Comparison between clonidine and tizanidine as adjuvant therapy in managing opioid withdrawal syndrome in toxicology icu in Kosar hospital of Karaj and Loghman Hakim hostpital of Tehran
Evaluating the effects of tizanidine and clonidine in adjuvant therapy in withdrawal syndrome management
Design
Two arm parallel group randomized clinical trial with blinded cases.
For randomization, the Random allocation software will be used.
Settings and conduct
The place for conducting the research is the toxicology ICUs of Kosar hospital of Karaj and Loghman Hakim hospital of Tehran.
Withdrawal syndrome signs will be evaluated using Objective Opioid Withdrawal Scale questionnaire.
The patients won't be aware of their group placement.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with history of opioid drug abuse whom urine test verifies that.
Exclusion criteria: Acute cardiac disease, other underlying disease, permanent brain damage like encephalopathy
Intervention groups
2 groups:
*Methadone and clonidine
*Methadone and tizanidine
Comparison between clonidine and tizanidine as adjuvant therapy in managing opioid withdrawal syndrome in toxicology icu in Kosar hospital of Karaj and Loghman Hakim hostpital of Tehran
Public title
Clonidine vs tizanidine for withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the hospitalized patients in toxicology ICU in hospitals Kosar of Karaj and Loghman Hakim of Tehran who are addicted to opioids
Exclusion criteria:
No consent from patient's family
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
First, a number is assigned to each participant and then the numbers are evenly divided into two blocks of clonidine or tizanidine by Random allocation software using simple block randomization method. For this purpose, after installing the program, we determine the number of groups, the sample size and the name of each group. Then, the software places patients with different codes in different groups according to the size of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients who are hospitalized in these wards don't have a high level of consciousness and if the family gives consent, they will enter into the project. In this case the patients and their families won't be aware of the group of the patient. The medicine will be administered without label and with exact similar appearance therefore the patients cannot guess their medicine.
The data will be encrypted and the person who analyzes the data won't be aware of the groups of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, North Taleghani Blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.ABZUMS.REC.1399.274
Health conditions studied
1
Description of health condition studied
Opioid withdrawal syndrome
ICD-10 code
F11.23
ICD-10 code description
Opioid dependence with withdrawal
Primary outcomes
1
Description
The Objective Opiate Withdrawal Scale (OOWS)
Timepoint
Evaluating OOWS score in 6, 12, 24, 72 and 120 hours after hospitalization.
Method of measurement
By using OOWS questionnaire
Secondary outcomes
1
Description
Sedation level
Timepoint
6, 12, 24, 72 and 120 hours after hospitalization.
Method of measurement
Recording level and content of consciousness.
2
Description
Length of hospitalization
Timepoint
At the time of discharge
Method of measurement
Patient's charts
Intervention groups
1
Description
Intervention group: Methadone and Tizanidine. Methadone from pharmaceutical company, 5mg q12h. Tizanidine from Aboureyhan pharmaceutical company, 4mg q12h , will be increased upto twice if signs are not relieved. Both will be administered intravenously until the patient is discharged.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Hoorvash Faraji Dana
Street address
Kharazmi blvd., Hesarak, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3197914795
Phone
+98 26 3428 4761
Email
kosarhp@abzums.ac.ir
2
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Hoorvash Faraji Dana
Street address
Makhsous St., Lashgar intersection, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
Web page address
http://lhmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Alborz University of Medical Sciences
Full name of responsible person
Hoorvash Faraji Dana
Street address
Alborz University of Medical Sciences, North Taleghani blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
f.drhoorvash@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Alborz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hoorvash Faraji Dana
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Forensic Medicine
Street address
Alborz University of Medical Sciences, North Taleghani blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
f.drhoorvash@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hoorvash Faraji Dana
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Forensic Medicine
Street address
Alborz University of Medical Sciences, North Taleghani blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
f.drhoorvash@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Hoorvash Faraji Dana
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Forensic Medicine
Street address
Alborz University of Medical Sciences, North Taleghani blvd., Taleghani Sq., Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3255 5000
Email
f.drhoorvash@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available