Comparison of the efficacy of varenicline and transcranial direct current stimulation (tDCS) in smoking cessation
Design
In this study, 106 smokers living in Arak will be divided into two equal groups of varenicline and TDCS using permuted block randomization method, considering inclusion and exclusion criteria.
Settings and conduct
The study is a randomized clinical trial. In this study, 106 patients will be divided into two completely equal groups of intervention and control. In the intervention group, 10 sessions of tDCS will be done with 2 milliampere stimulation for 20 minutes every day. In the control group, the varenicline tablets will be prescribed for 6 weeks, starting from half of milligram daily from the first day to 3rd and will be continued on the day 4th to 7th for half milligram every 12 hours, and 1 milligram every 12 hours from the 8th day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Smokers at the age of 18-65
Having a minimum literacy
Informed consent
Exclusion criteria:
Request from the patient or the patient's legal guardian to leave the study
Occurrence of harmful or intrusive side effects due to Varenicline or tDCS
Contraindication of tDCS
Epilepsy
Dementia, delirium or other cognitive disorders
Any history of psychiatric disorders
Any history of attempting to smoke cessation including, Varenicline or Bupropion tablets, nicotine gum and nicotine patch
Intervention groups
The intervention group:
In the intervention group, 10 sessions of 2 milliampere stimulation of tDCS will be done for 20 minutes every day.
The control group:
In the control group, the varenicline tablets will be prescribed for 6 weeks, starting from half of milligram daily from the first day to 3rd and will be continued on the day 4th to 7th for half milligram every 12 hours, and 1 milligram every 12 hours from the 8th day.
Main outcome variables
Severity of nicotine dependence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181026041468N4
Registration date:2021-08-11, 1400/05/20
Registration timing:registered_while_recruiting
Last update:2021-08-11, 1400/05/20
Update count:0
Registration date
2021-08-11, 1400/05/20
Registrant information
Name
Mehran Shayganfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 5075
Email address
mshayganfard@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-21, 1400/04/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of Varenicline and transcranial direct current stimulation (tDCS) in smoke cessation
Public title
Comparison of efficacy of Varenicline and transcranial direct current stimulation (tDCS) in smoke cessation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Smokers at the age of 18-65
Having a minimum literacy
Informed consent
Exclusion criteria:
Request from the patient or the patient's legal guardian to leave the study at any time of the study
Occurrence of harmful or intrusive side effects due to Varenicline or tDCS
Any contraindications of tDCS
Epilepsy
Dementia, delirium or other cognitive disorders
Any history of psychiatric disorders
Severe smoking
Any history of attempting to smoke cessation including, Varenicline or Bupropion tablets, Nicotine gum and nicotine patch
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
In this study restricted randomization method is used, which in order to create a balance in the samples assigned to each of the study groups, we will use the block randomization method with quadruple blocks. First the required blocks are numbered using a table of random numbers. Each block is assigned 2 samples for intervention and 2 samples for control. The samples for the intervention group (tDCS) are called A and the samples for the control group (receiving varenicline tablets) are called B. Then the sequence of these samples (A and B) for each block is determined using sequence generation software called (Random Allocation Software) RAS and finally based on the number of blocks and sequences assigned to each block is determined that Samples belong to intervention group A (tDCS) or control group B (receiving varenicline tablets). For concealment, blocking and allocation sequence is done by a person not involved in the research.
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
کمیته اخلاق دانشگاه علوم پزشکی اراک
Street address
Deputy of research and technology, Arak university of medical sciences, Payambar Azam university complex.
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.ARAKMU.REC.1400.005
Health conditions studied
1
Description of health condition studied
Nicotine dependence
ICD-10 code
F17.21
ICD-10 code description
Nicotine dependence, cigarettes
Primary outcomes
1
Description
Smoke cessation
Timepoint
Beginning and the end of the intervention
Method of measurement
Nicotine dependence scale (NDSS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, 10 sessions of 2 milliampere stimulation of tDCS will be done for 20 minutes every day.
Category
Treatment - Devices
2
Description
In the control group, the varenicline tablets will be prescribed for 6 weeks, starting from half of milligram daily from the first day to 3rd and will be continued on the day 4th to 7th for half milligram every 12 hours, and 1 milligram every 12 hours from the 8th day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital, Arak
Full name of responsible person
Seyed Vahid Mousavi
Street address
Amir Kabir hospital, Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
381961187
Phone
+98 86 3313 4715
Email
mshayganfard@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak university of medical sciences, Sardasht
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3312 4955
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehran Shayganfard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Alamolhoda St.
City
Arak
Province
Markazi
Postal code
381961187
Phone
+98 86 3313 4715
Email
mshayganfard@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Shayganfard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Alamolhoda St.
City
Arak
Province
Markazi
Postal code
381961187
Phone
+98 86 3313 4715
Email
mshayganfard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Shayganfard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Amirkabir hospital, Alamolhoda St.
City
Arak
Province
Markazi
Postal code
381961187
Phone
+98 86 3313 4715
Email
mshayganfard@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
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
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