Evaluation of the effectiveness of topiramate in treating dependence of amphetamine and methamphetamine patients
Design
Phase 2-3 clinical trial study with parallel, double-blind and randomized groups based on randomized block permutation method.
Settings and conduct
Phase 2-3 clinical trial study with parallel, double-blind and randomized groups based on randomized block permutation method.The patient and the evaluator in this study are not aware of the medication received. The study site is located in Ahvaz city, Khuzestan province.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 55 years, with amphetamine and methamphetamine use disorder
Exclusion criteria: History of major psychiatric disorder, existence of harmful thoughts to oneself and others, existence of underlying medical illness, history of receiving psychiatric medication during the last 3 months, BMI less than 18, pregnant woman or breast feeding.
Intervention groups
The intervention group includes patients with amphetamine and methamphetamine use disorders to treat dependence with topiramate tablets with a starting dose of 50 mg per day and the dose of the drug is increased weekly and continues until the target dose of 200 mg.
The control group includes patients with amphetamine and methamphetamine disorders receiving placebo intervention. The placebo is similar to topiramate in appearance, color, odor, and dosage.
Main outcome variables
Intensity of dependence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160417027437N2
Registration date:2021-07-19, 1400/04/28
Registration timing:prospective
Last update:2021-07-19, 1400/04/28
Update count:0
Registration date
2021-07-19, 1400/04/28
Registrant information
Name
Amirali Moghaddam Sadegh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3038
Email address
moghaddam.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
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
Evaluation of the effectiveness of topiramate in treating dependence of amphetamine and methamphetamine patients
Public title
Evaluation of the effectiveness of topiramate in treating dependence of amphetamine and methamphetamine patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18-55 years
With amphetamine and methamphetamine use disorders
Exclusion criteria:
History of major psychiatric disorder
existence of harmful thoughts to oneself and others
history of receiving psychiatric medication during the last 3 months
pregnant woman or breast feeding
BMI less than 18
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. According to that, there are 2 treatments, for every block a different random order will be prepared. Random table was used as the randomization tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher and the patients are unaware of which drug or placebo they receive in either group. Medications and placebos will be similar in shape, color, and taste
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Junishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.015
Health conditions studied
1
Description of health condition studied
drug abuse
ICD-10 code
Other psyc
ICD-10 code description
F19
Primary outcomes
1
Description
Intensity of dependence
Timepoint
Weeks 2, 4, 6, 8, 10 and 12 after the intervention
Method of measurement
McLellan Dependency Index Questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
Weeks 2, 4, 6, 8, 10 and 12 after the intervention
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Intervention group: To treat amphetamine and methamphetamine dependence, topiramate tablets are started at a dose of 50 mg per day, the dose is increased weekly until the 12th week to reach a dose of 200. This pill will be provided by Aria Pharmacy.
Category
Treatment - Drugs
2
Description
Control group: For the treatment of amphetamine and methamphetamine dependence, placebo is started at a dose of 50 mg per day, the dose is increased weekly until the 12th week to reach a dose of 200. This pill is supervised and will be provided by by the Faculty of Pharmacy, Ahvaz University of Medical Sciences.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Amir Ali Moghadam Sadegh
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
moghaddam.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
m.ahmadimoghadam@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Ali Moghadam Sadegh
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
moghaddam.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Ali Moghadam Sadegh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
moghaddam.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Ali Moghadam Sadegh
Position
Ahvaz
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
moghaddam.a@ajums.ac.ir
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