- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04032236
Effect of Oral pH Changes on Smoking Desire
Nicotine is a psychoactive substance and its effect is demonstrated by neuronal nicotinic-acetylcholine receptors excreted in the brain and periphery. Psychoactive substances such as nicotine and caffeine play a role in rewarding through the mesolimbic dopaminergic system. The released dopamine produces pharmacological effects that can cause pleasurable emotions. These effects are an important factor in maintaining smoking motivation.
The rate of absorption of nicotine from the buccal mucosa, the rate and amount of dependence, significantly affects the risk. In addition to PH, other factors such as local blood flow, product nematode, size and surface area of the tobacco mixture, constant pH holding capacity, and nicotine content of the tobacco can affect nicotine absorption. To facilitate the absorption of nicotine from the buccal mucosa, various substances that increase absorption have been investigated. Increased alkalinity has been shown to increase nicotine absorption and physiological effects by buffering alkaline pH values with moist snuff products and nicotine gums. Although other factors may affect the nicotine absorption rate in oral tobacco, it is stated that the main factor that determines the rate of nicotine absorption is pH.
Factors that trigger nicotine use include stress in daily life, daily routines, eating and drinking habits, and especially the use of caffeine. The chronic use of caffeine causes tolerance in many of its effects, and the use of nicotine reduces tolerance effects and also potentiates the effects stimulated through the dopaminergic pathway. It has been reported that smokers consume more caffeine than non-smokers.
In the present study, the relationship between oral pH and cigarette demand after caffeine consumption will be investigated. Until now, the relation between cigarette pre- and post-caffeine saliva pH and cigarette smoking has not been investigated. In addition, the effects of drinking behavior and changes in salivary pH on cigarette desire will be investigated and evidence of behavioral methods applied in cigarette smoking cessation treatment will be provided.
Study Overview
Detailed Description
Nicotine dependence is accepted as the most common disease and can be treated with medical methods like other diseases. Scientifically proven pharmacotherapy as well as cognitive and behavioral therapy play an important role in reducing cigarette smoking. In this context, it is suggested that the motivation of the person should be questioned, the daily behavioral models should be questioned, the elements triggering the desire for smoking should be identified and the methods of combating them should be developed and the usual vital actions including eating and drinking should be organized. Consumption of acidic foods causes acidic pH in the mouth and salivation increases in order to neutralize it. After meals; tea or coffee, it was reported that smoking desire increases.
Caffeine is another psychostimulant substance found in varying proportions in coffee and tea, and its antagonistic effects on the locomotor system are at adenosine receptors level. Stimulated at low doses and depressed at high doses. Nicotine has a stimulating effect on locomotor activity in chronic use. The chronic use of caffeine causes tolerance in many effects, and nicotine use decreases tolerance effects and also potentiates the effects stimulated through the dopaminergic pathway. It has been reported that smokers consume more caffeine than non-smokers. There are also studies reporting that there is no interaction between caffeine and nicotine and that cocaine consumption increases cigarette smoking as well as epidemiological studies that relate caffeine and nicotine concurrent consumption to pharmacological effects rather than pharmacological effects after food and between studies that are the two most common actions due to stress. However, this effect is not entirely due to the pharmacological effects of caffeine, but influences the intraoral pH and affects the cigarette smoking desire. In this study, the main aim is to investigate the effect of changes in salivary pH on the desire to smoke and how the drinking behavior of water affected this desire.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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İzmir, Turkey, 35340
- Dokuz Eylül University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Not having an active disease
- Be between the ages of 18 and 45
- Not using antibiotics in the last two weeks
- Do not use inhaler treatments
- Not to have an oral or salivary gland disease
- One week after menstrual bleeding in female cases
- At least 10 pack years (P / Y) cigarette story in the case group
Exclusion Criteria:
- Being an active disease
- <18 years and> 45 years old
- Having used antibiotics in the last two weeks
- Use inhaler treatments
- Oral and salivary gland disease
- One week after menstrual bleeding in female cases
- Being in the luteal phase
- Menstrual irregularity
- Being pregnant
- Taking hormonal treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: smoking group
35 smoking case
|
At room temperature (18-25 ° C) the same place and standard environment will be done.
All involved cases will undergo a dental examination and within 30 minutes three samples of saliva will be taken, including first sample, after coffee drink and after drinking water.
The pH of samples will be measured and the smoking cessation rate of the smoking cigarette smoker with simultaneous VAS (VISUAL ANALOG SCALA) will be measured.
This data will be compared in-house and non-smoking control group
Other Names:
|
Other: nonsmoking group
35 nonsmoking case
|
At room temperature (18-25 ° C) the same place and standard environment will be done.
All involved cases will undergo a dental examination and within 30 minutes three samples of saliva will be taken, including first sample, after coffee drink and after drinking water.
The pH of samples will be measured and the smoking cessation rate of the smoking cigarette smoker with simultaneous VAS (VISUAL ANALOG SCALA) will be measured.
This data will be compared in-house and non-smoking control group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To investigate the changes in salivary pH after coffee consumption
Time Frame: 30 minutes after intervention
|
salivary pH measurement
|
30 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to investigate how drinking of water affect the smoking desire
Time Frame: 30 minutes after intervention
|
smoking desire will be assessed by visual analog scale with 1 is for minimum and 10 is for maximum desire for smoking
|
30 minutes after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 437-SBKAEK
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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