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The role of naltrexone in opioid toxicity

The efficacy of oral naltrexone to maintain normal ventilation after acute methadone Poisoning in Opioid non-dependent Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2012062910133N1
Enrollment
60
Registered
2013-03-22
Start date
2012-11-20
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

Acute Opioids Toxicity. Mental and behavioural disorders due to use of opioids

Interventions

After emergency management (if needed) the patients in intervention group will take a single dose of 50mg naltrexone orally . During the hospital stay, the prevalence of respiratory depression or resp
The patients in control group after emergency management (if needed) will take a placebo drug. These patient during hospital admission will monitor regarding to respiratory depression or arrest and lo
Treatment - Drugs
Intervention group
Control group

Sponsors

Loghman-Hakim Toxicological Reserch Center dependent to Shahid-Beheshti University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: The acutely methadone-poisoned patients ;opioid non-dependent patients; Exclusion criteria: The addicted patients (Opioid-dependent patients); Active liver disease; Acute methadone poisoning with development of complications (aspiration pneumonia, brain trauma, and cardiogenic or non-cardiogenic pulmonary edema); History of acute coronory syndrome in last 3 weeks

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Oxygenation (Arterial Blood Oxygen Saturation in Percent). Timepoint: Continuously up to 48 hours. Method of measurement: Pulseoxymetery.;Ventilation status. Timepoint: every 6 hours up to 48 hours. Method of measurement: Arterial or venous blood gas.;Hospital Stay. Timepoint: Hours. Method of measurement: Based on registration of time and date on medical file.;Acute Complications. Timepoint: Up to 48 hours. Method of measurement: Physical Examination, inspection and paraclinic data.;Respiratory rate per minute. Timepoint: hour to hour up to 48 hours. Method of measurement: physical examination and inspection.

Secondary

MeasureTime frame
Level of Consciousness. Timepoint: hour to hour Up to 48 hours. Method of measurement: Physical Examination and assessment of neurologic system.;Need to naloxone. Timepoint: During 48 hrs admission. Method of measurement: Dose of Naloxone Received (mg).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosein Hassanian-Moghaddam

Shahid Beheshti University of Medical Sciences

hassanian@sbmu.ac.ir/hasanian2000@yahoo.comaghabikloo@yahoo.com+98 21 5540 9534

Outcome results

None listed

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