Naloxone Methadone Combination (NAMEKO)

Kuopio University Hospital

Status: Withdrawn

Conditions: Opiate Dependence

Treatments: Drug: Methadone, naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT01160432

2010-021814-43 (EudraCT Number)

KUH5703433

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Methadone naloxone combination product 2/0,04 mg/ml

Experimental group

Description:

Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml

Treatment:

Drug: Methadone, naloxone

Methadone 2 mg/ml

Active Comparator group

Description:

Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).

Treatment:

Drug: Methadone, naloxone