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A study to find out the amount of Naloxone which is required to effectively block the addictive effects of Buprenorphine when administered intravenously.

Effect of Concurrent Administration of Intravenous Naloxone on Opioid Agonist Effects of Intravenous Buprenorphine: A Double-blind, Within-subject, Randomized, Cross-over Study among Opioid Dependent Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008817
Enrollment
12
Registered
2017-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients of Opioid Dependence seeking treatment from NDDTC, AIIMS

Interventions

Intervention1: Inj Buprenorphine 2mg with Inj Naloxone 0.5mg: This is one of the intervention contains Injection Buprenorphine 2mg and Injection Naloxone 0.5mg that is 4:1 combination along with norma

Sponsors

National Drug Dependence Treatment Centre AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

India

Contacts

Public ContactNaveen kumar Dhagudu

All India Institute of Medical Sciences (AIIMS), New Delhi

naveendhagudu@gmail.com9247266680

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026