Effects of Switching From Racemic Methadone to R-methadone on QTc Intervals
NCT ID: NCT04254731
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
10 participants
INTERVENTIONAL
2015-05-07
2024-07-30
Brief Summary
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Detailed Description
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The investigators hypothesized that switching from racemic to R-methadone would reduce the methadone serum concentration and also its effect on the QTc interval.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Same individuals treated with racemic methadone and switched to levomethadone (R-methadone)
Interventions
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Same individuals treated with racemic methadone and switched to levomethadone (R-methadone)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Serious psychiatric disease
* Untreated serious somatic disease
* Pregnancy
18 Years
70 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Mimi Stokke Opdal
Senior Consultant and Associate Professor of Clinical Pharmacology
Principal Investigators
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Mimi Stokke S Opdal, MD, PhD
Role: STUDY_DIRECTOR
Oslo University Hospital and University of Oslo
Peter Krajci, MD, PhD
Role: STUDY_DIRECTOR
Oslo University Hospital
Locations
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Department of Pharmacology , Oslo University Hospital
Oslo, , Norway
Department of Pharmacology and Department of Substance Use Disorder, Oslo University Hospital
Oslo, , Norway
Department of Substance Use Disorder, Oslo University Hospital
Oslo, , Norway
Countries
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References
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Havig SM, Berg-Pedersen RM, Krabseth HM, Muller LD, Haugaa K, Zare HK, Gjesdal K, Krajci P, Opdal MS. Effect on QTc interval by switching from methadone to equipotent R-methadone dose in methadone maintenance treatment patients. Basic Clin Pharmacol Toxicol. 2024 Apr;134(4):519-530. doi: 10.1111/bcpt.13982. Epub 2024 Feb 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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abstract from EACPT 2019, see abstract 1168
Other Identifiers
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2012/793 REK
Identifier Type: -
Identifier Source: org_study_id
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