Stress, Distress Intolerance, and Drug Dependence

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University
ClinicalTrials.gov Identifier:
NCT00430482
First received: January 31, 2007
Last updated: May 23, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Toxicology screens for illicit substances [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430482

Locations
United States, Massachusetts
Habit Management Institute
Boston, Massachusetts, United States, 02118
Bay Cove Treatment Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Boston University
Massachusetts General Hospital
Investigators
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:
McHugh RK, Murray HW, Hearon BA, Pratt EM, Pollack MH, Safren SA, Otto MW. (in press). Predictors of dropout from psychosocial treatment in opioid-dependent outpatients. American Journal on Addictions.

Responsible Party: Michael Otto, Ph.D., Boston University
ClinicalTrials.gov Identifier: NCT00430482     History of Changes
Other Study ID Numbers: R01 DA17904, R01DA017904
Study First Received: January 31, 2007
Last Updated: May 23, 2013
Health Authority: United States: Federal Government

Keywords provided by Boston University:
Substance Dependence
Cognitive-Behavior Therapy
Opiate Dependence
Treatment Moderators

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014