|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT2015011020624N1 |
|
Date of registration:
|
2015-11-27 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study
|
|
Scientific title:
|
Comparison of naloxone & buprenorphine on reversal of Opioid Overdose Syndrome and withdrawal in Methadone – Dependant Patients; An experimental Study |
|
Date of first enrolment:
|
2016-03-21 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/18265 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
|
|
Phase:
|
0 (exploratory trials)
|
|
|
Countries of recruitment
|
|
Iran (Islamic Republic of)
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr. Nasim Zamani
|
|
Address:
|
Department of Clinical Toxicology-Loghman Hakim Hospital
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5542 4041 |
|
Email:
|
nasim.zamani@gmail.com |
|
Affiliation:
|
Shahid Beheshti University of Medical Sciences |
|
|
Name:
|
Dr Nasim Zamani
|
|
Address:
|
Department of Clinical Toxicology-Loghman Hakim Hospital
Tehran
Iran (Islamic Republic of) |
|
Telephone:
|
+98 21 5542 4041 |
|
Email:
|
nasim.zamani@gmail.com |
|
Affiliation:
|
Shahid Beheshti University of Medical Sciences |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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.
Exclusion criteria:
Age minimum:
12 years
Age maximum:
100 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Poisoning by Methadone
|
Methadone Overdose.
Poisoning by Methadone
|
|
Intervention(s)
|
|
Buprenorphine (5micro/kg; 1st Control Group)
|
|
Buprenorphine (10micro/kg; 2nd Control group)
|
|
Narcan Injection (case group)
|
|
Intervention 1: Narcan Injection (case group). Intervention 2: Buprenorphine (5micro/kg; 1st Control Group). Intervention 3: Buprenorphine (10micro/kg; 2nd Control group).
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
Reversal of Respiratory Depression. Timepoint: 1 min. Method of measurement: reversal of respiratory rate.
|
|
Secondary Outcome(s)
|
|
Reversal of cyanosis and increased O2 Saturation. Timepoint: 2 minutes. Method of measurement: Pulse Oximetry.
|
|
Source(s) of Monetary Support
|
|
Shahid Beheshti University of Medical Sciences
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Shahid Beheshti University Medical Sciences Ethics Commitee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|