Status:
COMPLETED
Stress, Distress Intolerance, and Drug Dependence
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Conditions:
Substance Dependence
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is designed to evaluate the relative efficacy of a novel treatment (CBT-IC) versus a standard individual drug-counseling treatment. The novel treatment emphasizes exposure to emotional cues...
Detailed Description
This study study is designed to test further the efficacy of Cognitive-Behavior Therapy for Interoceptive Cues (CBT-IC - a treatment with a central focus on enhancing a patient's tolerance to the myri...
Eligibility Criteria
Inclusion
- 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,
- a) fail to achieve "take-home" status for methadone dosing during at least the first four months of methadone treatment, b) test positive on at least two toxicology screens for illicit drugs during the month prior to recruitment c) 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
- (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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT00430482
Start Date
June 1 2005
End Date
July 1 2011
Last Update
July 10 2019
Active Locations (2)
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1
Bay Cove Treatment Center
Boston, Massachusetts, United States, 02114
2
Habit Management Institute
Boston, Massachusetts, United States, 02118