Acceptance Therapy During Methadone Detoxification

NCT ID: NCT00439036

Last Updated: 2013-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2012-12-31

Brief Summary

The purpose of this study is to develop an opiate detoxification behavior therapy based on current Acceptance and Commitment Therapy (ACT) theory and method, and to test its feasibility and promise in the context of voluntary methadone detoxification.

Detailed Description

This Stage I pilot study will employ a randomized, controlled, between groups design in which 70 opiate dependent patients seeking methadone detoxification will be randomized into one of two treatment conditions: ACT opiate detoxification therapy or Drug Counseling. Both therapies will be delivered in the context of a 5-month methadone dose reduction based on a linear dosing strategy. Efficacy variables will include: (1) abstinence rates during and 1-month after detoxification as assessed by regular urine screens; (2) retention of patients in treatment; and (3) patient satisfaction and treatment acceptability. Reduction in HIV/Hepatitis C risk behaviors and changes in psychosocial functioning (e.g., employment, family, legal) will also be explored, along with mediators/moderators of the therapy (i.e., experiential avoidance). Subjects will be recruited from Houston area methadone clinics and the general community via advertising and will receive methadone as part of this protocol. A 2-4 week stabilization period will precede the 5-month methadone dose reduction. During the dose reduction, participants will attend the clinic twice each week and will receive weekly therapy. Participants will be contacted for follow up assessments up to one month post treatment.

Conditions

Opiate Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavior Therapy: Acceptance and Commitment Therapy

The Act-ODT intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.

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Group Type: EXPERIMENTAL

Behavior Therapy

Intervention Type: BEHAVIORAL

The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.

Drug Counseling

The Drug Counseling intervention consists of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.

Group Type: ACTIVE_COMPARATOR

Drug Counseling

Intervention Type: BEHAVIORAL

Interventions

Behavior Therapy

The Act-ODT intervention will consist of 24 50-minute sessions delivered weekly in the context of a methadone dose reduction program. Sessions will begin during the methadone run-up/stabilization period approximately 4 weeks prior to the onset of dose reduction and will continue through the 20 week detoxification.

Intervention Type: BEHAVIORAL

Drug Counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 25 through 60
• Dependent upon opiates (heroin/methadone) according to DSM-IV criteria
• Using heroin/methadone for at least 5 years
• Endorse 7 or higher on a 10-point motivation for opiate detoxification item
• In good physical and psychiatric health
• Able to read, speak, and understand English
• Willing and able to meet study requirements
• Willing to participate in the 1 month follow up session
• Able to provide the name of at least one person who can generally locate them
• Attending a licensed methadone clinic regularly with opiate (other than methadone) negative urine screens in the past month.
• Intake screen negative for opiates (other than methadone)
• >110 lbs & body mass index between 18 and 28 kg/m2

Exclusion Criteria

• Younger than 25 and older than 60 years of age
• Current dependence on other substances
• Severe medical, cognitive, and/or psychiatric impairment that precludes cooperation with study protocol
• Current and severe psychiatric symptoms requiring medical attention
• Current substance withdrawal symptoms requiring medical attention
• Unable to read, speak, and understand English
• Unwillingness of women of child bearing age to use contraception
• Currently receiving other psychosocial therapy for substance abuse (12-step meetings are ok)
• Impending incarceration
• Unable or unwilling to meet study requirements, including provision of signed consent
• Less than 7 on a 10-point motivation for opiate detoxification scale
• no documentation of monitored methadone use
• non-methadone opiate positive urine screen in the past month according to self-report

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Angela Stotts

Associate Professor - Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela L Stotts, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor- University of Texas Houston Medical School

Locations

University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute

Houston, Texas, United States

Countries

United States

Other Identifiers

R01DA019436-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DCNBR

Identifier Type: -

Identifier Source: secondary_id

DA019436-01

Identifier Type: -

Identifier Source: org_study_id