Naloxone Methadone Combination (NAMEKO)

Not Applicable

Withdrawn

• Conditions: Opiate Dependence
• Interventions: Drug: Methadone, naloxone

• Registration Number: NCT01160432
• Lead Sponsor: Kuopio University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-12
• Study Start: 2013-05
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-03
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Methadone naloxone combination product 2/0,04 mg/ml	Methadone, naloxone	Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
Methadone 2 mg/ml	Methadone, naloxone	Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).

Primary Outcome Measures

Name	Time	Method
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)	1/2 hours after the first intake of medicine every week	COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).

Secondary Outcome Measures

Name	Time	Method
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.	Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland