Study to Study of Patient-centered Methadone Treatment (PC-MTP)

This study is currently recruiting participants.
Verified November 2012 by Friends Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01442493
First received: September 7, 2011
Last updated: November 30, 2012
Last verified: November 2012

September 7, 2011
November 30, 2012
September 2011
January 2015   (final data collection date for primary outcome measure)
Urine test for opiates [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
Opiate positive drug test
Same as current
Complete list of historical versions of study NCT01442493 on ClinicalTrials.gov Archive Site
  • Urine cocaine drug test [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Cocaine positive urine drug test
  • HIV risk behavior [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Drug use and sexual HIV risk behavior
  • Criminal behavior [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Days of criminal behavior
  • Quality of Life [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Quality of Life Score
  • Opiate dependence [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence
  • Cocaine dependence [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    DSM-IV criteria for cocaine dependence
  • Urine cocaine drug test [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Cocaine positive urine drug test
  • HIV risk behavior [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Drug use and sexual HIV risk behavior
  • Criminal behavior [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Days of criminal behavior
  • Quality of Life [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Quality of Life Score
  • Opiate dependence [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    DSM-IV criteria for opiate dependence
  • Cocaine dependence [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    DSM-IV criteria for cocaine dependence
Not Provided
Not Provided
 
Study to Study of Patient-centered Methadone Treatment
Reengineering Methadone Treatment: A Clinical Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Opiate Dependence
  • Other: Patient-Centered Methadone Treatment
    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.
  • Other: Methadone Treatment as usual
    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.
  • Experimental: Patient-Centered Methadone Treatment
    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.
    Intervention: Other: Patient-Centered Methadone Treatment
  • Active Comparator: Methadone Treatment as Usual
    Methadone treatment provided as usual in the U.S.
    Intervention: Other: Methadone Treatment as usual
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
No
Contact: Jan Gryzynski, M.A. 410-837-3977 ext 246 jGryzynski@friendsresearch.org
United States
 
NCT01442493
2 R01 DA 015842
Yes
Friends Research Institute, Inc.
Friends Research Institute, Inc.
Not Provided
Principal Investigator: Robert P Schwartz, M.D. Friends Research Institute, Inc.
Friends Research Institute, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP