NCT06191419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 5, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 8, 2026

Completed
Last Updated

July 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

December 20, 2023

Results QC Date

April 29, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

OdorsSensory perceptionNicotine addictionMotivation

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • Odor Pleasantness Score

    3 hours (total for all outcome measures)

Study Arms (1)

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.

Other: Odorants

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.

Participants that Smoke

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Smoker

You may not qualify if:

  • Non Smoker
  • Self reported inability to smell or taste

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Tobacco SmokingSmokingTobacco Use Disorder

Interventions

Odorants

Condition Hierarchy (Ancestors)

BehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Results Point of Contact

Title
Timothy McClintock
Organization
University of Kentucky

Study Officials

  • Timothy McClintock, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Each subject experiences and reports on all of the odor blocker and control treatments.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2023

First Posted

January 5, 2024

Study Start

April 5, 2024

Primary Completion

May 15, 2025

Study Completion

May 15, 2025

Last Updated

July 23, 2026

Results First Posted

July 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations