Acceptance Therapy During Methadone Detoxification

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.

Study Overview

• Status: Completed
• Conditions: Opiate Dependence
• Intervention / Treatment: Behavioral: Behavior Therapy; Behavioral: Drug Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. --------------------------------------------------------------------------------	Behavioral: 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.
Active Comparator: 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.	Behavioral: Drug Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Substance use	Baseline, twice a week, end of study, one month after the study, 6 months after the study
HIV/HCV risk behaviors	Intake, week 9, week 19

Secondary Outcome Measures

Outcome Measure	Time Frame
Retention	twice a week
Client adherence	twice a week
Psychosocial functioning	baseline and once a month
Treatment satisfaction	once a month

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Angela L Stotts, Ph.D., Associate Professor- University of Texas Houston Medical School

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 21, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (Estimate): February 22, 2007

Study Record Updates

• Last Update Posted (Estimate): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Methadone; Acceptance and Commitment Therapy (ACT); Behavior Therapy; Opiate
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: DA019436-01; DCNBR (NIDA); R01DA019436-01 (U.S. NIH Grant/Contract)