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| ID | Type | Description | Link |
|---|---|---|---|
| 1K18DC020155 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants that Smoke | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odorants | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette Purchase Task | 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. | 3 hours (total for all outcome measures) |
| Desire to Smoke | A rating of participant's desire to smoke on a scale of 0 - 100, where a higher score indicates increased desire. | 3 hours (total for all outcome measures) |
| Measure | Description | Time Frame |
|---|---|---|
| Odor Pleasantness Score | 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. | 3 hours (total for all outcome measures) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy McClintock, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
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All participants assessed for eligibility were enrolled and started the study procedures.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cigarette Purchase Task | 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. | Posted | Mean | Standard Deviation | Log (US Dollars) | 3 hours (total for all outcome measures) |
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During the single study session
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy McClintock | University of Kentucky | 8593231083 | mcclint@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2026 | Apr 29, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 5, 2025 | Jul 2, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D009812 | Odorants |
| ID | Term |
|---|---|
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |
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Each subject experiences and reports on all of the odor blocker and control treatments.
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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.
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Desire to Smoke | A rating of participant's desire to smoke on a scale of 0 - 100, where a higher score indicates increased desire. | Posted | Mean | Standard Deviation | score on a scale | 3 hours (total for all outcome measures) |
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| Secondary | Odor Pleasantness Score | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 hours (total for all outcome measures) |
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| 27 |
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| D001523 |
| Mental Disorders |
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| Cigarette Smoke and Pentanethiol |
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| Cigarette Smoke and Mineral Oil |
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| Cigarette Smoke and Pentanethiol |
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| Cigarette Smoke and Mineral Oil |
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