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

Boston University Charles River Campus

Status and phase: Terminated; Phase 2

Conditions: Substance-Related Disorders

Treatments: Drug: D-cycloserine; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00430573

R01DA017904 (U.S. NIH Grant/Contract)

R01 DA017904-S1

Details and patient eligibility

About

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.

Full description

This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

DCS-augmented CBT-IC

Experimental group

Description:

D-cycloserine-augmented CBT-IC

Treatment:

Drug: D-cycloserine

Placebo-augmented CBT-IC

Placebo Comparator group

Description:

Placebo-augmented CBT-IC

Treatment:

Drug: Placebo