Naloxone Methadone Combination (NAMEKO)
NAMEKO
The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
2 other identifiers
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 12, 2010
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 4, 2013
July 1, 2013
2 months
July 9, 2010
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
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 Outcomes (1)
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
Study Arms (2)
Methadone naloxone combination product 2/0,04 mg/ml
EXPERIMENTALMethadone 2 mg/ml in combination with naloxone 0,04 mg/ml
Methadone 2 mg/ml
ACTIVE COMPARATORNormal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kuopio University Hospital
Kuopio, 70211, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ulrich Tacke, MD, PhD
Kuopio University Hospital, University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, docent
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 12, 2010
Study Start
May 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 4, 2013
Record last verified: 2013-07