Naloxone Methadone Combination (NAMEKO)

Study Overview
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Brief Summary
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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.

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

Conditions
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Opiate Dependence

Intervention / Treatment
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* Drug: Methadone, naloxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methadone naloxone combination product 2/0,04 mg/ml<br>Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml | Drug: Methadone, naloxone<br>* 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.<br>* Other names: Methadone Martindale Pharma;|
| Active Comparator: Methadone 2 mg/ml<br>Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml). | Drug: Methadone, naloxone<br>* 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.<br>* Other names: Methadone Martindale Pharma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of treatment (Treatment Outcomes Profile TOP) | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment