Stress, Distress Intolerance, and Drug Dependence
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Substance Dependence |
Behavioral: Cognitive Behavioral Therapy Behavioral: Individual Counseling |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Stress, Distress Intolerance, and Drug Dependence |
- Toxicology screens for illicit substances [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- Addiction Severity Index, Risk Behavior Survey, Hamilton Anxiety Inventory, Montgomery-Asberg Depression Rating Scale, Anxiety Sensitivity Index [ Time Frame: Baseline, Mid Treatment, End of Treatment, 1-Month Follow-up, 2-Month Follow-up ] [ Designated as safety issue: No ]
| Enrollment: | 133 |
| Study Start Date: | June 2005 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Cognitive Behavioral Therapy
|
Behavioral: Cognitive Behavioral Therapy
12 weekly sessions and 3 booster sessions of cognitive behavioral therapy
Other Name: CBT
|
|
Active Comparator: 2
Individual Counseling
|
Behavioral: Individual Counseling
12 weekly sessions and 3 booster sessions of individual counseling
Other Name: ICT
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Massachusetts | |
| Habit Management Institute | |
| Boston, Massachusetts, United States, 02118 | |
| Bay Cove Treatment Center | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Michael W. Otto, Ph.D. | Boston University |
| Principal Investigator: | Mark H. Pollack, M.D. | Rush University |
| Principal Investigator: | Steven A. Safren, Ph.D. | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | Michael Otto, Ph.D., Boston University |
| ClinicalTrials.gov Identifier: | NCT00430482 History of Changes |
| Other Study ID Numbers: | R01 DA17904 |
| Study First Received: | January 31, 2007 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Substance Dependence Cognitive-Behavior Therapy Opiate Dependence Treatment Moderators |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013