Episodic Future Thinking, Loss Aversion and Cigarette Smoking

NCT ID: NCT05110612

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2028-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Extended Episodic Future Thinking

Participants will receive Episodic Future Thinking practice for 8 sessions.

Group Type: EXPERIMENTAL

Episodic Future Thinking

Intervention Type: BEHAVIORAL

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 Thinking

Participants will receive Episodic Future Thinking practice for 2 sessions.

Group Type: EXPERIMENTAL

Episodic Future Thinking

Intervention Type: BEHAVIORAL

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

Participants will receive sham Episodic Recent Thinking intervention.

Group Type: SHAM_COMPARATOR

Control Episodic Thinking

Intervention Type: BEHAVIORAL

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.

Interventions

Episodic Future Thinking

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.

Intervention Type: BEHAVIORAL

Control Episodic 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Adult ≥ age 21 years.

2. Able to provide informed, written consent.

3. Smoke an average of at least five (5) cigarettes per day for at least one year.

4. 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.

5. Desire to quit smoking, but not actively trying to quit or currently taking medications to aid smoking cessation (e.g, varenicline, bupropion).

6. US citizen or a permanent resident alien with a green card

7. Comfortable reading and writing in English

Exclusion Criteria

1. Currently seeking treatment for smoking cessation.

2. Use of tobacco products other than traditional combusted cigarettes on more than 9 of the previous 30 days

3. Positive urine toxicological screen for illicit drug use (i.e., amphetamine, methamphetamine, cocaine, barbiturates, benzodiazepines, buprenorphine, opiates, methadone, oxycodone, phencyclidine).

a. A positive test for marijuana (THC) will not result in exclusion from the study.

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Eric A Thrailkill

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ERIC A THRAILKILL, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Central Contacts

Eric A Thrailkill, PhD

Role: CONTACT

eric.thrailkill@uvm.edu

802 656-2669

References

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.

Reference Type: BACKGROUND

PMID: 27553824 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17255512 (View on PubMed)

Other Identifiers

FP00002058

Identifier Type: -

Identifier Source: org_study_id