Actively Recruiting

Phase Not Applicable
Age: 18Years - 49Years
All Genders
NCT04902469

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

Led by University of Pittsburgh · Updated on 2025-07-03

250

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

Sponsors

U

University of Pittsburgh

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 49Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-49
  • Right-handed
  • Fluent in English
  • Intact sense of smell
  • Pass an MRI safety screening and weigh 250lbs or less
  • No drug dependence other than nicotine or caffeine
  • Daily smokers: smoke 10-30 cigarettes per day for at least 12 months
  • Nondaily smokers: smoke 1-14 days in the last 30 days with no more than 20 cigarettes per day
  • Access to a working smartphone for ecological momentary assessment
Not Eligible

You will not qualify if you...

  • Medical conditions that prevent nicotine use
  • Not fluent in English
  • Illiterate
  • Current neurological or psychotic disorders
  • Current use of psychoactive drugs
  • MRI contraindications such as stroke history, pregnancy, metal in the body, aneurysm history, or serious head injury
  • Allergies to odors used in the study
  • Baseline carbon monoxide readings inconsistent with smoking criteria (e.g., very heavy smokers with CO > 55 or daily smokers with CO < 10 PPM)

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Trial Site Locations

Total: 1 location

1

The University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15260

Actively Recruiting

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Research Team

M

Michael A Sayette, PhD

CONTACT

M

Marc N Coutanche, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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