Back to resultsNaloxone Methadone Combination (NAMEKO) (NAMEKO)
Primary Purpose
Opiate Dependence
Status
Withdrawn
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Methadone, naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment
Eligibility 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
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methadone naloxone combination product 2/0,04 mg/ml
Methadone 2 mg/ml
Arm Description
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01160432
Brief Title
Naloxone Methadone Combination (NAMEKO)
Acronym
NAMEKO
Official Title
The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opiate dependence, methadone, naloxone, withdrawal symptom, substitution treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone naloxone combination product 2/0,04 mg/ml
Arm Type
Experimental
Arm Description
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
Arm Title
Methadone 2 mg/ml
Arm Type
Active Comparator
Arm Description
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
Intervention Type
Drug
Intervention Name(s)
Methadone, naloxone
Other Intervention Name(s)
Methadone Martindale Pharma
Intervention Description
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.
Primary Outcome Measure Information:
Title
Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS)
Description
COWS is completed by the nurse and SOWS by the patient. Withdrawal symptoms are estimated every week after the intake of new product (blinded).
Time Frame
1/2 hours after the first intake of medicine every week
Secondary Outcome Measure Information:
Title
The effectiveness of treatment (Treatment Outcomes Profile TOP)
Description
Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
Time Frame
Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Tacke, MD, PhD
Organizational Affiliation
Kuopio University Hospital, University of Eastern Finland
Official's Role
Study Director
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Naloxone Methadone Combination (NAMEKO)
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