Health Condition 1: null- Opioid dependence
Conditions
Interventions
Intervention1: Buprenorphine: Group 1- buprenorphine 1.2mg/day sublingually in 3 divided doses.
Group 2- Buprenorphine 2.4 mg/day sublingually in 3 divided doses for 14 days
Control Intervention1: Tab
Sponsors
Government Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.) Male subjects of age 18-60 years. 2.) Patient should be willing for admission. 3.) Patient willing to give urine sample for opioid screening on demand. 4.) In case of co morbid mental disorder patient should be clinically stable i.e. there has been no change in medication or increase in dose by 50% in last 3 month. 5.) Patient willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1.) Patient with co morbid medical/surgical illness in which clonidine and buprenorphine is contraindicated. 2.) Patient with other substance dependence except for nicotine or caffeine. 3.) Patient with evidence of sub-normal intelligence or active major mental disorder which cause cognitive decline. 4.) Subjects who have been on opioid maintenance. 5.) Subjects reporting after 48 hours of last use of opioid. 6.) Actively suicidal patient. 7.) History of any adverse drug reaction with buprenorphine and clonidine in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemogram,Renal Function Test, Liver Function Test Electrocardiogram (ECG) Addiction Severity Index (ASI) Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A). Objective Opioid Withdrawal Scale Subjective Opiate Withdrawal Scale Visual Analogue Scale ( VAS ) Urine screening for opioid Timepoint: Haemogram,Renal Function Test, Liver Function Test Electrocardiogram (ECG) Addiction Severity Index (ASI) Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES 8A). Objective Opioid Withdrawal Scale Subjective Opiate Withdrawal Scale Visual Analogue Scale ( VAS ) Urine screening for opioid | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Opioid Withdrawal Scale for opioid Subjective Opiate Withdrawal Scale for opioid Visual Analogue Scale Checklist for side effects of clonidine and buprenorphine Random : urine screening for opioid detection Timepoint: day 2,3,4,5,6,7,8,9,10,11,12,13 and day 14th. | — |
Countries
India
Contacts
Public ContactDrBSChavan
Government Medical College Hospital
Outcome results
None listed