- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110612
Episodic Future Thinking, Loss Aversion and Cigarette Smoking
Episodic Future Thinking Intervention Targeting Loss Aversion and Cigarette Smoking
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion/Exclusion Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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. 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control
Participants will receive sham Episodic Recent Thinking intervention.
|
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.
|
|
Experimental: Extended Episodic Future Thinking
Participants will receive Episodic Future Thinking practice for 8 sessions.
|
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.
|
|
Experimental: Brief Episodic Future Thinking
Participants will receive Episodic Future Thinking practice for 2 sessions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 days
|
|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Delay discounting
Time Frame: 30 days
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ERIC A THRAILKILL, PHD, University of Vermont
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP00002058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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