Naloxone Methadone Combination (NAMEKO)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01160432
First received: July 9, 2010
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Opiate Dependence
Drug: Methadone, naloxone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.


Enrollment: 0
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Methadone Martindale Pharma

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160432

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Sponsors and Collaborators
Kuopio University Hospital
Investigators
Study Director: Ulrich Tacke, MD, PhD Kuopio University Hospital, University of Eastern Finland
  More Information

No publications provided

Responsible Party: Ulrich Tacke, MD, PhD, docent, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01160432     History of Changes
Other Study ID Numbers: KUH5703433, 2010-021814-43
Study First Received: July 9, 2010
Last Updated: July 3, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Kuopio University Hospital:
opiate dependence
methadone
naloxone
withdrawal symptom
substitution treatment

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014