A study to find out the amount of Naloxone which is required to effectively block the addictive effects of Buprenorphine when administered intravenously.
- Conditions
- Health Condition 1: null- Patients of Opioid Dependence seeking treatment from NDDTC, AIIMS
- Registration Number
- CTRI/2017/06/008817
- Lead Sponsor
- ational Drug Dependence Treatment Centre AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1. Diagnosed patients of opioid dependence (as per ICD 10 criteria)
2. History of injecting drug use ever in life
3. Should be on sublingual buprenorphine or buprenorphine-naloxone combination tablets from NDDTC for at least 3 months
4. Maintained on sublingual buprenorphine or buprenorphine-naloxone combination dose of 8 to 18 mg per day
5. Received sublingual buprenorphine or buprenorphine-naloxone combination tablets on at least 75% of the scheduled occasions in previous three months.
6. Willing to provide informed consent
7. Able to read and write
1. Current dependence on substances other than opioids (except nicotine)
2. Use of any other psychoactive substance (except nicotine and prescribed psychotropic medications) within the last 72 hours
3. Any current general medical illnesses or neurological disorder, psychiatric illnesses or disability hampering communication / informed consent process.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of different intravenous doses of Naloxone on euphoric effect associated with intravenous administration of Buprenorphine in patients stabilized on sublingual Buprenorphine.Timepoint: 0 minutes (Pre aseessment), 5 minutes, 30 minutes, 1 hour, 2hours after the intervention.
- Secondary Outcome Measures
Name Time Method To assess for opioid withdrawals in patients stabilized on sublingual buprenorphine after intravenous administration of different ratios of buprenorphine and naloxone.Timepoint: 0 minutes (Pre aseessment), 5 minutes, 30 minutes, 1 hour, 2hours after the intervention.;To assess for other subjective experiences of craving, sedation, distress by concurrent administration of intravenous buprenorphine and naloxone among patients stabilized on sublingual buprenorphine.Timepoint: 0 minutes (Pre aseessment), 5 minutes, 30 minutes, 1 hour, 2hours after the intervention.