NCT04902469 Cognitive and Affective Mechanisms Underlying an Olfactory Approach to Modify Cigarette Craving
| NCT ID | NCT04902469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Craving |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2021-12-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed study uses fMRI and behavioral measures in and outside the laboratory to investigate the neurobehavioral mechanisms underlying the impact of pleasant olfactory cues (OCs) on cigarette craving. The investigators plan to randomize 278 participants to a pleasant OC condition or an odor blank (neutral) condition and due to anticipated drop out expect to run 250 adult (half female) smokers, including both daily and nondaily smokers through the protocol. This study involves three visits. In the first visit, participants will complete a baseline breath carbon monoxide reading, a brief odor threshold test, and complete a series of self-report measures. In the next session, participants who are 8-hrs deprived of nicotine will undergo a 60-minute fMRI scan that will include structural, resting state, and task-based data collection. The fMRI task involves completing a series of tasks designed to index responses linked to key neural networks found to relate to addiction (e.g., reward processing, working memory). Participants will also be exposed to smoking cues to heighten craving and then depending on their condition (randomly assigned) will either receive a pleasant or neutral (odor blank) OC. In the third session, behavioral data will be collected to test the impact of either a pleasant or neutral OC on cigarette craving using self-reported urge and behavioral measures linked to craving. Finally, for pilot purposes designed to offer data for a subsequent clinical study (beyond this study), participants will additionally complete a 7-day ecological momentary assessment (EMA) protocol in which they will monitor cigarette craving and initial data will be collected outside the laboratory to evaluate the impact of OCs on naturally occurring craving. It is hypothesized that pleasant OCs will disrupt craving brain states and attenuate craving (as compared to neutral olfactory cues). Further, it is hypothesized that individual variation in neural responses to cognitive and affective tasks will reveal variation in mechanisms underlying pleasant OC craving reduction and that individual differences will moderate pleasant OC-induced craving relief. Finally, it is also expected that emotional responses to pleasant OCs will mediate the impact of OCs on craving and smoking-related processes.
Eligibility Criteria
Inclusion Criteria: * Aged 18-49 * Right-handed * Fluent in English * Intact sense of smell * Pass an MRI safety screening and along these lines will need to be 250lbs or less to safely enter the MRI * No drug dependence outside of nicotine or caffeine * Must fit into one of two categories of smokers, daily or nondaily, as confirmed by verbal self-report and a baseline CO reading; Daily smokers: must smoke 10-30 cigarettes per day for at least 12 months, Nondaily smokers: must smoke for 1-14 days of the last 30 days with no more than 20 cigarettes a day * Need to have access to a working smartphone to complete the ecological momentary assessment portion of the study Exclusion Criteria: * Medical conditions that contraindicate nicotine use * Not fluent in English * Illiterate * Current neurological or psychotic disorders * Current psychoactive drug use * MRI contraindications such as stroke history, pregnancy, metal in the body, history of aneurysms, or serious head injury * Individuals will also be excluded if they report any allergies to the odors used in our study. * Baseline CO readings will need to be consistent with our criteria for daily and nondaily smokers for participants to be considered eligible. Specifically, we plan to rule out extremely heavy smokers (nondeprived CO \> 55, for whom the smoking abstinence requirement may be too extreme to allow a sensitive test of our OC manipulation) and daily smokers with a nondeprived CO reading \<10 PPM as this would raise concerns that they do smoke enough to be classified as a daily smoker.
Contact & Investigator
Michael A Sayette, PhD
PRINCIPAL INVESTIGATOR
The University of Pittsburgh
Frequently Asked Questions
Who can join the NCT04902469 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Craving. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04902469 currently recruiting?
Yes, NCT04902469 is actively recruiting participants. Contact the research team at sayette@pitt.edu for enrollment information.
Where is the NCT04902469 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04902469 clinical trial?
NCT04902469 is sponsored by University of Pittsburgh. The principal investigator is Michael A Sayette, PhD at The University of Pittsburgh. The trial plans to enroll 250 participants.