(1) Objectives: This study aims at investigating the effectiveness Gemfibrozil on
treatment of smoker's nicotine dependence in Kashan. (2) Design: This is a pretest-posttest experimental study. The intervention also includes a twelves-weeks follow-up course. (3) Methods: A sample of 76 eligible smokers will be recruited. That will be randomly allocated to either the experimental or the control groups. Smokers in the experimental group will receive Gemfibrozil while the smokers in the control group will receive placebo. Study instruments include fagestrom dependence scale, Minnesota Nicotine Withdrawal Scale and the exhaled CO2 detector. These instruments will be completed before intervention,weekly measure during 7 weeks of intervention and 8,11,14,19 weeks after beginning of intervention.(4) Inclusion Criteria: Having an age of 19–65 years; nicotine dependence based on DSM 5; lack of history of psychotic disorders; having negative results in opioid and amphetamines test; lacking diagnosis of chronic disease such as debate, blood pressure , cancer and etc; Not be pregnant. Exclusion criteria: Unwillingness to continue participating in the study; being pregnancy during study; uses drugs with contraindication or Interference with Gemfibrozil such as Anticoagulants, statins, other fibrates and niacin. (6) Intervention: The intervention of this study is 300 mg twice on day of Gemfibrozil. (7) Primary outcomes: The primary outcomes are Nicotine Withdrawal, nicotine dependence and smoking cessation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101732057N3
Registration date:2017-11-01, 1396/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Mohamad Reza Davoudi
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2999
Email address
davoudi-mr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-12-15, 1394/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Gemfibrozil for treatment of cigarette dependence
Public title
effect of Gemfibrozil for treatment of cigarette
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having an age of 19–65 years; nicotine dependence based on DSM 5; lack of history of psychotic disorders; having negative results in opioid and amphetamines test; lacking diagnosis of chronic disease such as debate, blood pressure , cancer and etc; Not be pregnant. Exclusion criteria: Unwillingness to continue participating in the study; being pregnancy during study; uses drugs with contraindication or Interference with Gemfibrozil such as Anticoagulants, statins, other fibrates and niacin.
Age
From 19 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The population consisted of all smokers admitted to center treatment of drug abuse and smoking in Kargrnzhad psychiatric hospital. from all participation's that meets inclusion criteria, 38 participants for each group selected by Random assignment will be done,that by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kashan University of Medical Sciences and Health Services
Street address
Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
IR.KAUMS.REC.1394.29
Health conditions studied
1
Description of health condition studied
nicotine dependence
ICD-10 code
F17
ICD-10 code description
Mental and behavioural disorders due to use of tobacco
Primary outcomes
1
Description
smoking cessation
Timepoint
Before intervention; 1,2,3,4,5,6,7,8,11,14,19 after beginning of intervention.
Method of measurement
Expiratory CO2 concentration
2
Description
nicotine dependence
Timepoint
Before intervention; 1,2,3,4,5,6,7,8,11,14,19 after beginning of intervention.
Method of measurement
fagestrom nicotine dependence scale
3
Description
Nicotine Withdrawal
Timepoint
Before intervention; 1,2,3,4,5,6,7,8,11,14,19 after beginning of intervention.
Method of measurement
Minnesota Nicotine Withdrawal Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: This group receives placebo for seven weeks
Category
Treatment - Drugs
2
Description
Intervention group: Gemfibrozil 300 mg for twice daily mg for seven weeks
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maohamadreza Davoudi
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
msc.davoudi.psy@gmail.comdavoudi-mr@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maryam Shahriyari
Position
Psychiatrist
Other areas of specialty/work
Street address
Kargarnejad psychiatric Hospital, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
mshahriari80@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maohamadreza Davoudi
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 9111
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)