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Acceptance Therapy During Methadone Detoxification

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Angela Stotts, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00439036
First received: February 21, 2007
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
 Behavioral: Behavior Therapy
Behavioral: Drug Counseling
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acceptance Therapy During Methadone Detoxification

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Substance use [ Time Frame: Baseline, twice a week, end of study, one month after the study, 6 months after the study ] [ Designated as safety issue: No ]
  • HIV/HCV risk behaviors [ Time Frame: Intake, week 9, week 19 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Retention [ Time Frame: twice a week ] [ Designated as safety issue: No ]
  • Client adherence [ Time Frame: twice a week ] [ Designated as safety issue: No ]
  • Psychosocial functioning [ Time Frame: baseline and once a month ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: once a month ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: July 2006
Study Completion Date: December 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439036

Locations
United States, Texas
University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Angela L Stotts, Ph.D. Associate Professor- University of Texas Houston Medical School
  More Information

No publications provided

Responsible Party: Angela Stotts, Associate Professor - Family Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00439036     History of Changes
Other Study ID Numbers: DA019436-01, R01DA019436-01, DCNBR
Study First Received: February 21, 2007
Last Updated: May 3, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center, Houston:
Opiate
Behavior Therapy
Methadone
Acceptance and Commitment Therapy (ACT)

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 13, 2013