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Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study

Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015011020624N1
Enrollment
90
Registered
2015-11-27
Start date
2016-03-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Methadone Overdose. Poisoning by Methadone

Interventions

Intervention 1: Narcan Injection (case group). Intervention 2: Buprenorphine (5micro/kg
1st Control Group). Intervention 3: Buprenorphine (10micro/kg
2nd Control group).
Treatment - Drugs
Narcan Injection (case group)
Buprenorphine (5micro/kg
1st Control Group)
Buprenorphine (10micro/kg
2nd Control group)

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all opioid-dependant patients who refer after methadone overdose will be included and randomly assigned into either case (buprenorphine with two different doses) or control (naloxone) group. Exclusion criteria: 1-Those younger than 12 years of age and older than 100 years will be excluded. 2- Patients with multiple drug overdoses will be excluded. 3-Patients who do not respond to the buprenorphien and naloxone doses and are in life-treathening situation will be intubated and excluded from the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reversal of Respiratory Depression. Timepoint: 1 min. Method of measurement: reversal of respiratory rate.

Secondary

MeasureTime frame
Reversal of cyanosis and increased O2 Saturation. Timepoint: 2 minutes. Method of measurement: Pulse Oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nasim Zamani

Shahid Beheshti University of Medical Sciences

nasim.zamani@gmail.com+98 21 5542 4041

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 28, 2026