Smoking BehaviorsNCT04032236
Effect of Oral pH Changes on Smoking Desire
A study testing caffeine in people with Smoking Behaviors, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Being in the luteal phase
- Menstrual irregularity
- Being pregnant
- Taking hormonal treatment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Smoking Behaviors
- Being tested
- caffeine
- Keywords
- caffeine, nicotin, pH
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeineOther
Also called water
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
| Study group | Role | What they receive |
|---|---|---|
| smoking group | Other | 35 smoking case Receives: Other: caffeine |
| nonsmoking group | Other | 35 nonsmoking case Receives: Other: caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the changes in salivary pH after coffee consumption
salivary pH measurement
Measured: 30 minutes after intervention
Secondary outcomes (1)
to investigate how drinking of water affect the smoking desire
smoking desire will be assessed by visual analog scale with 1 is for minimum and 10 is for maximum desire for smoking
Measured: 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Jun 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case-control
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Ergan, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032236
- Sponsor's protocol ID
- 437-SBKAEK
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral pH Changes on Smoking Desire
- ClinicalTrials.gov ID
- NCT04032236
- Acronym / sponsor ID
- 437-SBKAEK
- Conditions
- Smoking Behaviors
- Keywords
- caffeine, nicotin, pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- case-control
| Arm | Type | Receives |
|---|---|---|
| smoking group | Other | Other: caffeine35 smoking case |
| nonsmoking group | Other | Other: caffeine35 nonsmoking case |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| caffeineAlso: waterAt 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 | nonsmoking group, smoking group |
Primary outcome
To investigate the changes in salivary pH after coffee consumption
Time frame: 30 minutes after intervention
salivary pH measurement
1 secondary outcome
to investigate how drinking of water affect the smoking desire
Time frame: 30 minutes after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine in people with Smoking Behaviors, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the changes in salivary pH after coffee consumption (time frame: 30 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.