Clinical trial NCT01191242: Methadone Monitoring for Insights Into Adverse Events
Official title: Methadone Monitoring for Insights Into Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Opiate Addiction
Keywords: methadone
genetic
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2010-08-30
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total Methadone Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: Total Methadone Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (S)- Methadone Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (S)- Methadone Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (R)-Methadone Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (R)-Methadone Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: Total EDDP Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (S)-EDDP Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (S)-EDDP Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (R)-EDDP Peak Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
measure: (R)-EDDP Trough Plasma Concentration
timeFrame: Day 1, Day 7, Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Taylorsville
country: United States
facility: Discovery House
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: John F Carlquist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlquist JF, Moody DE, Knight S, Johnson EG, Fang WB, Huntinghouse JA, Rollo JS, Webster LR, Anderson JL. A Possible Mechanistic Link Between the CYP2C19 Genotype, the Methadone Metabolite Ethylidene-1,5-Dimethyl-3,3-Diphenylpyrrolidene (EDDP), and Methadone-Induced Corrected QT Interval Prolongation in a Pilot Study. Mol Diagn Ther. 2015 Apr;19(2):131-8. doi: 10.1007/s40291-015-0137-4.