Methadone Monitoring for Insights Into Adverse Events (MEMORIES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01191242
First received: August 17, 2010
Last updated: April 4, 2012
Last verified: April 2012
  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:
  • plasma methadone/EDDP ratio [ Time Frame: days 1, 7 following methadone initiation and whenand when stabledosing is achieved at an average of 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QT interval prolongation [ Time Frame: at the time of stable dose at an average of 21 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01191242     History of Changes
Other Study ID Numbers: 154-08
Study First Received: August 17, 2010
Last Updated: April 4, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 23, 2014