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:
Friends Research Institute, Inc.
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442493
Contacts
| Contact: Jan Gryzynski, M.A. | 410-837-3977 ext 246 | jGryzynski@friendsresearch.org |
Locations
| United States, Maryland | |
| Institutes for Behavior Resources REACH | Recruiting |
| Baltimore, Maryland, United States, 21218 | |
| Principal Investigator: Robert P Schwartz, M.D. | |
| Sub-Investigator: Shannon G Mitchell, Ph.D. | |
| Sub-Investigator: Jerome H Jaffe, M.D. | |
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: | November 30, 2012 |
| 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 Substance-Related Disorders Mental Disorders Methadone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013