Clinical trial NCT00439036: Acceptance Therapy During Methadone Detoxification
Official title: Acceptance Therapy During Methadone Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opiate Dependence
Keywords: Opiate
Behavior Therapy
Methadone
Acceptance and Commitment Therapy (ACT)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Substance use
timeFrame: Baseline, twice a week, end of study, one month after the study, 6 months after the study
measure: HIV/HCV risk behaviors
timeFrame: Intake, week 9, week 19
Secondary outcomes:
measure: Retention
timeFrame: twice a week
measure: Client adherence
timeFrame: twice a week
measure: Psychosocial functioning
timeFrame: baseline and once a month
measure: Treatment satisfaction
timeFrame: once a month
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute
state: Texas
Study officials:
affiliation: Associate Professor- University of Texas Houston Medical School
name: Angela L Stotts, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: