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Completed

NCT Number: NCT00439036

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavior Therapy

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

Behavioral

Primary outcomes

  1. Substance use

    Time frame: Baseline, twice a week, end of study, one month after the study, 6 months after the study

  2. HIV/HCV risk behaviors

    Time frame: Intake, week 9, week 19

Secondary outcomes

  1. Retention

    Time frame: twice a week

  2. Client adherence

    Time frame: twice a week

  3. Psychosocial functioning

    Time frame: baseline and once a month

  4. Treatment satisfaction

    Time frame: once a month

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Feb 22, 2007
Registry last updated
May 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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