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Comparison of two different regimens of naloxone in treatment of methadone-overdosed addicted patients

Comparison of two different regimens of naloxone in treatment of methadone-overdosed addicted patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016041710133N2
Enrollment
100
Registered
2016-05-29
Start date
2015-09-23
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

Opioid Poisoning. T40

Interventions

Intervention 1: In the intervention group: administration of naloxone (Tolid Daru Company) with the initial dose of 0.04 mg increasing to 0.4- 2, and 10 mg. Intervention 2: In the control group: admin
Treatment - Drugs
In the intervention group: administration of naloxone (Tolid Daru Company) with the initial dose of 0.04 mg increasing to 0.4- 2, and 10 mg
In the control group: administration of naloxone (Tolid Daru Company) with the dose 0.1 mg every 3 minutes to reverse the signs and symptoms of methadone overdose

Sponsors

Toxicological Research Center-?Shahid Beheshti University of Medical Sciences-Vice Chancellor for Re
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Addicted methadone-overdosed patients referring; Positive signs and symptoms of methadone overdose (miosis/respiratory depression/loss of consciousness) Exclusion Criteria: Age younger than 12 years and older than 65 years; previous history of cardiovascular disease; history of respiratory complications due to naloxone; emergent situation that mandates immediate intubation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reversal of respiratory depression. Timepoint: every 3-5 minutes until reversal of the overdose signs and symptoms. Method of measurement: Check vital signs and VBG.

Secondary

MeasureTime frame
Occurence of withdrawal syndrome. Timepoint: every 5 to 10 minutes. Method of measurement: check of withdrawal signs and symptoms.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Navid Khosravi

Poisoning Ward-Loghman Hakim Hospital

khosravi.navid@gmail.com+98 21 5541 9005

Outcome results

None listed

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