Comparison of 50 - and 100 - mg doses of Naltrexone in controlling apnea and bradypnea in non-addicted patients overdosed with methadone

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201603083913N2

Enrollment

Registered

2016-05-23

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

Non-addicted patients overdosed with methadone. Methadone

Interventions

Intervention 1: Capsule Naltrexone 100 mg,Oral,single dose. Intervention 2: Capsule Naltrexone 50 mg,Oral,single dose.

Treatment - Drugs

Capsule Naltrexone 100 mg,Oral,single dose

Capsule Naltrexone 50 mg,Oral,single dose

Eligibility

Sex/Gender

All

Age

12 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: non-addicted patients to any type of opioid who have referred with methadone overdose; existence of overdose signs and symptoms(bradypnea/apnea/miosis/loss of consciousness) Exclusion criteria: patients over 65 years and younger than 12 years of age; respiratory complications (ARDS, pulmonary edema, etc) due to narcan administration; history of cardiovascular diseases; unstable patients in whose treatment should be initiated immediately (need to be immediately intubated; general indications for intubation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Reversal of overdose signs and symptoms(bradypnea/apnea). Timepoint: 24-hour monitoring. Method of measurement: clinical evaluation of the patients (regarding vital signs and clinical manifestations).	—

Secondary

Measure	Time frame
Control of the respiratory acidosis. Timepoint: twice in 24 hours. Method of measurement: interpretation of the patients' ABG.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Ostadi

Shahid Beheshti University of Medical Sciences

ostadi85@yahoo.com; ostadia@tbzmed.ac.ir+98 21 5542 4041

Outcome results

None listed

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