Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04032236
Other study ID # 437-SBKAEK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date January 31, 2019

Study information

Verified date July 2019
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

1. Not having an active disease

2. Be between the ages of 18 and 45

3. Not using antibiotics in the last two weeks

4. Do not use inhaler treatments

5. Not to have an oral or salivary gland disease

6. One week after menstrual bleeding in female cases

7. At least 10 pack years (P / Y) cigarette story in the case group

Exclusion Criteria:

1. Being an active disease

2. <18 years and> 45 years old

3. Having used antibiotics in the last two weeks

4. Use inhaler treatments

5. Oral and salivary gland disease

6. One week after menstrual bleeding in female cases

7. Being in the luteal phase

8. Menstrual irregularity

9. Being pregnant

10. Taking hormonal treatment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
caffeine
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

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the changes in salivary pH after coffee consumption salivary pH measurement 30 minutes after intervention
Secondary 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 30 minutes after intervention
See also
  Status Clinical Trial Phase
Completed NCT04133064 - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study N/A
Not yet recruiting NCT05442294 - "Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP) N/A
Completed NCT04104152 - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting N/A
Completed NCT04808609 - Smoking Cessation Pilot for People Living With HIV (PLWH) N/A
Enrolling by invitation NCT05554120 - The Next Step in Smoking Prevention: the Reduction of Tobacco Retail Outlets, a Comprehensive Policy Evaluation
Completed NCT05506046 - Messages About Reduced Nicotine in Combusted Tobacco Products N/A
Active, not recruiting NCT05950074 - It´s Up To You: Update and Digitalization of a Universal School-based Prevention Intervention for Drug Initiation and Use N/A
Completed NCT04089982 - Varenicline Light Smoking Pilot Phase 4
Completed NCT05460650 - Acceptance and Usability of an App Promoting Healthy Behaviours Amongst Young Women at Increased Risk of Breast Cancer N/A
Completed NCT05114863 - CSD200907: A Study to Assess Elements of Abuse Liability for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants N/A
Active, not recruiting NCT05049174 - Nurse-led Smoking Cessation Program With Follow-up in Healthy Life Centres: a Randomized Clinical Trial N/A
Completed NCT04372290 - CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products N/A
Completed NCT04358705 - C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH) N/A
Completed NCT04308434 - CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting N/A
Completed NCT04250727 - Switching to Potential Reduced Exposure Products in Adult Smokers N/A
Completed NCT04311983 - Interventions to Help More Low-income Smokers Quit N/A
Recruiting NCT06118502 - A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse N/A
Completed NCT05210699 - CSD201201: Study to Assess Elements of Abuse Liability for Electronic Nicotine Delivery System P12 N/A
Recruiting NCT05108649 - Impact of Nicotine Messaging on Beliefs and Behavior N/A
Active, not recruiting NCT05488743 - Smoking Prevention Program in Poland