Methadone Monitoring for Insights Into Adverse Events

Pain Clinical Trial

— MEMORIES  

Official title:

Methadone Monitoring for Insights Into Adverse Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01191242
• Other study ID #: 154-08
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: April 4, 2012
• Start date: August 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2012
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Opiate Addiction
• Pain

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Discovery House	Taylorsville	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma methadone/EDDP ratio		days 1, 7 following methadone initiation and whenand when stabledosing is achieved at an average of 21 days	No
Secondary	QT interval prolongation		at the time of stable dose at an average of 21 days	No