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

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University
ClinicalTrials.gov Identifier:
NCT00430573
First received: January 31, 2007
Last updated: May 23, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Drug: D-cycloserine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Toxicology screens for illicit substances [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
DCS-augmented CBT-IC
Drug: D-cycloserine
Single dosage prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
Other Name: DCS
Placebo Comparator: II
Placebo-augmented CBT-IC
Drug: Placebo
Single dosage prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430573

Locations
United States, Massachusetts
Habit OPCO
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Massachusetts General Hospital
Investigators
Principal Investigator: Michael W. Otto, Ph.D. Boston University
  More Information

No publications provided

Responsible Party: Michael Otto, Ph.D., Boston University
ClinicalTrials.gov Identifier: NCT00430573     History of Changes
Other Study ID Numbers: R01 DA017904-S1, R01DA017904
Study First Received: January 31, 2007
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston University:
cognitive-behavior therapy
d-cycloserine
cognitive enhancer
drug dependence
opiate dependence
exposure
isolated doses of d-cycloserine
isolated doses of matching pill placebo
DCS

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014