Clinical Trials Directory

Trials / Completed

CompletedNCT00439036

Acceptance Therapy During Methadone Detoxification

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
56 (actual)
Sponsor
The University of Texas Health Science Center, Houston · Academic / Other
Sex
All
Age
25 Years – 60 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehavior TherapyThe 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.
BEHAVIORALDrug Counseling

Timeline

Start date
2006-07-01
Primary completion
2010-08-01
Completion
2012-12-01
First posted
2007-02-22
Last updated
2013-05-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00439036. Inclusion in this directory is not an endorsement.