Health Condition 1: null- Patients of opioid dependence syndrome according to ICD- 10 criteria and coming to NDDTC for treatment
Conditions
Interventions
Intervention1: Tablet Methadone 5/10mg: Methadone is a well-established pharmacological agent for management of opioid dependence. In this study, patients suffering from Opioid Dependence Syndrome wil
Sponsors
NDDTC AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria for Cases: Male patients between 18 and 60 years of age Diagnosis of opioid dependence syndrome according to ICD- 10 criteria Dependent on Heroin (any route) or Injection Buprenorphine or Injection Pentazocine Should have taken last dose of any opioid within 48 hrs of admission Subject willing to give written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria for Cases: Dependence on any other substance except Nicotine Exposure to either Buprenorphine or Methadone for treatment in preceding 3 months (either detoxification or maintenance) Admission to any facility within last 3 month Patients requiring other psychotropic medicines (like Benzodiazepines, TCAs, etc.) which can suppress symptoms of opioid withdrawal except hypnotic purposes Patients on other medications which can significantly affect serum levels of Buprenorphine or Methadone either prior to admission or during admission Any known medical contraindication to either medications Co-morbid psychiatric illness Patients previously randomized for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare oral Methadone with sublingual Buprenorphine in treatment of acute opioid withdrawal in terms of proportion of subjects completing in-patient treatment regimenTimepoint: Baseline, Day 1-10, followed by observation for 72 hrs after completion of treatment regimen | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? To assess the effect of oral Methadone on duration and severity of signs and symptoms of withdrawal and patient self-rating of opioid craving â?? To compare Methadone and Buprenorphine in terms of duration of treatment required to complete acute opioid withdrawal management, additional dosage and medicines required, and side-effects reportedTimepoint: Baseline, Day 1-10, followed by observation for 72 hrs after completion of treatment regimen | — |
Countries
India
Contacts
Public ContactDr Anil Singh Shekhawat
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed