Acceptance Therapy During Methadone Detoxification

Opiate Dependence Clinical Trial

Official title:

Acceptance Therapy During Methadone Detoxification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439036
• Other study ID #: DA019436-01
• Secondary ID: R01DA019436-01DC
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2007
• Last updated: May 3, 2013
• Start date: July 2006
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

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.
• Drug Counseling

Locations

Country	Name	City	State
United States	University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use		Baseline, twice a week, end of study, one month after the study, 6 months after the study	No
Primary	HIV/HCV risk behaviors		Intake, week 9, week 19	No
Secondary	Retention		twice a week	No
Secondary	Client adherence		twice a week	No
Secondary	Psychosocial functioning		baseline and once a month	No
Secondary	Treatment satisfaction		once a month	No

External Links

•   Treatment Research Clinic