Cognitive and Affective Mechanisms Underlying an Olfactory Approach to Modify Cigarette Craving

Conditions

• Craving

Eligibility Criteria

Sex

ALL

Age

18 Years - 49 Years

Healthy Volunteers

Not accepted

Interventions

• Pleasant Odor — BEHAVIORAL
  Each participant in the pleasant odor condition will sniff an odor that they rated as the most intense out of a sample of odors rated to be pleasant. If this odor is the same as their self-reported preferred e-cigarette flavor, we will choose the next most intense odor out of the odors rated to be pleasant. Odors are generic and commercially available in supermarkets such as vanilla, coconut, and chocolate. Importantly, the investigators are not testing the specific odors, rather the participant's idiosyncratic response to a menu of odors. In other words, the key is that each participant in the experimental condition receives the odor that they like the best, regardless of which one it is.
• Odor Blank — BEHAVIORAL
  Each participant in the odor blank condition will sniff a neutral olfactory cue (odor blank). This involves a container with no added scent. This serves as the control condition.

Study Details

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 Dates

Start date

Dec 1, 2021

Status verified

Jul 2025

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Pleasant Odor
  Participants in this condition will sniff the olfactory cue they rate as both pleasant (\>5 on the 1-9 scale) and the most intense following cigarette cue exposure. If this odor is the same as their self-reported preferred e-cigarette flavor, we will choose the next most intense odor out of the odors rated as pleasant.
• Other: Odor Blank
  Participants in this condition will sniff a neutral olfactory cue (odor blank) following cigarette cue exposure.

Primary Outcome Measure

Disruption of the Craving Brain State by the Pleasant, Compared to the Neutral, Olfactory Cue [ Time Frame: within 1 month of enrollment; immediately before and after administration of the olfactory cue ]

Central Contacts

• Michael A Sayette, PhD
  412-624-8799
  [email protected]
• Marc N Coutanche, PhD
  (412) 624-7458
  [email protected]

Locations (1)

Find similar trials in Pittsburgh, PA

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