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Methadone Monitoring for Insights Into Adverse Events (MEMORIES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191242
First Posted: August 30, 2010
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
  Purpose
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.

Condition
Pain Opiate Addiction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Methadone Monitoring for Insights Into Adverse Events

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Total Methadone Peak Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • Total Methadone Trough Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (S)- Methadone Peak Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (S)- Methadone Trough Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (R)-Methadone Peak Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (R)-Methadone Trough Plasma Concentration [ Time Frame: 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 ]
  • Total EDDP Trough Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (S)-EDDP Peak Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (S)-EDDP Trough Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (R)-EDDP Peak Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]
  • (R)-EDDP Trough Plasma Concentration [ Time Frame: Day 1, Day 7, Day 21 ]

Biospecimen Retention:   Samples With DNA
Plasma and DNA

Enrollment: 31
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects initiating methadone treatment for opioid addiction who meet elibitility criteria.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191242


Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
Discovery House
Taylorsville, Utah, United States, 84123
Sponsors and Collaborators
Intermountain Health Care, Inc.
Investigators
Principal Investigator: John F Carlquist, PhD Intermountain Health Care, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01191242     History of Changes
Other Study ID Numbers: 154-08
First Submitted: August 17, 2010
First Posted: August 30, 2010
Results First Submitted: December 21, 2016
Results First Posted: February 17, 2017
Last Update Posted: March 29, 2017
Last Verified: April 2012

Keywords provided by Intermountain Health Care, Inc.:
methadone
genetic

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents