Comparison and Combination the effectiveness of transcranial direct current stimulation and varenicline on excutive function, cravings, depression, anxiety and stress in smokers with major depressive disorder
Determining the amount of reduction of craving, depression, anxiety, executive function and improvement of negative affect through transcranial direct current stimulation and its synergistic effects with varenicline drug in depressed people dependent on nicotine smoking.
Design
Clinical trial with two intervention groups, one-blind, randomized, phase 2 on 100 patients who will be randomly assigned to two intervention groups.
Settings and conduct
Zanjan University of Medical Sciences, Shahid Beheshti Hospital, Varoniclin drug prescription, brain stimulation device, clients who smoke are assigned to two groups without knowing their placement.
Participants/Inclusion and exclusion criteria
1- Having the ability to give informed consent to participate in the research 2- Being at least 18 and at most 65 years old 3- Daily consumption of more than ten cigarettes for at least two years (14). 4- Non-use of other substances such as: methamphetamine, opioid and benzodiazepine (specified through clinical interview by Ballinger). 5- Having a diagnosis of major depression. 6- Failure to consider other severe psychiatric disorders
Intervention groups
smokers
Main outcome variables
Craving, negative emotion, anxiety, depression, improvement of executive functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221214056816N1
Registration date:2023-02-12, 1401/11/23
Registration timing:registered_while_recruiting
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
zakaria eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6444
Email address
dreskandari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-05, 1401/11/16
Expected recruitment end date
2023-05-04, 1402/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and Combination the effectiveness of transcranial direct current stimulation and varenicline on excutive function, cravings, depression, anxiety and stress in smokers with major depressive disorder
Public title
effectiveness of transcranial direct current stimulation and varenicline on, excutive function, cravings and,depression, anxiety and stress in smokers with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the ability to give informed consent to participate in research
Being at least 18 and at most 65 years old
Daily consumption of more than ten cigarettes for at least two years(14)
Non-use of other substances such as: methamphetamine, opioid and benzodiazepine (specified through clinical interview by Ballinger)
Having a diagnosis of major depression
Failure to consider other severe psychiatric disorders that will be screened through the structured interview of SKID
Exclusion criteria:
Consuming more than one marijuana cigarette per week
Having a history of neurological diseases such as Parkinson's, epilepsy, convulsions, strokes and cardiovascular problems
Having diseases related to the scalp
Having a history of head trauma
Presence of a device or tool in the head
Exiting from the research after absence In two continuous sessions of treatment
Pregnancy or breastfeeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done through simple random method using coin toss. In this way, subjects are randomly assigned to treatment and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be done in such a way that the subjects and the therapist are not aware of the assignment to the groups and the statistical analyst will also be blind to the therapist and the subjects.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Research Ethics Committee
Street address
Zanjan University of Medical Sciences-Shahid Beheshti Hospital, Department of Addiction Studies
City
Zanjan
Province
Zanjan
Postal code
4513615788
Approval date
2022-12-13, 1401/09/22
Ethics committee reference number
IR.ZUMS.REC.1401.265
Health conditions studied
1
Description of health condition studied
People with smoking
ICD-10 code
Z72.0
ICD-10 code description
Tobacco use
Primary outcomes
1
Description
Decreasing score in depression, anxiety, stress Scale(DASS)
Timepoint
3 Month
Method of measurement
Dass questionnaire
2
Description
Decreasing score in mood profile
Timepoint
3 Month
Method of measurement
mood profile questionnaire
3
Description
Decreasing score in craving questionnaire
Timepoint
3 Month
Method of measurement
craving questionnaire
4
Description
Improving inhibition in Stroop test
Timepoint
3 Month
Method of measurement
Stroop software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: common protocol to reduce cravings in smokers through extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode), prefrontal cortex The dorsal side is left.
Category
Treatment - Other
2
Description
Intervention group: The use of varenicline is usually started as follows: the first three days, one tablet of 500 micrograms daily, days 4 to 7 one tablet (500 micrograms), from the 8th day onwards, one tablet of 1 mg twice a day. The complete period of taking varenicline is 12 weeks. It is possible that according to the doctor's opinion, in case of success in quitting smoking, it may continue for more than 12 weeks.
Category
Treatment - Drugs
3
Description
Intervention group: The protocol for the sham group is through the extracranial stimulation device (tDCS), placing the stimulating electrode (anode) on the right dorsolateral prefrontal cortex (DLPFC) and the inhibitory electrode (cathode) on the left dorsolateral prefrontal cortex. It runs for 40 seconds.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Davood Ahmadi
Street address
Shahid Beheshti Hospitalَ Arg Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 5224 4001
Fax
Email
Eskandari.Psychology@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Research and Technology Unit Zanjan University of Medical Sciences -
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3354 4001
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Eskandari Zakaria
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital Zanjan University of Medical Sciences,
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
eskandari.psychology@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zakaria Eskandari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital Zanjan University of Medical Sciences,
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
0098 33544001
Email
Eskandari.Psychology@Gmail.Com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Eskandari Zakaria
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti Hospital, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
eskandari.psychology@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of each person's private data, the data is shared in the form of an article.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data and statistical analysis are shared through the article.
When the data will become available and for how long
2023
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
citing the source
From where data/document is obtainable
It is uploaded on scientific sites
What processes are involved for a request to access data/document
Through correspondence with the project manager's email
Comments
After the data is ready, the data will be shared with the article