Stress, Distress Intolerance, and Drug Dependence

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Substance Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

12 weekly sessions and 3 booster sessions of cognitive behavioral therapy

2

Individual Counseling

Group Type ACTIVE_COMPARATOR

Individual Counseling

Intervention Type BEHAVIORAL

12 weekly sessions and 3 booster sessions of individual counseling

Interventions

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Cognitive Behavioral Therapy

12 weekly sessions and 3 booster sessions of cognitive behavioral therapy

Intervention Type BEHAVIORAL

Individual Counseling

12 weekly sessions and 3 booster sessions of individual counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT ICT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No