Methadone Monitoring for Insights Into Adverse Events (MEMORIES)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects initiating methadone treatment for opioid addiction who meet elibitility 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
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.