Naloxone Methadone Combination (NAMEKO)

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01160432

Acronym

NAMEKO

Enrollment

Registered

2010-07-12

Start date

2013-05-31

Completion date

2013-07-31

Last updated

2013-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependence

Keywords

opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment

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.

Interventions

DRUGMethadone, naloxone

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026