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Comparison of naloxone and naltrexone in the treatment of methadone poisoning in patients referred to the emergency department

Comparison of naloxone and naltrexone in the treatment of methadone poisoning in patients referred to the emergency department

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016100623552N11
Enrollment
80
Registered
2016-10-18
Start date
2014-12-02
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

Poisoning by methadone.

Interventions

Intervention 1: Group 1: 3.2, which causes the patient's consciousness was embroidered in the first hour, 3/2 × 3/2 initial dose in the second hour, 3/2 × 3/2 × 3/2 initial dose in the third hour and
Treatment - Drugs
Group 1: 3.2, which causes the patient's consciousness was embroidered in the first hour, 3/2 × 3/2 initial dose in the second hour, 3/2 × 3/2 × 3/2 initial dose in the third hour and 3 / 2 × 3/2 × 3/
Group 2: equivalent dose of naloxone that consciousness is, in the form of Naltrexone receiving oral form.

Sponsors

Vice Chancellor for research of Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 20 to 60 years, obtaining informed consent from a parent or guardian patients into the study. Exclusion criteria: drug, pregnancy and breastfeeding, history of uncontrolled systemic underlying disease, especially liver disease (liver failure, hepatitis, etc.), cardiovascular disease and heart rhythm, especially supraventricular dysrhythmias ; at the same time multiple trauma, especially trauma to the head and the possibility of increased ICP; a history of seizures; a history of hypersensitivity to naloxone or naltrexone consumption in the past; recent use of narcotic analgesics, complications during the administration of a drug abuser

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Level of consciousness. Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Increasing the level of consciousness.;Respiratory function. Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Improve respiratory function.

Secondary

MeasureTime frame
The number of heart beats per minute. Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Measurable clinical responses.;Respiratory rate. Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Measurable clinical responses.;Body temperature (° C). Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Measurable clinical responses.;Systolic and diastolic blood pressure. Timepoint: 1, 2, 3, 4 and 12 hours after intervention. Method of measurement: Measurable clinical responses.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Abolfazl Jokar

Arak University of Medical sceinces

dr.a.jokar@gmail.com; rahenorayaneh@yahoo.com+98 86 3417 3517

Outcome results

None listed

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