University of Kentucky
Lexington, Kentucky, 40536, United States
NCT Number: NCT06191419
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Lexington, Kentucky, 40536, United States
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 4 min wait period is enforced between each odor presentation to prevent odor adaptation and to allow acute motivational effects to subside. During these intervals, a nature documentary was available for viewing. Two measures of the desire to smoke are made. An objective method uses a validated relative reinforcing measure, requiring participants to record how many cigarettes they would purchase at each step along a logarithmically increasing price scale that ranges from $0 to $1,120 per cigarette. The breakpoint on this scale at which a participant is no longer willing to pay is the measure of the urge to smoke. As a subjective measure, participants report their urge to smoke as a value between 0 and 100. Participants also provide a forced choice measure of odor pleasantness, indicating either pleasant or unpleasant for each odor.
In a testing session a participant sniffs a mixture of blocking odors mixed with cigarette smoke, 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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 hours (total for all outcome measures)
The Cigarette Purchase Task (Strickland et al., 2016) requires selecting how much the smoker is willing to spend for a single cigarette (their preferred brand) from a list of 19 amounts ranging from $0.00 (free) to $1,120. The measure from the selections is the breakpoint where the participants are no longer willing to purchase. These data are skewed and are log transformed (after adding 0.01) for statistical analysis.
Time frame: 3 hours (total for all outcome measures)
A rating of participant's desire to smoke on a scale of 0 - 100, where a higher score indicates increased desire.
Time frame: 3 hours (total for all outcome measures)
Participants complete a forced-choice test by rating whether the odor is pleasant or unpleasant. Responses were recorded as a binary measure where 0=unpleasant and 1=pleasant. Scores range from 0 to 1, with higher score indicate greater odor pleasantness.
Tim McClintock
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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