The main aim is to determine the best dose of naloxone in reversal of the signs and symptoms of methadone overdose in opium-addicted patients.In this phase 2 study in Loghman Hakim hospital, patients will randomly be assigned into either intervention or control group. The 50 patients in the intervention group receive naloxone with dose of 0.04 mg increasing to 0.4- 2, and 10 mg if not responding (Goldfrank Method). The 50 patients in the control group receive naloxone with dose 0.1 mg repeated every 3 minutes until reversal of the signs and symptoms of toxicity (Tintinalli Method). The patients will then be compared regarding the reversal of the overdose signs and symptoms and the time needed for that and occurrence of withdrawal signs and symptoms to determine the preferred method. Only the patients are blind to the dose of naloxone administered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041710133N2
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Hossein Hassanian-Moghaddam
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
hassanian@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
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two different regimens of naloxone in treatment of methadone-overdosed addicted patients
Public title
Comparison of two different regimens of naloxone in treatment of methadone-overdosed addicted patients
Purpose
Treatment
Inclusion/Exclusion 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
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Behesti University of Medical Sciences
Street address
Yaman St, Velenjak
City
Tehran
Postal code
198396-3113
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
IR.SBMU.RAM.REC.1394.530
Health conditions studied
1
Description of health condition studied
Opioid Poisoning
ICD-10 code
T40
ICD-10 code description
T40
Primary outcomes
1
Description
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 outcomes
1
Description
occurence of withdrawal syndrome
Timepoint
every 5 to 10 minutes
Method of measurement
check of withdrawal signs and symptoms
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Hossein Hassanian-Moghaddam
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Toxicological Research Center-ُShahid Beheshti University of Medical Sciences-Vice Chancellor for Re
Full name of responsible person
Dr Arezou Mahdavinejad
Street address
Toxicological Research Center- 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-ُShahid Beheshti University of Medical Sciences-Vice Chancellor for Re
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
Poisoning Ward-Loghman Hakim Hospital
Full name of responsible person
Dr Navid Khosravi
Position
Fellowship of clinical toxicology
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
khosravi.navid@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Clinical Toxicology
Full name of responsible person
Dr Hossein Hassanian-Moghaddam
Position
Assistant Professor
Other areas of specialty/work
Street address
Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5541 9005
Fax
Email
hasanian2000@yahoo.com, hassanian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Loghman Hakim Poisoning Ward
Full name of responsible person
Dr Navid Khosravi
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
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)