Improving Learning-based Treatment of Cocaine Dependence With Medication

COCAINE-RELATED DISORDERS Clinical Trial

Official title:

Improving Learning-based Treatment of Cocaine Dependence With Medication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526538
• Other study ID #: R21DA029823
• Status: Completed
• Phase: Phase 2
• First received: January 30, 2012
• Last updated: September 12, 2013
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COCAINE-RELATED DISORDERS

Intervention

Drug:
• d-cycloserine
50 mg d-cycloserine
• sugar pill
placebo

Locations

Country	Name	City	State
United States	Behavioral Pharmacology Research Unit	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis benzoylecgonine (cocaine metabolite)(ng/ml)	The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results	1 month post-treatment	No
Primary	Medication side-effects (Units of Measure is the count of specific reported effects)	self-report of medication side effects	1 month post-treatment.	Yes
Secondary	Battery of Learning/Cognitive Assessments	Battery of Learning/Cognitive Assessments will be used to assess learning, extinction, reversal learninging, and memory during the baseline laboratory session.	At the baseline laboratory visit	No