Cognitive and Affective Mechanisms Underlying an Olfactory Approach to Modify Cigarette Craving
Completed · Not applicable
Conditions studied: Craving
In brief
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.
Key facts
- Study ID
- NCT04902469
- Run by
- University of Pittsburgh
- People needed
- 232
- Starts
- 2021-12-01
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The University of Pittsburgh — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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