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

Primary Purpose

Substance-Related Disorders

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

D-cycloserine

Placebo

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring cognitive-behavior therapy, d-cycloserine, cognitive enhancer, drug dependence, opiate dependence, exposure, isolated doses of d-cycloserine, isolated doses of matching pill placebo, DCS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Meet DSM-IV criteria for opiate dependence,
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.
Meet study criteria for chronic stress:
- unemployment criteria, and
- affective disorder criteria.

Exclusion Criteria:

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).
Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
Patients receiving medication affecting methadone metabolism (e.g. rifampin).
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).
Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
Pregnancy or current alcohol use.

Sites / Locations

Habit OPCO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DCS-augmented CBT-IC

Placebo-augmented CBT-IC

Arm Description

D-cycloserine-augmented CBT-IC

Placebo-augmented CBT-IC

Outcomes

Primary Outcome Measures

Percentage of Positive Toxicology Swabs for Illicit Substances

The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.

Secondary Outcome Measures

Addiction Severity Index (ASI) Drug Use Composite Score

For the drug use composite scores, each of 13 questions about drug use is divided by its maximum answer value and by the total number of questions in the composite. These individual items are then summed, so that possible total scores range from 0 to 1, with higher scores reflecting greater drug use problem severity.

Full Information

NCT ID

NCT00430573

First Posted

January 31, 2007

Last Updated

May 14, 2018

Sponsor

Boston University Charles River Campus

Collaborators

National Institute on Drug Abuse (NIDA), Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00430573

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

The investigators failed to recruit participants as originally projected.

Study Start Date

February 2007 (Actual)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston University Charles River Campus

Collaborators

National Institute on Drug Abuse (NIDA), Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance-Related Disorders

Keywords

cognitive-behavior therapy, d-cycloserine, cognitive enhancer, drug dependence, opiate dependence, exposure, isolated doses of d-cycloserine, isolated doses of matching pill placebo, DCS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DCS-augmented CBT-IC

Arm Type

Experimental

Arm Description

D-cycloserine-augmented CBT-IC

Arm Title

Placebo-augmented CBT-IC

Arm Type

Placebo Comparator

Arm Description

Placebo-augmented CBT-IC

Intervention Type

Drug

Intervention Name(s)

D-cycloserine

Other Intervention Name(s)

DCS

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Positive Toxicology Swabs for Illicit Substances

Description

Time Frame

Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)

Secondary Outcome Measure Information:

Title

Addiction Severity Index (ASI) Drug Use Composite Score

Description

Time Frame

Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: The primary selection criteria include women and men between the ages of 18 and 65 who: Meet DSM-IV criteria for opiate dependence, 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. Meet study criteria for chronic stress: unemployment criteria, and affective disorder criteria. Exclusion Criteria: 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). Patients with a psychotic or organic mental disorder according to DSM-IV criteria. Patients receiving medication affecting methadone metabolism (e.g. rifampin). 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). Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process. Pregnancy or current alcohol use.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael W. Otto, Ph.D.

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Habit OPCO

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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