Clinical trial NCT05110612: Episodic Future Thinking, Loss Aversion and Cigarette Smoking
Official title: Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel group design
Primary purpose: BASIC_SCIENCE

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Loss aversion
timeFrame: 30 days
measure: Cigarette self-administration
timeFrame: 30 days
Secondary outcomes:
measure: Delay discounting
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Vermont
name: ERIC A THRAILKILL, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.