Acceptance Therapy During Methadone Detoxification - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00439036

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	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Acceptance Therapy During Methadone Detoxification

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment:	70
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

Contacts

Contact: Ann Garcia, MA	713-500-2804	Ann.D.Garcia@uth.tmc.edu
Contact: Tammy Souter, RN	713-500-2558	Tammy.J.Souter@uth.tmc.edu

Locations

United States, Texas
University of Texas Medical School- Houston; Department of Psychiatry; Mental Sciences Institute	Recruiting
Houston, Texas, United States, 77030
Contact: Ann Garcia, MA 713-500-2804 Ann.D.Garcia@uth.tmc.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Angela L Stotts, Ph.D.

Associate Professor- University of Texas Houston Medical School

More Information

Additional Information:

Treatment Research Clinic This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Texas Health Science Center at Houston ( Angela L. Stotts, PhD )
Study ID Numbers:	DA019436-01, DCNBR
Study First Received:	February 21, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00439036 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Opiate
Behavior Therapy
Methadone
Acceptance and Commitment Therapy (ACT)

Additional relevant MeSH terms:

Respiratory System Agents
Physiological Effects of Drugs
Disorders of Environmental Origin
Central Nervous System Depressants
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Methadone
Sensory System Agents

Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010