Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University; Boston University Charles River Campus
• Collaborators: Massachusetts General Hospital; National Institute on Drug Abuse (NIDA)
• Treatments: Cycloserine

Criteria

Inclusion criteria:

The primary selection criteria include women and men between the ages of 18 and 65 who:

1. Meet DSM-IV criteria for opiate dependence,

2. Maintain a stable dose of methadone for two weeks prior to recruitment and:

• fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment,

• test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment

• have never achieved two consecutive toxicology screens free of illicit substances since entering the current treatment episode.

3. Meet study criteria for chronic stress:

• unemployment criteria, and

• affective disorder criteria.

Exclusion Criteria:

1. Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).

2. Patients with a psychotic or organic mental disorder according to DSM-IV criteria.

3. Patients receiving medication affecting methadone metabolism (e.g. rifampin).

4. Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).

5. Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.

6. Pregnancy or current alcohol use.