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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01442493
First received: September 7, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
Other: Patient-Centered Methadone Treatment
Other: Methadone Treatment as usual
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Reengineering Methadone Treatment: A Clinical Trial

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Urine test for opiates [ Time Frame: 12-months post-baseline ] [ Designated as safety issue: No ]
    Opiate positive drug test


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Methadone Treatment as Usual
Methadone treatment provided as usual in the U.S.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • opiate dependence
  • newly admitted to methadone treatment

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442493

Locations
United States, Maryland
Institutes for Behavior Resources REACH
Baltimore, Maryland, United States, 21218
University of Maryland Drug Treatment Center
Baltimore, Maryland, United States, 21223
Sponsors and Collaborators
Friends Research Institute, Inc.
Investigators
Principal Investigator: Robert P Schwartz, M.D. Friends Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01442493     History of Changes
Other Study ID Numbers: 2 R01 DA 015842
Study First Received: September 7, 2011
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Friends Research Institute, Inc.:
Methadone Treatment
Opiate dependence
Services research

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Methadone
Analgesics
Analgesics, Opioid
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014