NCT00430482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
8 years until next milestone

Results Posted

Study results publicly available

July 10, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

6.1 years

First QC Date

January 31, 2007

Results QC Date

May 3, 2017

Last Update Submit

July 8, 2019

Conditions

Substance Dependence

Keywords

Substance DependenceCognitive-Behavior TherapyOpiate DependenceTreatment Moderators

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Addiction Severity Index (ASI) Drug Composite Index

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

Study Arms (2)

1

EXPERIMENTAL

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

2

ACTIVE COMPARATOR

Individual Counseling

Behavioral: Individual Counseling

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

12 weekly sessions and 3 booster sessions of cognitive behavioral therapy

Also known as: CBT
1
Individual CounselingBEHAVIORAL

12 weekly sessions and 3 booster sessions of individual counseling

Also known as: ICT
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bay Cove Treatment Center

Boston, Massachusetts, 02114, United States

Location

Habit Management Institute

Boston, Massachusetts, 02118, United States

Location

Related Publications (4)

  • 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.

    PMID: 21090958BACKGROUND

  • 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.

    PMID: 23398222RESULT

  • 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.

    PMID: 23061323RESULT

  • 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.

    PMID: 25364993RESULT

MeSH Terms

Conditions

Substance-Related DisordersOpioid-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Michael W. Otto, Ph.D.
Organization
Boston University Charles River Campus
mwotto@bu.edu
(617)353-9610

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 2, 2007

Study Start

June 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 10, 2019

Results First Posted

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)