Clinical trial NCT00430482: Stress, Distress Intolerance, and Drug Dependence
Official title: Stress, Distress Intolerance, and Drug Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Dependence
Keywords: Substance Dependence
Cognitive-Behavior Therapy
Opiate Dependence
Treatment Moderators
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Massachusetts General Hospital
First posted: 2007-02-02
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Positive Toxicology Swabs for Illicit Substances
timeFrame: Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.
Secondary outcomes:
measure: Addiction Severity Index (ASI) Drug Composite Index
timeFrame: Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Bay Cove Treatment Center
state: Massachusetts
city: Boston
country: United States
facility: Habit Management Institute
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael W. Otto, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University
name: Mark H. Pollack, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Steven A. Safren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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. doi: 10.1080/02791072.2012.703507.
citation: 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.