Naloxone Methadone Combination (NAMEKO)

Opiate Dependence Clinical Trial

— NAMEKO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01160432
• Other study ID #: KUH5703433
• Secondary ID: 2010-021814-43
• Status: Withdrawn
• Phase: N/A
• First received: July 9, 2010
• Last updated: July 3, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Methadone, 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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	No