Comparison of the effect of gabapentin with topiramate on the effects of opioid withdrawal syndrome with the aim of finding a more effective drug in this field to prevent relapse
Design
A randomized, non blinded, Controlled clinical trial with parallel groups
Settings and conduct
This study is a controlled clinical trial performed on 60 patients admitted to the psychiatric ward of Shariati Hospital of Fasa who are opioid dependent according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders and are admitted to this hospital for detoxification. The instrument for measuring the severity of withdrawal symptoms is the questionnaire of Subjective opiate withdrawal scale, which includes 16 opioid withdrawal symptoms and each symptom is scored from zero to 4 based on severity. In each patient, this questionnaire is completed every two days. .
Participants/Inclusion and exclusion criteria
Conditions for entering the study: Detection of opioid dependence according to DSM-V criteria
Conditions for not entering the study: Major medical diseases, Pregnancy and lactation period
Intervention groups
Patients in the first group receive 300-1200 mg of gabapentin daily and patients in the second group receive 100-300 mg of topiramate daily for one to a maximum of three weeks.
Main outcome variables
The main outcome variable includes the score of opioid withdrawal syndrome, which is measured in 6 stages including the first day before the intervention and the 3rd, 5th, 7th, 9th and 11th days after starting gabapentin or topiramate through a questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210427051102N1
Registration date:2021-05-16, 1400/02/26
Registration timing:prospective
Last update:2021-05-16, 1400/02/26
Update count:0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Bahare Fakhraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5331 5749
Email address
b.fakhraee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Topiramate and Gabapentin in Opioid withdrawal syndrome
Public title
Comparison of the effects of Topiramate and Gabapentin in Opioid withdrawal syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of opioid dependence according to DSM-V criteria
Exclusion criteria:
Major medical diseases including cardiovascular, pulmonary, renal and gastrointestinal disorders
Pregnancy and Lactation period
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We put 60 cards in the envelope, 30 of which are written with gabapentin and the other 30 with topiramate and we ask the patient to choose one of the cards, and the selected card shows which group the patient belongs to. .
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 Fasa University of Medical Sciences
Street address
Ibn Sina Square, Fasa university of medical science
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2021-03-06, 1399/12/16
Ethics committee reference number
IR.FUMS.REC.1399.175
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 score of Opioid Withdrawal Syndrome in the Questionnaire
Timepoint
Before intervention and 3, 5, 7, 9 and 11 days after starting gabapentin or topiramate
Method of measurement
Subjective Opiate Withdrawal Scale
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the first group take 300-1200mg of oral Gabapentin daily from Poursina company for one to a maximum of three weeks.
Category
Treatment - Drugs
2
Description
Patients in the second group take 100-300 mg of topiramate daily from Sobhan Daru Company for one to a maximum of three weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr.Bahare Fakhraei
Street address
Shahid Dr. Fayyaz Bakhsh St.
City
Fasa
Province
Fars
Postal code
7461985979
Phone
+98 71 5331 4234
Email
b.fakhraee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Farjam
Street address
Ibn Sina Square, Fasa University of Medical Sciences and Health Services, Additional Building, Ground Floor, Office of the Vice Chancellor for Research and Technology
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 6300
Email
p.rajabi75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Parmida Rajabi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ibn Sina Square, Fasa univercity of medical sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5333 2326
Email
p.rajabi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Bahare Fakhraei
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn Sina Square, Vali Asr Hospital, Medical doctor building, block 3
City
Fasa
Province
Fars
Postal code
7461747377
Phone
+98 71 5331 5749
Fax
Email
b.fakhraee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Parmida Rajabi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ibn Sina Square, Fasa univercity of medical sciences
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5333 2326
Email
p.rajabi75@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after identifying individuals.
When the data will become available and for how long
The beginning of the access period from 1401
To whom data/document is available
researchers and people working in medical universities of the country
Under which criteria data/document could be used
For research purposes and in collaboration with Fasa University of Medical Sciences
From where data/document is obtainable
Dr. Mojtaba Farjam Faculty Member of Fasa University of Medical Sciences
What processes are involved for a request to access data/document
Contact with Dr. Mojtaba Farjam, the project manager via email : farjam.md@gmail.com