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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
Kuopio University Hospital
Kuopio, Finland
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 platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.