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Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient-Centered Methadone Treatment
Methadone Treatment as usual
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opiate Dependence focused on measuring Methadone Treatment, Opiate dependence, Services research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion Criteria:

  • pregnancy

Sites / Locations

  • Institutes for Behavior Resources REACH
  • University of Maryland Drug Treatment Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient-Centered Methadone Treatment

Methadone Treatment as Usual

Arm Description

Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.

Methadone treatment provided as usual in the U.S.

Outcomes

Primary Outcome Measures

Number of Participants With Opiate Positive Urine Tests
Number of participants with opiate positive urine tests

Secondary Outcome Measures

Number of Participants With Cocaine Positive Urine Tests
Cocaine positive urine drug test
Drug Use HIV Risk Behavior
HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Criminal Behavior
Days of criminal behavior
Global Score on the World Health Organization Quality of Life Measure
Scale from 1 through 5. A higher score reflects a better quality of life.
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Number of participants meeting DSM-IV cocaine dependence criteria

Full Information

First Posted
September 7, 2011
Last Updated
December 5, 2017
Sponsor
Friends Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01442493
Brief Title
Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment
Official Title
Reengineering Methadone Treatment: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether a change in the rules and staff roles in methadone treatment programs will result in greater lengths of stay in treatment and lower rates of heroin and cocaine use, crime and HIV-risk behavior as compared to methadone treatment as usual.
Detailed Description
Early drop-out and premature discharge from methadone treatment is common in the United States and may be associated with drug use and its associated problems. The purpose of this study is to evaluate the effectiveness of a novel approach to the organization methadone treatment in which the patient rules and staff roles of the clinic will be modified for study participants as compared to patients receiving standard methadone treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
Methadone Treatment, Opiate dependence, Services research

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-Centered Methadone Treatment
Arm Type
Experimental
Arm Description
Patient-Centered Methadone Treatment alters the rules and staff roles in methadone treatment as usual in an attempt to increase treatment retention and improve patient outcomes.
Arm Title
Methadone Treatment as Usual
Arm Type
Active Comparator
Arm Description
Methadone treatment provided as usual in the U.S.
Intervention Type
Other
Intervention Name(s)
Patient-Centered Methadone Treatment
Intervention Description
Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.
Intervention Type
Other
Intervention Name(s)
Methadone Treatment as usual
Intervention Description
Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.
Primary Outcome Measure Information:
Title
Number of Participants With Opiate Positive Urine Tests
Description
Number of participants with opiate positive urine tests
Time Frame
12-months post-baseline
Secondary Outcome Measure Information:
Title
Number of Participants With Cocaine Positive Urine Tests
Description
Cocaine positive urine drug test
Time Frame
12-months post-baseline
Title
Drug Use HIV Risk Behavior
Description
HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.
Time Frame
12-months post-baseline
Title
Criminal Behavior
Description
Days of criminal behavior
Time Frame
12-months post-baseline
Title
Global Score on the World Health Organization Quality of Life Measure
Description
Scale from 1 through 5. A higher score reflects a better quality of life.
Time Frame
12-months post-baseline
Title
Number of Participants Meeting DSM-IV Opiate Dependence Criteria
Description
Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
Time Frame
12-months post-baseline
Title
Number of Participants Meeting DSM-IV Cocaine Dependence Criteria
Description
Number of participants meeting DSM-IV cocaine dependence criteria
Time Frame
12-months post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: opiate dependence newly admitted to methadone treatment Exclusion Criteria: pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institutes for Behavior Resources REACH
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
University of Maryland Drug Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21223
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29536342
Citation
Mitchell SG, Monico LB, Lertch E, Kelly SM, Gryczynski J, Jaffe JH, O'Grady KE, Schwartz RP. Counseling Staff's Views of Patient-Centered Methadone Treatment: Changing Program Rules and Staff Roles. J Behav Health Serv Res. 2018 Jul;45(3):506-515. doi: 10.1007/s11414-018-9603-1.
Results Reference
derived

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Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

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