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Intramuscular Naloxone in methadone overdose

??The effect of intramuscular naloxone in comparison with intravenous naloxone inpatients with methadone overdose, a randomized clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120629010133N6
Enrollment
398
Registered
2023-01-01
Start date
2023-01-20
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

methadone. Poisoning by, adverse effect of and underdosing of methadone

Interventions

Intervention 1: Intervention group: Intramuscular injection of naloxone would be calculated every 4 hours based on the calculation for I.V. naloxone: If the calculated dose is less than 0.2 mg/h, the

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: methadone overdose as the main substance age>=18 age<=60 no background diseases response to naloxone in initial try opioid dependent

Exclusion criteria

Exclusion criteria: no informed consent

Design outcomes

Primary

MeasureTime frame
Renarcosis. Timepoint: On-arrival blood gas analysis and then each 4 hours. Method of measurement: Blood gas.;Withdrawal syndrome. Timepoint: On-arrival band then each 4 hours. Method of measurement: Evaluation of COWS scale.;Need for naloxone. Timepoint: Each hour. Method of measurement: Blood gasometery, reduced respiratory rate, Apnea.;Need for intubation. Timepoint: hourly. Method of measurement: Clinical and laboratory indications for intubation.

Secondary

MeasureTime frame
Hospitalization period. Timepoint: End of hospitalization. Method of measurement: Days of hospitalization.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Hassanian-Moghaddam

Shahid Beheshti University of Medical Sciences

hassanian@sbmu.ac.ir+98 21 5540 9534

Outcome results

None listed

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