Skip to main content
OpenTrials
Completed

NCT Number: NCT01191242

Methadone Monitoring for Insights Into Adverse Events

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opiate Addiction Opioid-Related Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center, Murray, Utah, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Total Methadone Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  2. Total Methadone Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  3. (S)- Methadone Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  4. (S)- Methadone Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  5. (R)-Methadone Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  6. (R)-Methadone Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  7. Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  8. Total EDDP Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  9. (S)-EDDP Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  10. (S)-EDDP Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  11. (R)-EDDP Peak Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

  12. (R)-EDDP Trough Plasma Concentration

    Time frame: Day 1, Day 7, Day 21

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Acronym: MEMORIES

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.