Stress, Distress Intolerance, and Drug Dependence

Completed · Not applicable

Conditions studied: Substance Dependence

In brief

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 for drug use as part of a comprehensive, yet brief, treatment strategy. These treatments are delivered to opiate-dependent, often poly-substance dependent, individuals in a comprehensive methadone maintenance program who have failed to respond adequately to current treatments.

Key facts

Study ID

NCT00430482

Run by

Boston University Charles River Campus

People needed

133

Starts

2005-06-01

Expected to finish

2011-07-01

Last updated by the study team

2019-07-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• (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.

Where it is running

• Bay Cove Treatment Center — Boston, Massachusetts, United States
• Habit Management Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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