An interventional study of Methadone, naloxone in Opiate Dependence, sponsored by Kuopio University Hospital. Withdrawn at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-07-04.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and 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.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml
Drug: Methadone, naloxone
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.
Also known as: Methadone Martindale Pharma
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).
Time frame: 1/2 hours after the first intake of medicine every week
The effectiveness of treatment (Treatment Outcomes Profile TOP)
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.
This study is withdrawn, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital