Naloxone Methadone Combination (NAMEKO)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Ulrich Tacke, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01160432
First received: July 9, 2010
Last updated: July 3, 2013
Last verified: July 2013

July 9, 2010
July 3, 2013
May 2013
July 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01160432 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Naloxone Methadone Combination (NAMEKO)
The Safety and Tolerability of Methadone/Naloxone Combination in Opioid Substitution Treatment

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opiate Dependence
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
  • Experimental: Methadone naloxone combination product 2/0,04 mg/ml
    Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
    Intervention: Drug: Methadone, naloxone
  • Active Comparator: Methadone 2 mg/ml
    Normal treatment except the dilution of methadone solution (5 mg/ml → 2 mg/ml).
    Intervention: Drug: Methadone, naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01160432
KUH5703433, 2010-021814-43
No
Ulrich Tacke, Kuopio University Hospital
Kuopio University Hospital
Not Provided
Study Director: Ulrich Tacke, MD, PhD Kuopio University Hospital, University of Eastern Finland
Kuopio University Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP