NCT04032236

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

July 19, 2019

Last Update Submit

July 24, 2019

Conditions

Keywords

caffeinenicotinpH

Outcome Measures

Primary Outcomes (1)

  • To investigate the changes in salivary pH after coffee consumption

    salivary pH measurement

    30 minutes after intervention

Secondary Outcomes (1)

  • to investigate how drinking of water affect the smoking desire

    30 minutes after intervention

Study Arms (2)

smoking group

OTHER

35 smoking case

Other: caffeine

nonsmoking group

OTHER

35 nonsmoking case

Other: caffeine

Interventions

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

Also known as: water
nonsmoking groupsmoking group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking

Interventions

CaffeineWater

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: case-control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

July 19, 2019

First Posted

July 25, 2019

Study Start

June 1, 2018

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

July 26, 2019

Record last verified: 2019-07

Locations