Clinical trial NCT06191419: Human Perception of Odors and Odor Blockers
Official title: Human Perception of Odors and Odor Blockers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Smoking Behaviors
Keywords: Odors
Sensory perception
Nicotine addiction
Motivation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each subject experiences and reports on all of the odor blocker and control treatments.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to determine whether blockers of perception of key odorants in cigarette smoke have any utility in smoking cessation. The main question it aims to answer is:

• Can odor blockers be used to suppress perception of the intensity of cigarette smoke in ways that reduce the ability of the odor of cigarette smoke to increase the urge to smoke.

Participants will be asked to smell up to 20 odor samples per session and report on odor pleasantness and desire to smoke.

Detailed description: The experimental treatments include controls (clean air, irrelevant odor), blocking odors, cigarette smoke odor, and cigarette smoke odor mixed with blocking odors or irrelevant odor. To obtain cigarette smoke odor a 1 inch length of a 1R6F research cigarette is burned to completion in a sealed 5 gallon chamber fitted with septa. Using a syringe fit with a needle and filter, 60 mL aliquots of smoke odor are obtained. These smoke odor aliquots, along with blocking odors, are injected into odor sample bags fit with a septum and a valve that can be attached to the CPAP nose mask worn by each participating smoker. Participants open the valve, inhale once through the nose, close the valve, and then remove the bag from the mask before reporting odor pleasantness and the desire to smoke. A 2 - 3 min wait period is enforced between each odor presentation to prevent odor adaptation and to allow acute motivational effects to subside.

In a testing session a participant sniffs 4 concentrations of a mixture of 2 blocking odors, along with control odor samples. Presentation order is randomized. Each participant is assigned their own CPAP nose mask, and masks are disinfected after use. Participants also provide demographic (age, sex, ethnic and racial background) and smoking history information (cigarettes per day, preferred brand, age at onset, and time since last cigarette).

Eligibility criteria: Inclusion Criteria:

* Smoker

Exclusion Criteria:

* Non Smoker
* Self reported inability to smell or taste

Primary outcomes:
measure: Cigarette Purchase Task
timeFrame: 3 hours (total for all outcome measures)
measure: Desire to Smoke
timeFrame: 3 hours (total for all outcome measures)
Secondary outcomes:
measure: Odor pleasantness score
timeFrame: 3 hours (total for all outcome measures)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Timothy McClintock, PhD
role: PRINCIPAL_INVESTIGATOR
References: