Clinical trial

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

NCT04254731

Name

2012/793 REK

Description

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

Trial arms

Trial start

2015-05-07

Estimated PCD

2018-06-27

Trial end

2024-07-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Same individuals treated with racemic methadone and switched to levomethadone (R-methadone)

Arms:

Cross over study before and after drug switch

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

Size

Primary endpoint

Effects of switching from racemic methadone to R-methadone on serum methadone concentrations.

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 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 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 of each patient form inclusion to end study was 35-40 days.

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients included were stabilized on per os methadone maintenance treatment and had automatically ECG recorded QTc interval greater or equal to 450 ms. The patients were switched to pure R-methadone per os (half dose of the racemic methadone used). Doses, serum drug concentrations, QTc-time were recorded before and after drug switch. Serum-electrolytes (Mg, K, Ca) and opioid withdrawal symptom scale (OWS) were also measured and scored before and after drug switch.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

Updated at

2024-04-03

1 organization

1 product

3 indications

Organization

Oslo University Hospital

Product

Indication

Indication

Indication