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Stress, Distress Intolerance, and Drug Dependence

Primary Purpose

Substance Dependence

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy

Individual Counseling

About this trial

This is an interventional treatment trial for Substance Dependence focused on measuring Substance Dependence, Cognitive-Behavior Therapy, Opiate Dependence, Treatment Moderators

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bay Cove Treatment Center
Habit Management Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Cognitive Behavioral Therapy

Individual Counseling

Outcomes

Primary Outcome Measures

Percentage of Positive Toxicology Swabs for Illicit Substances

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

Addiction Severity Index (ASI) Drug Composite Index

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.

Full Information

NCT ID

NCT00430482

First Posted

January 31, 2007

Last Updated

July 8, 2019

Sponsor

Boston University Charles River Campus

Collaborators

National Institute on Drug Abuse (NIDA), Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00430482

Brief Title

Stress, Distress Intolerance, and Drug Dependence

Official Title

Stress, Distress Intolerance, and Drug Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 2005 (Actual)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston University Charles River Campus

Collaborators

National Institute on Drug Abuse (NIDA), Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Dependence

Keywords

Substance Dependence, Cognitive-Behavior Therapy, Opiate Dependence, Treatment Moderators

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Cognitive Behavioral Therapy

Arm Title

Arm Type

Active Comparator

Arm Description

Individual Counseling

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Other Intervention Name(s)

CBT

Intervention Description

12 weekly sessions and 3 booster sessions of cognitive behavioral therapy

Intervention Type

Behavioral

Intervention Name(s)

Individual Counseling

Other Intervention Name(s)

ICT

Intervention Description

12 weekly sessions and 3 booster sessions of individual counseling

Primary Outcome Measure Information:

Title

Percentage of Positive Toxicology Swabs for Illicit Substances

Description

Time Frame

Weekly assessments with summation over three time periods: baseline, treatment, and eight weeks of follow-up.

Secondary Outcome Measure Information:

Title

Addiction Severity Index (ASI) Drug Composite Index

Description

Time Frame

Baseline, Mid Treatment, Treatment Endpoint, Follow-up Evaluation 1, Follow-up Evaluation 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael W. Otto, Ph.D.

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark H. Pollack, M.D.

Organizational Affiliation

Rush University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven A. Safren, Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bay Cove Treatment Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Habit Management Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21090958

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. Erratum In: Am J Drug Alcohol Abuse. 2011 Jan;37(1):47.

Results Reference

background

PubMed Identifier

23398222

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.

Results Reference

result

PubMed Identifier

23061323

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.

Results Reference

result

PubMed Identifier

25364993

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.

Results Reference

result

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Stress, Distress Intolerance, and Drug Dependence

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