Improving Learning-based Treatment of Cocaine Dependence With Medication

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew Johnson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01526538
First received: January 30, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
COCAINE-RELATED DISORDERS
Drug: d-cycloserine
Drug: sugar pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Learning-based Treatment of Cocaine Dependence With Medication

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Urinalysis benzoylecgonine (cocaine metabolite)(ng/ml) [ Time Frame: 1 month post-treatment ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    self-report of medication side effects


Secondary Outcome Measures:
  • Battery of Learning/Cognitive Assessments [ Time Frame: At the baseline laboratory visit ] [ Designated as safety issue: No ]
    Battery of Learning/Cognitive Assessments will be used to assess learning, extinction, reversal learninging, and memory during the baseline laboratory session.


Enrollment: 135
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg d-cycloserine
active drug condition
Drug: d-cycloserine
50 mg d-cycloserine
Placebo Comparator: Sugar pill
Inactive placebo
Drug: sugar pill
placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526538

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 212124
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Matthew Johnson, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01526538     History of Changes
Other Study ID Numbers: R21DA029823
Study First Received: January 30, 2012
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014