Tobacco SmokingNCT05110612
Episodic Future Thinking, Loss Aversion and Cigarette Smoking
A study testing Episodic Future Thinking in people with Tobacco Smoking, run by University of Vermont.
Trial summary
Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Episodic Future Thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2050to 2 Jan 2051
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
- A positive test for marijuana (THC) will not result in exclusion from the study.
- Breath alcohol level (BAL) at <.01 (Alco-Sensor IV, Intoximeter, Inc., St Louis, MO) at intake.
- 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.
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- 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).
- Currently pregnant (to be determined with a pregnancy test) or trying to become pregnant.
- Currently breastfeeding. j) Exclusive use of "roll your own" cigarettes.
About this study
Official title: Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking
Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily.
Read the detailed description
Specific Aim 1: Examine in a controlled laboratory study using a randomized parallel-group design whether an intervention that increases LA among 138 current adult daily cigarette smokers (≥21 years; 50% male/50% female) also (1) decreases cigarette smoking and (2) can improve with practice and (3) sustain effectiveness at a follow-up assessment. Potential influence of DD, other self-control, and potential sociodemographic confounders will be accounted for in all analyses.
Hypothesis 1.1: EFT will increase LA and reduce cigarette smoking (i.e., smoking rate). (Primary) Hypothesis 1.2: Changes in LA will mediate the effect of EFT on cigarette smoking independent of changes in DD, and relevant self-control related factors. (Primary) Hypothesis 1.3: EFT effects will be greater following Extended compared to Brief training. (Secondary) Hypothesis 1.4: Changes in LA and smoking rate sustained at follow up will be mediated by EFT habit learning indexed by the perceived automaticity of cue generation with extended EFT practice. (Exploratory)
- Conditions
- Tobacco Smoking
- Being tested
- Episodic Future Thinking, Control Episodic Thinking
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episodic Future ThinkingBehavioural
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.
Control Episodic ThinkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Extended Episodic Future Thinking | Experimental | Participants will receive Episodic Future Thinking practice for 8 sessions. Receives: Behavioral: Episodic Future Thinking |
| Brief Episodic Future Thinking | Experimental | Participants will receive Episodic Future Thinking practice for 2 sessions. Receives: Behavioral: Episodic Future Thinking |
| Control | Sham comparator | Participants will receive sham Episodic Recent Thinking intervention. Receives: Behavioral: Control Episodic Thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days
Secondary outcomes (1)
Delay discounting
Delay discounting will be measured with a standard adjusting-amount task. This task used to measure intervention effects on delay discounting (e.g., Stein et al., 2016). At each of five delays, participants will choose between two different hypothetical amounts: $1,000.00 available after a delay or a smaller amount of money available immediately. The smaller amount will be titrated across six consecutive trials until reaching a point of subjective equality between choice options. Delays will be presented in random order. The value of the smaller amount at indifference indexes the discounted value of the larger option at each delay. This titration process will repeat at each of five delays: 1 day, 1 week, 1 month, 3 months, and 1 year.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2050 (estimated)
- Primary completion1 Jan 2051 (estimated)
- Study completion2 Jan 2051 (estimated)
Why it stopped: Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric A Thrailkill, University of Vermont
- Investigators
- ERIC A THRAILKILL, PHD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110612
- Sponsor's protocol ID
- FP00002058
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27553824Tom 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.
PubMed 17255512
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking
- ClinicalTrials.gov ID
- NCT05110612
- Acronym / sponsor ID
- FP00002058
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 1 Jan 2050 (estimated)
- Primary completion
- 1 Jan 2051 (estimated)
- Study completion
- 2 Jan 2051 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily.
Detailed description
Specific Aim 1: Examine in a controlled laboratory study using a randomized parallel-group design whether an intervention that increases LA among 138 current adult daily cigarette smokers (≥21 years; 50% male/50% female) also (1) decreases cigarette smoking and (2) can improve with practice and (3) sustain effectiveness at a follow-up assessment. Potential influence of DD, other self-control, and potential sociodemographic confounders will be accounted for in all analyses.
Hypothesis 1.1: EFT will increase LA and reduce cigarette smoking (i.e., smoking rate). (Primary) Hypothesis 1.2: Changes in LA will mediate the effect of EFT on cigarette smoking independent of changes in DD, and relevant self-control related factors. (Primary) Hypothesis 1.3: EFT effects will be greater following Extended compared to Brief training. (Secondary) Hypothesis 1.4: Changes in LA and smoking rate sustained at follow up will be mediated by EFT habit learning indexed by the perceived automaticity of cue generation with extended EFT practice. (Exploratory)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized parallel group design
| Arm | Type | Receives |
|---|---|---|
| Extended Episodic Future Thinking | Experimental | Behavioral: Episodic Future ThinkingParticipants will receive Episodic Future Thinking practice for 8 sessions. |
| Brief Episodic Future Thinking | Experimental | Behavioral: Episodic Future ThinkingParticipants will receive Episodic Future Thinking practice for 2 sessions. |
| Control | Sham comparator | Behavioral: Control Episodic ThinkingParticipants will receive sham Episodic Recent Thinking intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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).
- A positive test for marijuana (THC) will not result in exclusion from the study.
- Breath alcohol level (BAL) at <.01 (Alco-Sensor IV, Intoximeter, Inc., St Louis, MO) at intake.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episodic Future ThinkingEpisodic 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. | Behavioural | Brief Episodic Future Thinking, Extended Episodic Future Thinking |
| Control Episodic ThinkingControl 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. | Behavioural | Control |
Primary outcome
Loss aversion
Time frame: 30 days
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.
Cigarette self-administration
Time frame: 30 days
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.
1 secondary outcome
Delay discounting
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 27553824Stein 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.
- Background: PubMed 17255512Tom 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERIC A THRAILKILL, PHD principal investigator
University of Vermont
Questions about this trial
What is this clinical trial studying?
A study testing Episodic Future Thinking in people with Tobacco Smoking, run by University of Vermont.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss aversion (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110612, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.