A total of 70 non-addicted patients who have referred with methadone overdose will randomly be assigned into either A or B groups receiving 100 or 50 mg of naltrexone capsules. The patients will firstly be evaluated by narcan challenge test to be sure that they are not addicted. 0.2- mg, 0.6-mg, and 1.2-mg narcan doses are administered. If the patients do not develop signs and symptoms of withdrawal, they are considered to be opioid-naive and receive the naltrexone capsules. All patients, researchers and data collectors will be blind to the dose of naltrexone administered. They will be followed for 24 hours for possible reversal of signs and symptoms of opioid overdose (apnea/bradypnea/cyanosis/respiratory acidosis). After 24 hours, they will be discharged and followed later by phone calls. The two groups will finally be compared regarding the occurrence of complications and mortality to determine the best dose of naltrexone in prevention of the opioid syndrome reversal.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603083913N2
Registration date:2016-05-23, 1395/03/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-23, 1395/03/03
Registrant information
Name
Shahin Shadnia
Name of organization / entity
Shaheed Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
shadniatrc@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Toxicological Research Center- Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 50 - and 100 - mg doses of Naltrexone in controlling apnea and bradypnea in non-addicted patients overdosed with methadone
Public title
Comparison of 50 - and 100 - mg doses of Naltrexone in controlling apnea and bradypnea in non-addicted patients overdosed with methadone
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 12 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee; Shahid Beheshti University of Medical Sciencse
Street address
Shahid Beheshti University of Medical Sciencse
City
Tehran
Postal code
NA
Approval date
2016-02-10, 1394/11/21
Ethics committee reference number
IR.SBMU.RAM.REC.1394.531
Health conditions studied
1
Description of health condition studied
Non-addicted patients overdosed with methadone
ICD-10 code
T40.3
ICD-10 code description
Methadone
Primary outcomes
1
Description
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 outcomes
1
Description
Control of the respiratory acidosis
Timepoint
twice in 24 hours
Method of measurement
interpretation of the patients' ABG
Intervention groups
1
Description
Capsule Naltrexone 100 mg,Oral,single dose
Category
Treatment - Drugs
2
Description
Capsule Naltrexone 50 mg,Oral,single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Dr Ali Ostadi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Toxicological Research Center
Full name of responsible person
Mrs Morsali
Street address
Loghman Hakim Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Toxicological Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ali Ostadi
Position
Fellowship of clinical toxicology
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4041
Fax
Email
ostadi85@yahoo.com; ostadia@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Shahin Shadnia
Position
Full Professor
Other areas of specialty/work
Street address
Loghman Hakim Hopsital
City
Tehran
Postal code
00982155424041
Phone
+98 21 5542 4041
Fax
Email
shahin1380@yahoo.com; shahin 1380@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ali Ostadi
Position
Fellowship of Clinical Toxicology
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4041
Fax
Email
ostadi85@yahoo.com; ostadia@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)