Smoking Behaviors, Tobacco Smoking
Conditions
Keywords
Odors, Sensory perception, Nicotine addiction, Motivation
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 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).
Interventions
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.
Sponsors
Study design
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.
Intervention model description
Each subject experiences and reports on all of the odor blocker and control treatments.
Eligibility
Inclusion criteria
* Smoker
Exclusion criteria
* Non Smoker * Self reported inability to smell or taste
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette Purchase Task | 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. |
| Desire to Smoke | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Odor Pleasantness Score | 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. |
Countries
United States
Contacts
University of Kentucky
Participant flow
Pre-assignment details
All participants assessed for eligibility were enrolled and started the study procedures.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |