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Naloxone Methadone Combination (NAMEKO)

NCT01160432 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-07-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Ulrich Tacke, MD, PhD · Kuopio University Hospital, University of Eastern Finland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160432 on ClinicalTrials.gov