Evaluating the Episodic Future Thinking Intervention for Reducing Cigarette Consumption in Cigarette Smokers

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05825001
Collaborator
(none)
60
1
2
12
5

Study Details

Study Description

Brief Summary

This clinical trial evaluates the effectiveness of active episodic future thinking (EFT) stimuli for reducing cigarette consumption in cigarette smokers. EFT is an innovative framing method shown to significantly activate brain regions involved in future thinking, planning, and other executive functions. Active EFT stimuli are positive events, unrelated to smoking, that participants anticipate, look forward to, and can vividly imagine happening up to 1 year in the future. Control EFT stimuli are positive past events, unrelated to smoking, that participants can vividly remember happening in the recent past. Active EFT stimuli may help reduce cigarette consumption among cigarette smokers by exposing them to personally relevant future oriented stimuli.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smoking Cessation Intervention
  • Behavioral: Smoking Cessation Intervention (control)
  • Other: Medical Device Usage and Evaluation
N/A

Detailed Description

PRIMARY OBJEECTIVE:
  1. To evaluate the efficacy of episodic future thinking (EFT) for smoking cessation.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (ACTIVE): Participants receive the active EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

ARM II (CONTROL): Participants receive the control EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Pilot Study of Episodic Future Thinking Among Cigarette Smokers
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1 (active EFT)

Participants receive the active EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

Behavioral: Smoking Cessation Intervention
Receive active EFT stimulus
Other Names:
  • Smoking and Tobacco Use Cessation Interventions
  • Other: Medical Device Usage and Evaluation
    Use iCOquit Smokerlyzer carbon monoxide monitor

    Active Comparator: Arm II (control EFT)

    Participants receive the control EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.

    Behavioral: Smoking Cessation Intervention (control)
    Receive control EFT stimulus
    Other Names:
  • Smoking and Tobacco Use Cessation Interventions
  • Other: Medical Device Usage and Evaluation
    Use iCOquit Smokerlyzer carbon monoxide monitor

    Outcome Measures

    Primary Outcome Measures

    1. Reduction in cigarette consumption [From baseline up to 30 days]

      Will be measured by ICOquit Smokerlyzer

    Secondary Outcome Measures

    1. Reduction in delay discounting rate [Up to 30 days]

      participants will be guided to imagine the situational and sensory details for each of the stimuli until the vividness scores are ≥ 4 on a scale of 1-5 (1=very low, 5=very high).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Smoke >= 10 cigarettes daily

    • 32 on the Vividness of Visual Imagery Questionnaire (VVIQ)

    • No regular use of other tobacco products

    • In possession of a smartphone with text messaging capabilities

    Exclusion Criteria:
    • Unable or unwilling to provide verbal consent

    • Unable or unwilling to provide data to the research team

    • Current use of nicotine replacement therapy, bupropion, or varenicline

    • Use of drugs of abuse in the past 30 days

    • Living in the same household as a participant already enrolled in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Roswell Park Comprehensive Cancer Center Buffalo New York United States 14263

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Christine Sheffer, Roswell Park

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05825001
    Other Study ID Numbers:
    • I 2684022
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 24, 2023