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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Smoker

Exclusion Criteria

  • Non Smoker - Self reported inability to smell or taste

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Each subject experiences and reports on all of the odor blocker and control treatments.
Primary Purpose
Basic Science
Masking
None (Open Label)
Masking Description
Odor bags are prepared by one staff member and labeled with a code so that other investigators administering tests cannot identify which treatment is being given and inadvertently influence outcomes. The code is not visible to participants. This prevents participants from anticipating the effect of the treatment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants that Smoke
Each smoker is asked to smell up to 20 samples per session. Samples include controls (clean air, irrelevant odor), blocking odors, cigarette smoke, and cigarette smoke mixed with blocking odors or irrelevant odors.
  • Other: Odorants
    Each smoker is assigned a CPAP nose mask. Odor sample bags are attached to the mask. Smokers open the valve, inhale once through the nose, close the valve, remove the bag from the mask and report on the odor.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Timothy S McClintock
859-940-3364
mcclint@uky.edu

More Details

NCT ID
NCT06191419
Status
Recruiting
Sponsor
Tim McClintock

Study Contact

Timothy McClintock, PhD
8593231083
mcclint@uky.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.