Status:
TERMINATED
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Conditions:
Substance-Related Disorders
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00430573
Start Date
February 1 2007
End Date
June 1 2009
Last Update
May 17 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Habit OPCO
Boston, Massachusetts, United States, 02118