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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01442493
Other study ID # 2R01DA015842
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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