NCT05110612

Brief Summary

Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
12mo left

Started Jan 2050

Status
withdrawn

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

First Submitted

Initial submission to the registry

October 20, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
28.2 years until next milestone

Study Start

First participant enrolled

January 1, 2050

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2051

1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2051

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

October 20, 2021

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Loss aversion

    Loss aversion will be measured with a gamble task developed by Tom et al. (2007). Participants will choose whether to accept or reject each of a series of hypothetical lotteries offering a 50-50 chance of a monetary loss and a monetary gain. Participants will indicate their decision to play a lottery by clicking on accept or reject buttons (strongly accept, accept, reject, strongly reject) located on the screen below the amounts (Figure 2). The task will consist of a series of 49 trials presenting each combination of 7 possible gains (+$2, +$12, +$22, +$32, +$42, +$52, and +$62) and 7 possible losses (-$1, -$6, -$11, -$16, -$21, -$26, and -$31). Combinations of gains and losses will be presented in random order.

    30 days

  • Cigarette self-administration

    All participants will complete a 60-min self-administration task, in which they can earn single cigarette puffs for every 10 clicks on a moving circle on a computer screen. After completing each response requirement, participants will self-administer 1 cigarette puff. Target cigarette puff volume will be standardized at approximately 70 mL and participants will be instructed to light a cigarette without inhaling, place it in a cigarette holder connected to the pressure sensor, and inhale from the cigarette while estimated puff volume is displayed on the computer screen in real time. The displayed puff volume will turn from white to red at 60 ml and signal the approximate time participants should stop inhaling to reach 70 ml. Participants will have practiced this procedure prior to the task. Participants will be instructed that they can smoke as much or as little as they want during the task.

    30 days

Secondary Outcomes (1)

  • Delay discounting

    30 days

Study Arms (3)

Extended Episodic Future Thinking

EXPERIMENTAL

Participants will receive Episodic Future Thinking practice for 8 sessions.

Behavioral: Episodic Future Thinking

Brief Episodic Future Thinking

EXPERIMENTAL

Participants will receive Episodic Future Thinking practice for 2 sessions.

Behavioral: Episodic Future Thinking

Control

SHAM COMPARATOR

Participants will receive sham Episodic Recent Thinking intervention.

Behavioral: Control Episodic Thinking

Interventions

Episodic Future Thinking involves generating positive, autobiographical events that could realistically occur following each of five delays in the subsequent DD task: 1 day, 1 week, 1 month, 3 months, and 1 year. Participants will be told to not include events related specifically to smoking. Using a five-point Likert scale, participants will rate each event according to four dimensions: vividness, enjoyment, importance, and excitement. The event rated the most vivid at each time frame will be chosen for use in subsequent behavioral testing (ties will be settled randomly). Participants will then be recorded reciting a self-created two or three-sentence summary of each event. These recordings will serve as audio cues. Participants will also create abbreviated versions of each description to serve as text cues.

Brief Episodic Future ThinkingExtended Episodic Future Thinking

Control Episodic Thinking will report three real, positive events that occurred earlier in the session while playing mobile video games. Participants will be told to not include events related specifically to smoking. Using a five-point Likert scale, participants will rate each event according to four dimensions: vividness, enjoyment, importance, and excitement. The event rated the most vivid at each time frame will be chosen for use in subsequent behavioral testing (ties will be settled randomly). Participants will then be recorded reciting a self-created two or three-sentence summary of each event. These recordings will serve as audio cues. Participants will also create abbreviated versions of each description to serve as text cues.

Control

Eligibility Criteria

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

You may not qualify if:

  • Adult ≥ age 21 years.
  • Able to provide informed, written consent.
  • Smoke an average of at least five (5) cigarettes per day for at least one year.
  • Breath CO levels \> 8 ppm. If breath CO is less than 8 ppm, we will administer a urine test (NicAlert Strip) and include if result is greater than 2.
  • Desire to quit smoking, but not actively trying to quit or currently taking medications to aid smoking cessation (e.g, varenicline, bupropion).
  • US citizen or a permanent resident alien with a green card
  • Comfortable reading and writing in English
  • Currently seeking treatment for smoking cessation.
  • Use of tobacco products other than traditional combusted cigarettes on more than 9 of the previous 30 days
  • Positive urine toxicological screen for illicit drug use (i.e., amphetamine, methamphetamine, cocaine, barbiturates, benzodiazepines, buprenorphine, opiates, methadone, oxycodone, phencyclidine).
  • d) Breath alcohol level (BAL) at \<.01 (Alco-Sensor IV, Intoximeter, Inc., St Louis, MO) at intake.
  • a. Participants failing the toxicological screen will be allowed to re-screened for the study. These participants will complete the informed consent process an additional time before being re-screened.
  • e) Recent or current psychiatric episode to be determined with DSM-V criteria. f) Non-correctable vision or hearing impairments. g) Inability to independently read and comprehend written materials (consent form, other study materials and measures).
  • h) Currently pregnant (to be determined with a pregnancy test) or trying to become pregnant.
  • i) Currently breastfeeding. j) Exclusive use of "roll your own" cigarettes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Stein JS, Wilson AG, Koffarnus MN, Daniel TO, Epstein LH, Bickel WK. Unstuck in time: episodic future thinking reduces delay discounting and cigarette smoking. Psychopharmacology (Berl). 2016 Oct;233(21-22):3771-3778. doi: 10.1007/s00213-016-4410-y. Epub 2016 Aug 23.

    PMID: 27553824BACKGROUND
  • Tom SM, Fox CR, Trepel C, Poldrack RA. The neural basis of loss aversion in decision-making under risk. Science. 2007 Jan 26;315(5811):515-8. doi: 10.1126/science.1134239.

    PMID: 17255512BACKGROUND

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • ERIC A THRAILKILL, PHD

    University of Vermont

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized parallel group design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 8, 2021

Study Start (Estimated)

January 1, 2050

Primary Completion (Estimated)

January 1, 2051

Study Completion (Estimated)

January 2, 2051

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

During the study period data will be accessible only to University of Vermont Institutional Review Board-approved research personnel. After all participants complete the study, all data are collected, and the primary results have been published, de-identified data will be made available to other qualified investigators upon request and in a Open Science Foundation repository. Each request will be reviewed and evaluated individually by the PI to ensure that it meets reasonable demands of scientific integrity.

Shared Documents
STUDY PROTOCOL
Time Frame
Materials will be made available on a perpetual OSF repository after notice of publication.
Access Criteria
Open access