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

Pilot Study of Episodic Future Thinking Among Cigarette Smokers

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Behavioral: Smoking Cessation Intervention; Other: Medical Device Usage and Evaluation; Behavioral: Smoking Cessation Intervention (control)

Detailed Description

PRIMARY OBJEECTIVE:

I. 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 Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Sheffer; Phone Number: 716-845-1186; Email: Christine.Sheffer@roswellpark.org

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Recruiting
      • Roswell Park Comprehensive Cancer Center
      • Contact: Christine Scheffer; Phone Number: 716-845-1186; Email: Christine.Sheffer@roswellpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

  • Willing to quit smoking in the next 30 days
  • Low socioeconomic status

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of carbon monoxide on breath	Will be measured by ICOquit Smokerlyzer	From baseline up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in delay discounting rate	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).	Up to 30 days

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Christine Sheffer, Roswell Park

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 22, 2025
• Study Completion (Estimated): February 22, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: I 2684022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No