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Improving Learning-based Treatment of Cocaine Dependence With Medication

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

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 6, 2012
Results First Submitted Date  ICMJE September 10, 2015
Results First Posted Date  ICMJE February 15, 2017
Last Update Posted Date February 15, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • 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
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
  • 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
  • Medication side-effects (Units of Measure is the count of specific reported effects) [ Time Frame: 1 month post-treatment. ]
    self-report of medication side effects
Change History Complete list of historical versions of study NCT01526538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
Learning Task by Itami and Uno [ Time Frame: At the baseline laboratory visit ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2012)
Battery of Learning/Cognitive Assessments [ Time Frame: At the baseline laboratory visit ]
Battery of Learning/Cognitive Assessments will be used to assess learning, extinction, reversal learninging, and memory during the baseline laboratory session.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Learning-based Treatment of Cocaine Dependence With Medication
Official Title  ICMJE Improving Learning-based Treatment of Cocaine Dependence With Medication
Brief Summary This study will test the efficacy of d-cycloserine in enhancing response to learning-based treatment for cocaine dependence, specifically contingency management.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COCAINE-RELATED DISORDERS
Intervention  ICMJE
  • Drug: d-cycloserine
    50 mg d-cycloserine
  • Drug: sugar pill
    placebo
Study Arms  ICMJE
  • Experimental: 50 mg d-cycloserine
    active drug condition
    Intervention: Drug: d-cycloserine
  • Placebo Comparator: Sugar pill
    Inactive placebo
    Intervention: Drug: sugar pill
Publications * Johnson MW, Bruner NR, Johnson PS, Silverman K, Berry MS. Randomized controlled trial of d-cycloserine in cocaine dependence: Effects on contingency management and cue-induced cocaine craving in a naturalistic setting. Exp Clin Psychopharmacol. 2019 Aug 1. doi: 10.1037/pha0000306. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
52
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2012)
167
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01526538
Other Study ID Numbers  ICMJE R21DA029823( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Johnson, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP