Stress, Distress Intolerance, and Drug Dependence

Not Applicable

Completed

• Conditions: Substance Dependence
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Individual Counseling

• Registration Number: NCT00430482
• Lead Sponsor: Boston University Charles River Campus

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 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.

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 myriad forms of distress-sadness, boredom, anxiety, withdrawal sensations, etc.-that are linked to the stressful lives of drug-dependent individuals, and breaking the link between these emotional cues and drug-related attempts to avoid emotional distress) for intervening with chronically-stressed and treatment-resistant opiate-dependent outpatients. Features of this study of particular relevance to to RFA DA-04-001 include: (1) a focus on opiate-dependent patients undergoing chronic stress; (2) a model for the way in which chronic stress translates into chronic drug use; (2) a focus on the way in which stress-related symptoms serve as trigger for drug use; (3) a focus on both mediators and moderators of treatment that will inform treatment-matching efforts, including a focus on gender differences and emotional avoidance/distress intolerance; and (4) the examination of treatment outcome in a Stage II treatment trial.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2017-05-03
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Results First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

• The primary selection criteria include women and men between the ages of 18 and 65 who:

  1. Meet DSM-IV criteria for opiate dependence,

  2. Maintain a stable dose of methadone for two weeks prior to recruitment and,

  3. 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.

  4. Meet study criteria for chronic stress

     1. unemployment criteria, and
     2. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cognitive Behavioral Therapy	Cognitive Behavioral Therapy
2	Individual Counseling	Individual Counseling

Primary Outcome Measures

Name	Time	Method
Percentage of Positive Toxicology Swabs for Illicit Substances	Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.	The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.

Secondary Outcome Measures

Name	Time	Method
Addiction Severity Index (ASI) Drug Composite Index	Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2	The composite score for drug use is determined by answers to 13 questions on the ASI: A/390 + B/390 + C/390 + D/390 + E/390 + F/390 + G/390 +H/390 + I/390 + J/390 + K/390 + L/52 + M/52. A single score is provided, with possible scores ranging from 0 to 1, with higher scores indicate greater drug use.

Trial Locations

Locations (2)

Habit Management Institute; 🇺🇸 Boston, Massachusetts, United States

Bay Cove Treatment Center; 🇺🇸 Boston, Massachusetts, United States