Methadone Monitoring for Insights Into Adverse Events (MEMORIES)

February 28, 2017 updated by: Intermountain Health Care, Inc.
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Taylorsville, Utah, United States, 84123
        • Discovery House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Investigators

  • Principal Investigator: John F Carlquist, PhD, Intermountain Health Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 27, 2010

First Posted (ESTIMATE)

August 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 154-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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