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Acceptance Therapy During Methadone Detoxification

Primary Purpose

Opiate Dependence

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Behavior Therapy

Drug Counseling

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring Opiate, Behavior Therapy, Methadone, Acceptance and Commitment Therapy (ACT)

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavior Therapy: Acceptance and Commitment Therapy

Drug Counseling

Arm Description

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. --------------------------------------------------------------------------------

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.

Outcomes

Primary Outcome Measures

Substance use

HIV/HCV risk behaviors

Secondary Outcome Measures

Retention

Client adherence

Psychosocial functioning

Treatment satisfaction

Full Information

NCT ID

NCT00439036

First Posted

February 21, 2007

Last Updated

May 3, 2013

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00439036

Brief Title

Acceptance Therapy During Methadone Detoxification

Official Title

Acceptance Therapy During Methadone Detoxification

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opiate Dependence

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Behavior Therapy: Acceptance and Commitment Therapy

Arm Type

Experimental

Arm Description

Arm Title

Drug Counseling

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavior Therapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Drug Counseling

Primary Outcome Measure Information:

Title

Substance use

Time Frame

Baseline, twice a week, end of study, one month after the study, 6 months after the study

Title

HIV/HCV risk behaviors

Time Frame

Intake, week 9, week 19

Secondary Outcome Measure Information:

Title

Retention

Time Frame

twice a week

Title

Client adherence

Time Frame

twice a week

Title

Psychosocial functioning

Time Frame

baseline and once a month

Title

Treatment satisfaction

Time Frame

once a month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angela L Stotts, Ph.D.

Organizational Affiliation

Associate Professor- University of Texas Houston Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

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Acceptance Therapy During Methadone Detoxification

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