Effects of Switching From Racemic Methadone to R-methadone on QTc Intervals (MePhaCard)

April 2, 2024 updated by: Mimi Stokke Opdal, Oslo University Hospital

The Study of Potential Normalization of Cardiac Rhythm Following Drug Exchange From Chimeric Methadone to Active Methadone

Effects of switching from racemic methadone to R-methadone on serum methadone concentrations and QTc intervals

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Racemic methadone may prolong the QTc interval, which is associated with fatal arrhythmias. In vitro studies have shown that R-methadone has less inhibitory effect than S-methadone on the voltage-gated potassium channel current, and is thus thought to have less effect on the QTc interval.

The investigators hypothesized that switching from racemic to R-methadone would reduce the methadone serum concentration and also its effect on the QTc interval.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

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

  • Norway
      • Oslo, Norway, 0424
        • Department of Pharmacology , Oslo University Hospital
      • Oslo, Norway, 0424
        • Department of Pharmacology and Department of Substance Use Disorder, Oslo University Hospital
      • Oslo, Norway, 0424
        • Department of Substance Use Disorder, Oslo University Hospital

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stabilized on daily methadone dose
  • Not using other drugs of abuse
  • QTc-time recorded automatically, patient inclusion if QTc interval was greater or equal to 450 ms
  • Older than 18 years
  • Can sign and understand a written Consent

Exclusion Criteria:

  • Can not cooperate regarding observed daily drug intake
  • Serious psychiatric disease
  • Untreated serious somatic disease
  • Pregnancy

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cross over study before and after drug switch
Stabilized on racemic methadone dose, switched to R-methadone of half racemic methadone dose. Cross over study, own control
Drug: Same individuals treated with racemic methadone and switched to levomethadone (R-methadone)
Other Names:
  • Drugs provided from the pharmaceutical company called DnePharma AS (Den norske Eterfabrikk ( DnE), address Karihaugen 22, Oslo, Norway, drug delivered to patient from home nurse or pharmacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of switching from racemic methadone to R-methadone on serum methadone concentrations.
Time Frame: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients stabilized on racemic methadone dose were switched to R-methadone and effects on serum methadone concentrations were studied. Methadone concentrations (nmol/L) were measured by validated high pressure liquid chromatography coupled to mass spectrometry detection (LC-MSMS).
Time frame of each patient form inclusion to end study was 35-40 days.
Effects of switching from racemic methadone to R-methadone on QTc interval
Time Frame: Time frame of each patient form inclusion to end study was 35-40 days.
In ten patients QTc intervals were recorded on racemic methadone treatment at Cmin and Cmax of methadone drug concentrations and likewise after the shift to R-methadone. QT intervals (ms) on ECG were recorded automatically and read manually by experienced cardiologists.
Time frame of each patient form inclusion to end study was 35-40 days.
Effects of switching from racemic methadone to R-methadone on opioid withdrawal symptoms (OWS)
Time Frame: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients: each patients had OWS recorded on racemic and R-methadone treatment using OWS.
Time frame of each patient form inclusion to end study was 35-40 days.
Effects of switching from racemic methadone to R-methadone, stability of serum electrolytes (Ca, Mg, K) in patients
Time Frame: Time frame of each patient form inclusion to end study was 35-40 days.
Ten patients: samples for serum electrolytes were collected before and after switch to R-methadone. Measured by routine analysis at Cobas 8000 (unit mmol/L)
Time frame of each patient form inclusion to end study was 35-40 days.

Collaborators and Investigators

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

Sponsor

Oslo University Hospital

Investigators

  • Study Director: Mimi Stokke S Opdal, MD, PhD, Oslo University Hospital and University of Oslo
  • Study Director: Peter Krajci, MD, PhD, Oslo University Hospital

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

Helpful Links

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 (Actual)

May 7, 2015

Primary Completion (Actual)

June 27, 2018

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

January 6, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/793 REK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD can be shared when the manuscript has been accepted for publication.

IPD Sharing Time Frame

Protocol in Norwegian attached

IPD Sharing Access Criteria

IPD proving the results of the different outcome measures will be shared, see above

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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