Acceptance Therapy During Methadone Detoxification

NCT00439036 | Completed Phase 1 DMC

• 3 other identifiers: DA019436-01R01DA019436-01DCNBR
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Dependence

Keywords

Opiate; Behavior Therapy; Methadone; Acceptance and Commitment Therapy (ACT)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Retention

  twice a week

• Client adherence

  twice a week

• Psychosocial functioning

  baseline and once a month

• Treatment satisfaction

  once a month

Study Arms (2)

Behavior Therapy: Acceptance and Commitment Therapy

EXPERIMENTAL

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

Drug Counseling

ACTIVE COMPARATOR

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

Interventions

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.

Behavior Therapy: Acceptance and Commitment Therapy

Drug Counseling BEHAVIORAL

Drug Counseling

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Angela L Stotts, Ph.D.

  Associate Professor- University of Texas Houston Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Family Medicine

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: July 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2012
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

US (1)