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Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome in patients admitted to the Toxicology ICU of Luqman Hakim Hospital from 2023 to 2025

Protocol summary

Study aim
The aim are Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome in patients admitted to the Toxicology ICU of Luqman Hakim Hospital from 2023 to 2025.
Design
This clinical trial study has two intervention and control groups, unblinded, randomized, with parallel groups, on 52 patients admitted to the intensive care unit with opium withdrawal syndrome. The block method will be used for randomization.
Settings and conduct
This clinical trial study has two intervention groups, unblinded, randomized, on 52 patients with opium withdrawal syndrome and admitted to the intensive care unit at Luqman Hakim Hospital. The patients will be cases referring to Luqman Hakim Hospital in the years 2023 to 2025, who are willing to participate and do not have any other diseases. Block method will be used for randomization, 26 cases will be treated with clonidine and 26 cases will be treated with dexmethodomidine.
Participants/Inclusion and exclusion criteria
Patients with drug addiction, hospitalized in poisoning ICU, with the age of 18 to 75 years, who suffered from withdrawal syndrome during hospitalization, will be included in the study as a study group. Also, if the patient's companion does not agree to participate in the evaluation and contraindications of clonidine or dexmethodomidine use, they will be excluded from the study.
Intervention groups
The first group will be treated with dexmethodomidine at a rate of 0.5 micrograms/kg and the second group will be treated with clonidine up to 1.2 mg per day manufactured by Elixir Pharmaceutical Company.
Main outcome variables
Symptoms of opium withdrawal syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220305054196N3
Registration date: 2023-05-18, 1402/02/28
Registration timing: prospective

Last update: 2023-05-18, 1402/02/28
Update count: 0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Mitra Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 4041
Email address
mrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-21, 1402/02/31
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome in patients admitted to the Toxicology ICU of Luqman Hakim Hospital from 2023 to 2025
Public title
Comparison of the effects of two drugs, clonidine and dexmethodomidine, in the treatment of opiate withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with opium addiction Hospitalization in the poisoning ICU With age minimum 18 and maximum 75 years who have suffered withdrawal syndrome during hospitalization
Exclusion criteria:
Lack of consent of the patient to participate in the evaluation Contraindications to clonidine or dexmethodomidine
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the restricted randomization method of the block randomization type. The size of all the blocks is equal and we will have 13 blocks in this two-group trial, and considering 4 blocks, a total of 52 patients will be evaluated. The randomization tool will be random allocation software.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Approval date
2023-04-15, 1402/01/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.072

Health conditions studied

1

Description of health condition studied
Opium withdrawal syndrome
ICD-10 code
F11.23
ICD-10 code description
Opioid dependence with withdrawal

Primary outcomes

1

Description
Symptoms of Opium withdrawal syndrome
Timepoint
Before drug administration and 12 and 24 hours later
Method of measurement
Based on COWS checklist criteria

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first group, dexmethodomidine drug at the rate of 0.5 micrograms/kg manufactured by Elixir Pharmaceutical Company will be used.
Category
Treatment - Drugs

2

Description
Intervention group: The second group will be treated with clonidine up to 1.2 mg per day manufactured by Elixir Pharmaceutical Company .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Mitra Rahimi
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hale Talaie
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Ave, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 8175
Email
trc.info@sbmu.ac.ir
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azade Memarian
Position
Resident in toxicology
Latest degree
Medical doctor
Other areas of specialty/work
Toxicology
Street address
Toxicological Research Center, Loghman Hakim Hospital, Kamali Ave, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 8175
Email
A.memarian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mrahimi744@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mitra Rahimi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Poisoned Complex, Loghman Hakim Hospital, South Kargar St, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
mrahimi744@gmail.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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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