Reengineering Methadone Treatment Study of Patient-centered Methadone Treatment

Opiate Dependence Clinical Trial

Official title:

Reengineering Methadone Treatment: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442493
• Other study ID #: 2R01DA015842
• Status: Completed
• Phase: N/A
• First received: September 7, 2011
• Last updated: December 5, 2017
• Start date: September 2011
• Est. completion date: August 2015

Study information

• Verified date: December 2017
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• opiate dependence

• newly admitted to methadone treatment

Exclusion Criteria:

• pregnancy

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Institutes for Behavior Resources REACH	Baltimore	Maryland
United States	University of Maryland Drug Treatment Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Opiate Positive Urine Tests	Number of participants with opiate positive urine tests	12-months post-baseline
Secondary	Number of Participants With Cocaine Positive Urine Tests	Cocaine positive urine drug test	12-months post-baseline
Secondary	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.	12-months post-baseline
Secondary	Criminal Behavior	Days of criminal behavior	12-months post-baseline
Secondary	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.	12-months post-baseline
Secondary	Number of Participants Meeting DSM-IV Opiate Dependence Criteria	Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence	12-months post-baseline
Secondary	Number of Participants Meeting DSM-IV Cocaine Dependence Criteria	Number of participants meeting DSM-IV cocaine dependence criteria	12-months post-baseline