NCT01160432

Naloxone Methadone Combination (NAMEKO)

The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kuopio University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to examine the tolerability and abuse potential of the diluted methadone solution (5 mg/ml → 2 mg/ml) in combination with naloxone in opioid substitution treatment. Study hypothesis: Treatment with this diluted combination product is safer than with methadone alone (5 mg/ml) and combination product does not precipitate withdrawal symptoms in opioid dependent patients.

Conditions

• Opiate Dependence

Interventions

Type	Name	Description
DRUG	Methadone, naloxone	Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml daily according to patient's individual dose. At first open label pilot using single (individual) dosage for 2 patients. After that crossover study using methadone 2 mg/ml in combination with naloxone 0,04 mg/ml compared to methadone 2 mg/ml alone in one week's periods for four weeks.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-07-12
• Last updated: 2013-07-04

Locations

1 site across 1 country: Finland