The aim of this study was to determine the effectiveness of nicotine on
working memory and positive emotion in patients with MCI (Mild Cognitive Impairment).
Design
Clinical trial with control group, with parallel group, double-blind, randomized, phase 2 on 30 patients. For randomization, SNOSE method (sealed envelope) and computer software for generating random numbers were used.
Settings and conduct
This study was performed in neurology clinics in Tabriz. Patients were selected by convenience sampling method. Then they were randomly divided into control and intervention groups. The intervention group was given chewing gum contain of nicotine and the control group was given non-nicotine gum. Participants, researchers and analyzers of the results, were unaware of the study groups type (blinded).
Participants/Inclusion and exclusion criteria
Participants included 30 male patients referred to clinics and medical centers in Tabriz city who were selected by convenience sampling method and randomly assigned to the control and intervention groups. Inclusion criteria included male patients, age between 20 and 60 years, having a definitive diagnosis of mild cognitive impairment, no heart and brain disease, no use of psychiatric drugs, no hypertension and no smoking. Exclusion criteria also included unwillingness to participate in the study or withdrawal from the study and the occurrence of side effects after nicotine use.
Intervention groups
The intervention group consisted of 15 male patients with mild cognitive impairment who received chewing gum containing 2/mg of nicotine.The control group also included 15 male patients with mild cognitive impairment who received non-nicotine gum.
Main outcome variables
Enhancement of working memory, increase of positive affect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190418043313N1
Registration date:2022-01-13, 1400/10/23
Registration timing:retrospective
Last update:2022-01-13, 1400/10/23
Update count:0
Registration date
2022-01-13, 1400/10/23
Registrant information
Name
Esmail Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 2103
Email address
esmailkhodadadi11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-02, 1398/02/12
Expected recruitment end date
2019-06-02, 1398/03/12
Actual recruitment start date
2019-05-02, 1398/02/12
Actual recruitment end date
2019-05-31, 1398/03/10
Trial completion date
2019-06-05, 1398/03/15
Scientific title
The Effect of Nicotine on Cognitive functions and Positive Affection in individual with Mild Cognitive Impairment
Public title
The effect of nicotine on cognitive function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients
Age between 20 and 60 years
Have a definitive diagnosis of mild cognitive impairment
No risk of heart and brain disease
No use of psychiatric drugs
No risk of hypertension
Not being a smoker
Exclusion criteria:
Having severe cognitive impairment
Inability to communicate with researcher and answer the questionnaire
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were assigned to two groups of intervention and control, randomly and using random numbers by computer software to generate random numbers (Random sequence generation). Also, the SNOSE (Sequentially numbered, opaque, sealed envelope) method was used for concealment. The number of envelope numbers was prepared and a number was placed inside each of them. The sealed envelopes were then selected by an anonymous person, and after the envelopes were opened, the type of group of participants was determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is blinded for participants, principal investigator and co-researcher, data collectors, outcome assessor and data analyser. It should be noted that participants were explained about the purpose and intervention and informed consent was obtained from them, but to avoid bias, they were not informed about their group in study.
Placebo
Used
Assignment
Parallel
Other design features
The design of this study, is before and after intervention with the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University-Tabriz Branch
Street address
Islamic Azad University, Tabriz Branch, Basij Highway, Azad University Square.
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.IAU.TABRIZ.REC.1397.032
Health conditions studied
1
Description of health condition studied
Mild cognitive impairment
ICD-10 code
G31.84
ICD-10 code description
Mild cognitive impairment, so stated
Primary outcomes
1
Description
Working memory score in Wechsler Memory Scale
Timepoint
Before and after 2 hours of intervention
Method of measurement
Wechsler Memory Scale
2
Description
Positive affect score in PANAS questionnaire
Timepoint
Before and after 2 hours of intervention
Method of measurement
Positive and Negative Affect Schedule (PANAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Each member of the intervention group was given a chewing gum made by Nikolife Company containing 2 mg of nicotine at a time and the participants chewed it for 2 hours.
Category
Treatment - Other
2
Description
Control group: Receiving of chewing gum without nicotine for 2 hours.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Imam Reza Hospital, Tabriz
Full name of responsible person
Esmail Khodadadi
Street address
Golgasht Street, front of the central organization of the Tabriz university of medical sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7059
Fax
Email
esmailkhodadadi11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmail Khodadadi
Street address
Basij Highway, Azad University Square, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3331 8681
Email
esmailkhodadadi11@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Tabriz Branch
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
Islamic Azad University
Full name of responsible person
Esmail Khodadadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Basij Highway, Azad University Square, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3331 8681
Email
esmailkhodadadi11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmail Khodadadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Basij Highway, Azad University Square, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3331 8681
Email
esmailkhodadadi11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Esmail Khodadadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Basij Highway, Azad University Square, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3331 8681
Email
esmailkhodadadi11@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 potential data can be shared after identifying participants.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions