We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Stress, Distress Intolerance, and Drug Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430482
First Posted: February 2, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Information provided by (Responsible Party):
Michael Otto, Boston University
  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
Substance Dependence Behavioral: Cognitive Behavioral Therapy Behavioral: Individual Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress, Distress Intolerance, and Drug Dependence

Further study details as provided by Michael Otto, Boston University:

Primary Outcome Measures:
  • Toxicology screens for illicit substances [ Time Frame: Weekly ]

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 ]

Enrollment: 133
Actual 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430482


Locations
United States, Massachusetts
Bay Cove Treatment Center
Boston, Massachusetts, United States, 02114
Habit Management Institute
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Drug Abuse (NIDA)
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:
Responsible Party: Michael Otto, Ph.D., Boston University
ClinicalTrials.gov Identifier: NCT00430482     History of Changes
Other Study ID Numbers: R01DA017904 ( U.S. NIH Grant/Contract )
First Submitted: January 31, 2007
First Posted: February 2, 2007
Last Update Posted: October 12, 2017
Last Verified: April 2017

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

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders