Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
This study has been completed.
Sponsor:
Boston University
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
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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 National Institute on Drug Abuse (NIDA):
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 ]
| Estimated 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:
- 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.
Contacts and Locations
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 |
| Study First Received: | January 31, 2007 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
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 Mental Disorders Cycloserine Nootropic Agents Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013