Methadone Monitoring for Insights Into Adverse Events

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-05-31

Brief Summary

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Methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. However it has been associated with sudden, unexpected deaths. Two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. This study will look at blood samples for drug levels and genetic components and EKG's (a noninvasive test which reveals heart rhythm). There will be no intervention.

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Detailed Description

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Conditions

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Pain Opiate Addiction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria
* must sign informed consent for methadone treatment prior to being approached for this study
* must sign a written informed consent for this study
* is willing and has a means to return for all scheduled follow-up visits

Exclusion Criteria

* pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism
* use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs
* considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No