N/A
Completed N=31
Methadone Monitoring for Insights Into Adverse Events
Postoperative Pain · Opiate Addiction
Source: ClinicalTrials.gov NCT01191242 ↗
Enrolled (actual)
31
Serious AEs
—
Results posted
Feb 2017
Primary outcomePrimary: Total Methadone Peak Plasma Concentration — 107.3; 315.4; 362.2 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Methadone Peak Plasma Concentration |
107.3; 315.4; 362.2 | — |
| PRIMARY Total Methadone Trough Plasma Concentration |
53.0; 162.6; 211.1 | — |
| PRIMARY (S)- Methadone Peak Plasma Concentration |
65.6; 178.8; 215.1 | — |
| PRIMARY (S)- Methadone Trough Plasma Concentration |
32.2; 84.2; 106.1 | — |
| PRIMARY (R)-Methadone Peak Plasma Concentration |
41.8; 136.6; 178.6 | — |
| PRIMARY (R)-Methadone Trough Plasma Concentration |
23.0; 78.4; 105.0 | — |
| PRIMARY Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration |
11.0; 39.8; 45.3 | — |
| PRIMARY Total EDDP Trough Plasma Concentration |
4.8; 17.7; 26.6 | — |
| PRIMARY (S)-EDDP Peak Plasma Concentration |
5.8; 20.6; 30.3 | — |
| PRIMARY (S)-EDDP Trough Plasma Concentration |
3.8; 9.1; 13.7 | — |
| PRIMARY (R)-EDDP Peak Plasma Concentration |
3.4; 13.5; 18.2 | — |
| PRIMARY (R)-EDDP Trough Plasma Concentration |
1.2; 6.6; 10.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01191242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.