A total of 90 opioid-dependant patients who have referred after methadone overdose will randomly been assigned into either buprenorphine or naloxone group. the patients in buprenorphine group will themselves been assined into two groups of 5 microgram/kg and 10 microgram/kg. The patients in the naloxone group will receive naloxone with 0.05 mg initial dose and the doubling incremental dosing every 3-5 minutes. The patients will then be watched for signs and symptoms of withdrawal or response to the treatment (reversal of apnea, cyanosis, loss of consiousness, etc). The three groups will finally be compared regarding these variables and outcome. If they are not responding to the treatments given, they will be intubated and excluded from the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011020624N1
Registration date:2015-11-27, 1394/09/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-11-27, 1394/09/06
Registrant information
Name
Nasim Zamani
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
nasim.zamani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-03-21, 1395/01/02
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study
Public title
Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all opioid-dependant patients who refer after methadone overdose will be included and randomly assigned into either case (buprenorphine with two different doses) or control (naloxone) group.
Exclusion criteria:
1-Those younger than 12 years of age and older than 100 years will be excluded.
2- Patients with multiple drug overdoses will be excluded.
3-Patients who do not respond to the buprenorphien and naloxone doses and are in life-treathening situation will be intubated and excluded from the study.
Age
From 12 years old to 100 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University Medical Sciences Ethics Commitee
Street address
Shahid Beheshti University of Medical Sciences, Yaman St, Velenjak
City
Tehran
Postal code
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
IR.SBMU.RAM.REC.1394.62
Health conditions studied
1
Description of health condition studied
Methadone Overdose
ICD-10 code
T40.3
ICD-10 code description
Poisoning by Methadone
Primary outcomes
1
Description
Reversal of Respiratory Depression
Timepoint
1 min
Method of measurement
reversal of respiratory rate
Secondary outcomes
1
Description
Reversal of cyanosis and increased O2 Saturation
Timepoint
2 minutes
Method of measurement
Pulse Oximetry
Intervention groups
1
Description
Narcan Injection (case group)
Category
Treatment - Drugs
2
Description
Buprenorphine (5micro/kg; 1st Control Group)
Category
Treatment - Drugs
3
Description
Buprenorphine (10micro/kg; 2nd Control group)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Clinical Toxicology-Loghman Hakim Hospital
Full name of responsible person
Dr Nasim Zamani
Street address
South Karegar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mopstafa Rezaei Tavirani
Street address
Shahid Beheshti University of Medical Sciences, Yaman Street, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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. Nasim Zamani
Position
Assistant Professor-
Other areas of specialty/work
Street address
Department of Clinical Toxicology-Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4041
Fax
Email
nasim.zamani@gmail.com
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 Nasim Zamani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Clinical Toxicology-Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4041
Fax
Email
nasim.zamani@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. Nasim Zamani
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Clinical Toxicology-Loghman Hakim Hospital
City
Tehran
Postal code
Phone
+98 21 5542 4041
Fax
Email
nasim.zamani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)