NCT07158749

Brief Summary

Cigarette smoking remains common, particularly in rural areas, despite ample evidence that smoking causes cancer and respiratory disease. Successful smoking cessation yields the majority of its health benefits (e.g., avoidance of lung cancer) after years of sustained behavioral change; however, people who smoke cigarettes tend to show elevated rates of delay discounting (i.e., devaluation of delayed outcomes) and a bias for immediate gratification. The overall goal of this project is to develop different versions of an episodic future thinking intervention (i.e., visualization of the future) and test their feasibility and efficacy for smoking cessation in rural and urban populations.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2027

First Submitted

Initial submission to the registry

August 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

August 20, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

Cigarette smokingepisodic future thinking

Outcome Measures

Primary Outcomes (1)

  • Cigarettes smoked per day

    A timeline followback questionnaire will be used to assess the number of cigarettes smoked per day. Lower values reflect better outcomes.

    From Week 0 to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Other tobacco/nicotine product use per day

    From Week 0 to the end of treatment at 8 weeks

  • 7-day point prevalence cigarette abstinence

    Week 8

Other Outcomes (6)

  • Nicotine patch adherence (feasibility outcome)

    From Week 1 to the end of treatment at 8 weeks

  • Depressive symptoms (feasibility outcome)

    From Week 0 to the end of treatment at 8 weeks

  • Anxiety symptoms (feasibility outcome)

    From Week 0 to the end of treatment at 8 weeks

  • +3 more other outcomes

Study Arms (4)

Generalized episodic future thinking (EFT)

EXPERIMENTAL

The Generalized EFT group will identify positive events that may occur at 6 future time points (1 month to 5 years). These may include a broad range of personally significant milestones (e.g., weddings, birthdays) or other events that participants are looking forward to (e.g., spending time with loved ones). Participants will also generate vivid text descriptions, or cues (transcribed in their own words), to prompt EFT in the natural environment. These cues, including emotional impacts, will be elicited using standardized questions: Who are you with? What are you doing? Where are you? How are you feeling? Participants will be prompted to engage in Generalized EFT in the natural environment.

Behavioral: Episodic Future Thinking (EFT)Behavioral: Generalized episodic thinking

Domain-specific episodic future thinking (EFT)

EXPERIMENTAL

The Domain-Specific EFT group will complete an identical interview as the Generalized EFT group to identify positive future events, with one exception. Following initial cue generation, participants will be provided with descriptions of lung cancer symptoms (e.g., painful breathing; extreme fatigue; coughing up blood, phlegm, or mucus) and will be asked to visualize and include details related to this experience and their emotional impact in their revised cues. Thus, cancer-related symptoms occur in the context of otherwise positive, personally significant events to further highlight the impact of the diagnosis and to be consistent with Generalized EFT. Participants will be prompted to engage in Domain-Specific EFT in the natural environment.

Behavioral: Episodic Future Thinking (EFT)Behavioral: Domain-specific episodic thinking

Generalized episodic recent thinking (ERT)

PLACEBO COMPARATOR

The Generalized ERT interview will be identical to the one described for Generalized EFT, except participants will describe positive events they experienced in the last week. Participants will be prompted to engage in Generalized ERT in the natural environment.

Behavioral: Episodic Recent Thinking (ERT)Behavioral: Generalized episodic thinking

Domain-specific episodic recent thinking (ERT)

ACTIVE COMPARATOR

The Domain-Specific ERT interview will be identical to the one described for Domain-Specific EFT, except participants will describe positive events they experienced in the last week and will subsequently add detail as though they were experiencing symptoms of lung cancer. Participants will be prompted to engage in Domain-Specific ERT in the natural environment.

Behavioral: Episodic Recent Thinking (ERT)Behavioral: Domain-specific episodic thinking

Interventions

Participants will engage in EFT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.

Domain-specific episodic future thinking (EFT)Generalized episodic future thinking (EFT)

Participants will engage in ERT for 8 weeks, three times a day. Participants will receive three daily text messages. Each prompt will link to a custom web interface that guides participants to read and vividly imagine one of their cues, chosen randomly. Visit times and durations will be recorded.

Domain-specific episodic recent thinking (ERT)Generalized episodic recent thinking (ERT)

Content of the episodic thinking intervention will experiencing the symptoms of lung cancer during a broad range of personally meaningful, otherwise positive, events (e.g., social events, celebrations, spending times with friends and family).

Domain-specific episodic future thinking (EFT)Domain-specific episodic recent thinking (ERT)

Content of the episodic thinking intervention will include a broad range of personally meaningful, positive, events (e.g., social events, celebrations, spending times with friends and family).

Generalized episodic future thinking (EFT)Generalized episodic recent thinking (ERT)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoked cigarettes daily for the last 30 days;
  • salivary cotinine \> 30 ng/mL, consistent with tobacco use;
  • plan to quit smoking in the next 30 days

You may not qualify if:

  • prior diagnosis with a smoking-related illness (e.g., respiratory disease);
  • past 30-day use any smoking cessation treatment;
  • anxiety or mood disorders; and
  • medical contraindications for use of nicotine replacement therapy (e.g. pregnancy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24015, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco Use

Study Officials

  • Jeffrey Stein, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Stein, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 8, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All de-identified study data that are included in publication results will be shared using a project-specific url.

Shared Documents
SAP, ICF, ANALYTIC CODE
Time Frame
Study data and supporting information will be available beginning 3 months and ending 5 years after the publication of results.
Access Criteria
All shared deidentified study data and supporting information will be available without restriction via a project-specific url.

Locations