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N/A N=78 Randomized Single-blind Treatment

Stress, Distress Intolerance, and Drug Dependence

Substance Dependence

Enrolled (actual)
78
Serious AEs
28.2%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Positive Toxicology Swabs for Illicit Substances — 81.3; 79.1; 86.2; 82.3 percentage of positive toxicology screen

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cognitive Behavioral Therapy (Behavioral); Individual Counseling (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Boston University Charles River Campus
Primary completion
Jul 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Positive Toxicology Swabs for Illicit Substances
81.3; 79.1; 86.2; 82.3; 77.6; 74.8
SECONDARY
Addiction Severity Index (ASI) Drug Composite Index
.23; .21; .20; .16; .17; .18

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 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.

Eligibility 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,
  • 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00430482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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