Naloxone Methadone Combination (NAMEKO)

• Status: Withdrawn
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuopio University Hospital
• Treatments: Methadone; Naloxone

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