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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University
ClinicalTrials.gov Identifier:
NCT00430573
First received: January 31, 2007
Last updated: April 18, 2013
Last verified: April 2013
History of Changes

January 31, 2007
April 18, 2013
February 2007
June 2009   (final data collection date for primary outcome measure)
Toxicology screens for illicit substances [ Time Frame: Weekly ] [ Designated as safety issue: No ]
Proportion of positive screens for illicit drug use
Complete list of historical versions of study NCT00430573 on ClinicalTrials.gov Archive Site
Addiction Severity Index, Risk Behavior Survey, Hamilton Anxiety Inventory, Montgomery-Asberg Depression Rating Scale, Anxiety Sensitivity Index [ Time Frame: Baseline, Mid Treatment, End of Treatment, 1-Month Follow-up, 2-Month Follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

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.

This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Substance-Related Disorders
  • Drug: D-cycloserine
    Single dosage prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
    Other Name: DCS
  • Drug: Placebo
    Single dosage prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
  • Experimental: I
    DCS-augmented CBT-IC
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: II
    Placebo-augmented CBT-IC
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00430573
R01 DA017904-S1
Yes
Michael Otto, Boston University
Boston University
Massachusetts General Hospital
Principal Investigator: Michael W. Otto, Ph.D. Boston University
National Institute on Drug Abuse (NIDA)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP