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A Study to Compare the Blood Levels of Buprenorphine (Medication for opioid dependence) when injected or given as tablet to the psychological effects experienced in Opioid Dependent Participants.

Comparative Analysis of Plasma Levels and Subjective Effects of Intravenous vs Sublingual Buprenorphine: A Randomized, Double-Blind, Double Dummy Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077742
Enrollment
10
Registered
2024-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: ARM 1. Active Injection + Placebo Sublingual: The Intervention involves a one-time administration of Intravenous 2 mg buprenorphine/4 ml as bolus in visible upper limb vein + 2 placebo

Sponsors

Anjali Yadav
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: As per ICD 11 criteria, Patients Diagnosed with Opioid Dependence will be included in the study. The patient should be admitted to NDDTC for the treatment of opioid dependence. Patients should have: 1. History of opioid use for more than 2 years. 2. History of injecting opioid use for at least one year with the last injection within last three months.

Exclusion criteria

Exclusion criteria: The following patients will be excluded from the study: 1. Patients with current dependence on substances other than opioids (except nicotine) 2. Patients with the use of any psychoactive substance (except opioids, nicotine, medications except CNS depressants) within the last 72 hours 3. Patients with any active general medical illnesses or neurological disorder, psychiatric illnesses or disability hampering communication / informed consent process (clinically assessed)/ Experiment

Design outcomes

Primary

MeasureTime frame
1. Plasma Levels 2. Subjective effects scalesTimepoint: 7 hours

Secondary

MeasureTime frame
Comparing Plasma levels of Buprenorphine with subjective effectsTimepoint: 3 hours

Countries

India

Contacts

Public ContactAnjali Yadav

National Drug Dependence Treatment Centre(NDDTC), All India Institute of Medical Sciences, New Delhi

atul.ambekar@gmail.com

Outcome results

None listed

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