Comparison the effect of Cytisine versus nicotine for smoking cessation in psychiatric patients
Design
Parallel Clinical trial with control group
Settings and conduct
Intervention groups include patients over the age of 18 in the psychiatric ward of the Taleghani Hospital who tend to quit cigarette. To one group chewing gum or nicotine patch is given for a 2-week treatment period and the other group receive the Tabax tablet for 25 days according to the approved protocol of the manufacturer. Patients are then evaluated for signs and responses in the first week and months 1, 2 and 6 respectively
Participants/Inclusion and exclusion criteria
Aged over 18;
Daily cigarette smoking;
The desire to quit smoking
Do not be pregnant;
No recent (past 2 weeks) cardiovascular events.
Intervention groups
Intervention is done in two groups:The first intervention group receive chewing gum or nicotine patch for a 2-week treatment period. The second intervention group is given Tabex tablet according to the protocol approved by the company.
Main outcome variables
Smoking cessation; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003210N16
Registration date:2019-01-14, 1397/10/24
Registration timing:prospective
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Maria Tavakoli Ardakani
Name of organization / entity
Faculty of pharmacy, Shaid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
mariatavakoli@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cytisine versus nicotine for smoking cessation in hospitalized psychiatric patients.
Public title
Cytisine versus nicotine for smoking cessation in hospitalized psychiatric patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years of age
Daily smokers
Motivated to quit
Exclusion criteria:
Pregnant or breast-feeding women
Enrolled in another cessation program or study
Systolic blood pressure above 150 mm Hg
Diastolic blood pressure above 100 mm Hg
Cardiovascular event in the 2 weeks before study enrollment
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Vali-e-asr ave., Niyayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
ir.sbmu.phnm.1396.872
Health conditions studied
1
Description of health condition studied
Smoking cessation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Smoking cessation
Timepoint
1 week and at1, 2 and 6 months after quit day
Method of measurement
1)mood and physical symptoms scale (MPSS)The AUDIT alcohol 2)consumption questions (AUDIT-C)Confirmatory factor analyses and 3)reliability of the modified cigarette evaluation questionnaire
Intervention group: Patients taking tabex tablets of Sopharma Bulgaria in the form of protocol approved by the company.The Cytisine protocol is as follows:Days 1 to 3: 6 tablets a day, 4 to 12 days daily 5 tablets, 13 to 16 days daily 4 tablets, days 17 to 20 daily 3 tablets and days 21 to 25 daily 2 tablets.Then the patients are evaluated in the first week and in the 1st, 2nd and 4th months after the start of the pill.
Category
Other
2
Description
Intervention group: Patients using nicotine gum or patch. Patients use nicotine gum or nicotine patches for 8 weeks. Then, the patients are examined at the first week and 1, 2, and 4 months after starting the use.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Zeynab Gholamzadeh Sani
Street address
Arabi St., Yaman St., Chamran highway.,Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 8887 3704
Email
zeynab.gholamzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli-Ardakani
Street address
Vali-e-asr Ave., Niyayesh junction., Shahid Beheshti pharmacy school
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0085
Email
Mariatavakoli@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeynab Gholamzadeh Sani
Position
Pharma student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-Asr Ave., Niayesh junction, School of Pharmacy, Shahid Beheshti university of medical sciences
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
zeynab.gholamzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maria Tavakoli ardakani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr Ave., Niayesh junction
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
Mariatavakoli@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeynab Gholamzadeh Sani
Position
PharmD student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Vali-e-asr Ave., Niyayesh junction., Shahid Beheshti pharmacy school
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8887 3704
Email
zeynab.gholamzadeh@yahoo.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
Information are confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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