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

NCT ID: NCT00430573

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-06-30

Brief 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.

Detailed Description

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

Conditions

Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DCS-augmented CBT-IC

D-cycloserine-augmented CBT-IC

Group Type: EXPERIMENTAL

D-cycloserine

Intervention Type: DRUG

Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Placebo-augmented CBT-IC

Placebo-augmented CBT-IC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Interventions

D-cycloserine

Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Intervention Type: DRUG

Placebo

Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

Intervention Type: DRUG

Other Intervention Names

DCS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Michael Otto

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael W. Otto, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Habit OPCO

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01DA017904

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01 DA017904-S1

Identifier Type: -

Identifier Source: org_study_id