Stress, Distress Intolerance, and Drug Dependence

• ClinicalTrials.gov Identifier: NCT00430482
• Recruitment Status: Completed
• First Posted: February 2, 2007
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019
• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Drug Abuse (NIDA); Massachusetts General Hospital
• Information provided by (Responsible Party): Michael Otto, Boston University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Substance Dependence	Behavioral: Cognitive Behavioral Therapy; Behavioral: Individual Counseling	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stress, Distress Intolerance, and Drug Dependence
• Actual Study Start Date: June 2005
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Addiction Severity Index (ASI) Drug Composite Index [ Time Frame: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• 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

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 of Results:

McHugh RK, Murray HW, Hearon BA, Pratt EM, Pollack MH, Safren SA, Otto MW. Predictors of dropout from psychosocial treatment in opioid-dependent outpatients. Am J Addict. 2013 Jan;22(1):18-22. doi: 10.1111/j.1521-0391.2013.00317.x.

McHugh RK, Weitzman M, Safren SA, Murray HW, Pollack MH, Otto MW. Sexual HIV risk behaviors in a treatment-refractory opioid-dependent sample. J Psychoactive Drugs. 2012 Jul-Aug;44(3):237-42.

Otto MW, Hearon BA, McHugh RK, Calkins AW, Pratt E, Murray HW, Safren SA, Pollack MH. A randomized, controlled trial of the efficacy of an interoceptive exposure-based CBT for treatment-refractory outpatients with opioid dependence. J Psychoactive Drugs. 2014 Nov-Dec;46(5):402-11. doi: 10.1080/02791072.2014.960110.

Other Publications:

Hearon BA, Calkins AW, Halperin DM, McHugh RK, Murray HW, Otto MW. Anxiety sensitivity and illicit sedative use among opiate-dependent women and men. Am J Drug Alcohol Abuse. 2011 Jan;37(1):43-7. doi: 10.3109/00952990.2010.535581. Epub 2010 Nov 19. Erratum in: Am J Drug Alcohol Abuse. 2011 Jan;37(1):47.

• Responsible Party: Michael Otto, Ph.D., Boston University
• ClinicalTrials.gov Identifier: NCT00430482
• Other Study ID Numbers: R01DA017904 ( U.S. NIH Grant/Contract ); R01DA017904 ( U.S. NIH Grant/Contract )
• First Posted: February 2, 2007
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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