Naloxone Methadone Combination (NAMEKO)
This study is not yet open for participant recruitment.
Verified September 2012 by Kuopio University Hospital
Sponsor:
Kuopio University Hospital
Information provided by (Responsible Party):
Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01160432
First received: July 9, 2010
Last updated: September 26, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Opiate Dependence |
Drug: Methadone, naloxone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment |
Resource links provided by NLM:
Further study details as provided by Kuopio University Hospital:
Primary Outcome Measures:
- Withdrawal symptoms (Clinical Opioid Withdrawal Scale COWS, Subjective Opiate Withdrawal Scale SOWS) [ Time Frame: 1/2 hours after the first intake of medicine every week ] [ Designated as safety issue: Yes ]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) [ Time Frame: Before study begins, after 4 week study period and 4 weeks after the end of the clinical phase. ] [ Designated as safety issue: No ]Structured interview designed to measure the effectiveness and outcomes of opioid substitution treatment.
| Estimated Enrollment: | 8 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Methadone naloxone combination product 2/0,04 mg/ml
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
|
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.
Other Name: Methadone Martindale Pharma
|
|
Active Comparator: Methadone 2 mg/ml
Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
|
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.
Other Name: Methadone Martindale Pharma
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01160432
Contacts
| Contact: Ulrich Tacle, MD, PhD | +358 403553999 | ulrich.tacke@kuh.fi |
Locations
| Finland | |
| Kuopio University Hospital | Not yet recruiting |
| Kuopio, Finland, 70211 | |
| Contact: Hannu Pentikäinen, MD +358 17173095 hannu.pentikainen@kuh.fi | |
| Sub-Investigator: Hanna Uosukainen, MSci (Pharm) | |
Sponsors and Collaborators
Kuopio University Hospital
Investigators
| Study Director: | Ulrich Tacke, MD, PhD | Kuopio University Hospital, University of Eastern Finland |
More Information
No publications provided
| Responsible Party: | Ulrich Tacke, MD, PhD, docent, Kuopio University Hospital |
| ClinicalTrials.gov Identifier: | NCT01160432 History of Changes |
| Other Study ID Numbers: | KUH5703433, 2010-021814-43 |
| Study First Received: | July 9, 2010 |
| Last Updated: | September 26, 2012 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by Kuopio University Hospital:
|
opiate dependence methadone naloxone withdrawal symptom substitution treatment |
Additional relevant MeSH terms:
|
Methadone Opioid-Related Disorders Substance-Related Disorders Mental Disorders Naloxone Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Narcotic Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013