Episodic Future Thinking, Loss Aversion and Cigarette Smoking

Tobacco Smoking Clinical Trial

Official title:

Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05110612
• Other study ID #: FP00002058
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: February 2023
• Source: University of Vermont
• Contact: Eric A Thrailkill, PhD
• Phone: 802 656-2669
• Email: eric.thrailkill[@]uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 192
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion/Exclusion 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.

Related Conditions & MeSH terms

• Tobacco Smoking

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	30 days