Methadone Monitoring for Insights Into Adverse Events

Completed

Conditions studied: Pain, Opiate Addiction

In brief

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.

Key facts

Study ID

NCT01191242

Run by

Intermountain Health Care, Inc.

People needed

31

Starts

2010-08-01

Expected to finish

2011-05-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Intermountain Medical Center — Murray, Utah, United States
• Discovery House — Taylorsville, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.