforcement, seeking or craving, this exploratory clinical trial will test d-cycloserine (DCS) for its ability to improve learning-based behavioral treatment of cocaine dependence. DCS is an NMDA partial agonist that has been shown to robustly improve learning in preclinical models, including extinction of cocaine conditioned place preference and blockade of cocaine reacquisition, and to improve extinction-learning based exposure therapy for multiple anxiety disorders. This Phase II clinical trial will investigate the pharmacological (DCS) enhancement of a behavioral treatment combining contingency management (CM) and novel home-environment exposure therapy sessions for cocaine dependence. High magnitude CM incentives will be used to promote the cocaine abstinence necessary for extinction in home-based exposure sessions. Participants will be randomized into 2 groups: 1. CM with placebo (CM+PL), and 2. CM with DCS (CM+DCS). For 19 days after group assignment, participants will report to the laboratory 3 times per week (Mon, Wed, Fri) to provide urine samples, receive contingent vouchers, and complete assessments of drug use, craving, mood, withdrawal, and quit self-efficacy. DCS (50 mg) or placebo will be administered on Mon, Wed and Fri study visits (at the end of the lab visit before returning to the home environment for exposure sessions during the time of DCS action). Follow-up visits will be conducted at 1 week, 1 month, and 3 months post-CM completion, during which time measures of drug use (self-reported and urinalysis), craving, mood, and withdrawal will be obtained. Comparison of continuous abstinence post-CM between the groups will be the primary outcome measure. During an initial laboratory session, a battery of learning/cognitive tasks will test for forms of learning/cognition enhanced by DCS that might contribute to the treatment effect. This project will test the efficacy of a novel intervention for cocaine dependence that was developed based on a known efficacious cocaine dependence treatment (CM), principles of extinction learning theory, and a medication shown to improve preclinical learning in general, including extinction of cocaine conditioning, and clinical learning-based exposure treatment of anxiety disorders. The study may indicate cost effective additions (home exposure sessions and DCS) to extend CM benefit after the removal of contingencies, and therefore may increase the dissemination of CM in community settings.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Learning-based Treatment of Cocaine Dependence With Medication
Study Start Date : September 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: 50 mg d-cycloserine
active drug condition
Drug: d-cycloserine
50 mg d-cycloserine

Placebo Comparator: Sugar pill
Inactive placebo
Drug: sugar pill

Primary Outcome Measures :
  1. Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml) [ Time Frame: 1 month post-treatment ]
    The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results

  2. Medication Side-effects [ Time Frame: 1 month post-treatment. ]
    self-report of medication side effects (Units of Measure is the count of specific reported effects)

Secondary Outcome Measures :
  1. Learning Task by Itami and Uno [ Time Frame: At the baseline laboratory visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18-60 years of age (> 60 due to age-related effects on cognitive functioning)
  • Satisfy DSM-IV criteria for cocaine dependence (primarily crack)
  • Able to complete all study measures
  • Currently seeking treatment for cocaine dependence

Exclusion Criteria:

  • Meets DSM-IV criteria for dependence on a drug other than cocaine or nicotine (may meet abuse criteria for other drugs)
  • Pregnant, breast feeding, or planning to become pregnant within 3 months
  • If female, do not agree to use an effective means of birth control during the course of treatment (via phone screen)
  • History of seizure disorder, severe hepatic impairment, porphyria, serious head trauma, dementia, or significant cognitive impairment
  • Diagnosis of current major psychiatric disorder besides substance dependence or abuse
  • Reported use of DCS in the past year
  • Illiteracy, as will be determined during in-person screening
  • Concurrently prescribed or using ethionamide or isoniazid (both used to treat tuberculosis)
  • Positive urine result for opioids at screening interview

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): NCT01526538

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United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 212124
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)

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Responsible Party: Matthew Johnson, Assistant Professor, Johns Hopkins University Identifier: NCT01526538     History of Changes
Other Study ID Numbers: R21DA029823 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2012    Key Record Dates
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
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Antibiotics, Antitubercular
Anti-Bacterial Agents
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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
Antitubercular Agents