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NCT04902469 · ClinicalTrials.gov registry record · NA

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

A NA study of Craving, sponsored by University of Pittsburgh.

Recruiting
Registry status
NA
Development phase
250
Enrollment target
1
Study location

NCT04902469: Recruiting NA study of Craving, sponsored by University of Pittsburgh.

NCT04902469 is a NA study of Craving that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 250 participants, roughly in line with the 237-participant average among 7 other Craving trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04902469, a NA study of Craving, is actively recruiting participants, sponsored by University of Pittsburgh.

RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

Condition difference in the Fisher Z-transformed correlation coefficient between the craving brain state and olfactory cue-induced brain state, where brain states are indexed as the fMRI contrast between cigarette cue (with, and without, odor) and control cue

Conditions Studied

Interventions

  • BEHAVIORAL Pleasant Odor
  • BEHAVIORAL Odor Blank

Study Locations (1)

Pennsylvania

  • The University of Pittsburgh - Pittsburgh

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2021-12-01
Est. Completion 2026-06
Phase NA
University of Pittsburgh

1,238 total trials

What NCT04902469 shows while recruiting

NCT04902469 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 237-participant average among 7 other Craving trials with a reported enrollment target.

The record links to 1 condition, with Craving appearing as the primary indexed condition, and to 2 interventions - of which Pleasant Odor is the first listed.

NCT04902469 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04902469 about?

NCT04902469 is a clinical study titled "Cognitive and Affective Mechanisms Underlying an Olfactory Approach to Modify Cigarette Craving". 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 bla...

What is the current status of trial NCT04902469?

This trial is currently recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-12-01. Estimated completion is 2026-06.

What conditions does trial NCT04902469 study?

This clinical trial studies the following conditions: Craving.

What interventions are being tested in trial NCT04902469?

The interventions under investigation include: Pleasant Odor (BEHAVIORAL), Odor Blank (BEHAVIORAL).

Who is sponsoring clinical trial NCT04902469?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04902469 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04902469, the US trial registry maintained by the National Library of Medicine. NCT04902469 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.