- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01160432
Naloxone Methadone Combination (NAMEKO) (NAMEKO)
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
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kuopio, Finland, 70211
- Kuopio University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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:
|
Active Comparator: Methadone 2 mg/ml
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
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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:
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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
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COWS is completed by the nurse and SOWS by the patient.
Withdrawal symptoms are estimated every week after the intake of new product (blinded).
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1/2 hours after the first intake of medicine every week
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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.
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Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
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Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ulrich Tacke, MD, PhD, Kuopio University Hospital, University of Eastern Finland
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Respiratory System Agents
- Antitussive Agents
- Naloxone
- Methadone
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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