Naloxone Methadone Combination (NAMEKO) (NAMEKO)

July 3, 2013 updated by: Ulrich Tacke, Kuopio University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • Finland
      • Kuopio, Finland, 70211
        • Kuopio 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • opioid dependence
  • methadone treatment
  • no changes in methadone dose during the last 10 days
  • good treatment compliance according to doctor
  • normal ALAT and AFOS values (increased if double the normal level)

Exclusion Criteria:

  • severe renal or hepatic failure
  • acute psychosis
  • age under 18
  • pregnancy
  • legal incompetence
  • severe somatic disease
  • chaotic situation in life
  • medication or disease which is contraindication to study treatment

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone naloxone combination product 2/0,04 mg/ml
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
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.
Other Names:
  • Methadone Martindale Pharma
Active Comparator: Methadone 2 mg/ml
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
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.
Other Names:
  • Methadone Martindale Pharma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
Time Frame: 1/2 hours after the first intake of medicine every week
COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).
1/2 hours after the first intake of medicine every week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Time Frame: Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.

Collaborators and Investigators

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

Sponsor

Kuopio University Hospital

Investigators

  • Study Director: Ulrich Tacke, MD, PhD, Kuopio University Hospital, University of Eastern Finland

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

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 9, 2010

First Posted (Estimate)

July 12, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5703433
  • 2010-021814-43 (EudraCT Number)

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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