Stress, Distress Intolerance, and Drug Dependence

Study Overview
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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.

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.

Official Title
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Stress, Distress Intolerance, and Drug Dependence

Conditions
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Substance Dependence

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Individual Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy<br>* 12 weekly sessions and 3 booster sessions of cognitive behavioral therapy<br>* Other names: CBT;|
| Active Comparator: 2<br>Individual Counseling | Behavioral: Individual Counseling<br>* 12 weekly sessions and 3 booster sessions of individual counseling<br>* Other names: ICT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Positive Toxicology Swabs for Illicit Substances | 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. | Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Addiction Severity Index (ASI) Drug Composite Index | 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. | Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Dependence, Cognitive-Behavior Therapy, Opiate Dependence, Treatment Moderators