Methadone Monitoring for Insights Into Adverse Events

Completed

• Conditions: Opiate Addiction; Pain

• Registration Number: NCT01191242
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-27
• Study First Posted: 2010-08-30
• Primary Completion: 2011-03
• Study Completion: 2011-05
• Status Verified: 2012-04
• Results First Submitted: 2016-12-21
• Results First Submitted QC: 2016-12-21
• Results First Posted: 2017-02-17
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total Methadone Peak Plasma Concentration	Day 1, Day 7, Day 21
(S)- Methadone Peak Plasma Concentration	Day 1, Day 7, Day 21
(R)-Methadone Peak Plasma Concentration	Day 1, Day 7, Day 21
(R)-Methadone Trough Plasma Concentration	Day 1, Day 7, Day 21
(S)-EDDP Peak Plasma Concentration	Day 1, Day 7, Day 21
(R)-EDDP Peak Plasma Concentration	Day 1, Day 7, Day 21
Total Methadone Trough Plasma Concentration	Day 1, Day 7, Day 21
(R)-EDDP Trough Plasma Concentration	Day 1, Day 7, Day 21
(S)- Methadone Trough Plasma Concentration	Day 1, Day 7, Day 21
Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration	Day 1, Day 7, Day 21
Total EDDP Trough Plasma Concentration	Day 1, Day 7, Day 21
(S)-EDDP Trough Plasma Concentration	Day 1, Day 7, Day 21

Trial Locations

Locations (2)

Discovery House; 🇺🇸 Taylorsville, Utah, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States