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CompletedNCT04125238RP1AUpdated Jan 23, 2026Results posted

Increasing the Temporal Window in Individuals With Alcohol Use Disorder

An interventional study of Episodic Future Thinking and Control Episodic Thinking in Alcohol Use Disorder, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

Episodic future thinking (EFT) is based on the new science of prospection, which was first identified in a Science publication in 2007 and refers to pre-experiencing the future by simulation. Considerable evidence suggests that prospection is important for understanding human cognition, affect, motivation, and action. Individuals with damaged frontal areas, as well as individuals with alcohol use disorder (AUD), show deficits in planning prospectively. One systematic method to engender prospection is via EFT. EFT, as applied in our prior studies and in this proposal consists of having participants develop positive plausible future events that correspond to several future time frames (e.g., 2 weeks, 1 month, 3 months etc). For each of these timeframes participants are asked to concretize the events (e.g., What are you doing? Who will be there? What will you see, hear, smell, and feel?). We and others have used EFT to decrease delay discounting (DD) in individuals with AUD and smokers, as well as normal weight, overweight, and obese populations when compared to the control condition, control episodic thinking (CET). Consistent with reinforcer pathology, EFT also reduces alcohol valuation in the purchase task among individuals with AUD. However, no study to date has examined whether EFT reduces alcohol self-administration in the laboratory. Moreover, the neural correlates of EFT in AUD are also unknown. In these studies, we propose to test an intervention, EFT, which we hypothesize will decrease reinforcer pathology measures in a bar-like setting in the laboratory; that is, EFT will decrease delay discounting, as well as alcohol self-administration, demand, and craving compared to a control episodic thinking (CET) condition. Moreover, we hypothesize EFT will enhance activation in brain regions associated with prospection (e.g., hippocampus and amygdala) and the executive decision system (e.g., DLPFC). We will also examine the effect of EFT on real-world drinking.

Read the detailed description

In study 1, participants will be randomly assigned to experimental or control groups, stratified by AUDIT scores, SES, age and sex. Based on our 8 years of experience recruiting this population, we expect approximately 66% retention among eligible participants. Therefore, we will enroll approximately 107 participants in order to conclude with 64 completers. Participants will complete: a baseline assessment (S1), an alcohol self-administration session (S2 or S3), an fMRI session (S2 or S3). The alcohol self-administration session and the fMRI session will be completed in counterbalanced order. At the beginning of S2 and S3, participants in both groups will be prompted to generate positive events and related cues through a researcher-administered interview-based questionnaire. EFT group participants will be asked to think about and describe the most positive event that could realistically happen at each of 7 delays in the future (1 day, 1 week, 1 month, 3 months, 1 year, 5 years, and 25 years). In contrast, participants randomized to the CET condition, will be asked to think about and describe the most positive event that occurred at each of 7 time points from the recent past (last night from 7pm-10pm, yesterday between 4pm-7pm, yesterday between 1pm-4pm, yesterday from 10am-12pm, yesterday between 7am-10am, the night before last between 7pm-10pm, and evening before last between 4pm-7pm). For each time point, the participant will be asked to integrate the event and sensory information into concise textual and/or auditory cues to be used in subsequent behavioral tasks. Cue generation will occur prior to both self administration and fMRI sessions (S2 and S3) to maximize the relevancy of cues at both sessions.

In study 2, participants will complete two sessions and undergo a one-week baseline monitoring phase where they provide breath samples to assess for recent alcohol use and report their drinks per day. Following this baseline period, participants will complete an fMRI then be randomized to either the EFT or Control group. Participants will then complete two weeks of monitoring, where they provide a breath sample three times a day and report the number of drinks they consumed. Participants will then come back to the lab to generate new EFT/CET cues, then complete two more weeks of monitoring. After conclusion of the second intervention period, participants will complete a post intervention session and then a one month follow up one month after study completion.

02

Conditions studied

  • Alcohol Use Disorder

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Keywords

  • Delay Discounting
  • Behavioral Economic Demand
  • Episodic Future Thinking
  • Self-Administration
  • Functional MRI
  • Alcohol Craving
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 328 are open to participants now.

This study's enrollment of 154 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • High-risk or harmful drinking (measured by AUDIT)
  • 21-65 years of age
  • Desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period
  • Report as one of their top three preferred drinks a beverage appropriate for the alcohol self-administration task (Study 1)

Exclusion criteria

Exclusion Criteria:

  • Moderate to severe DSM-5 criteria for substance-use disorders other than alcohol, nicotine, and/or marijuana
  • Current diagnosis of any psychotic disorder
  • History of seizure disorders or traumatic brain injury
  • Contraindication for participation in the self-administration (Study 1) or MRI sessions (Studies 1 and 2)
  • Current pregnancy or lactation.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    Episodic Future Thinking (EFT)

    Participants will generate positive future events they are looking forward to at five time points in the future (1 day, 1 week, 1 month, 3 months, 1 year, 5 years, and 25 years). Participants will be reminded of these events using cues throughout the study and instructed to think about these cues as they make their decisions.

    Behavioral: Episodic Future Thinking

  • Sham comparator
    Control Episodic Thinking (CET)

    Participants will generate positive recent past events that have happened to them at five time points in the recent past (last night from 7pm-10pm, yesterday between 4pm-7pm, yesterday between 1pm-4pm, yesterday from 10am-12pm, yesterday between 7am-10am, the night before last between 7pm-10pm, and evening before last between 4pm-7pm). Participants will be reminded of these events using cues throughout the study and instructed to think about these cues as they make their decisions.

    Behavioral: Control Episodic Thinking

Interventions

  • BehavioralEpisodic Future Thinking

    Participants will generate descriptions of vivid positive future events.

    Also known as: EFT

  • BehavioralControl Episodic Thinking

    Participants will generate descriptions of vivid positive recent past events.

    Also known as: CET

06

What researchers measure

Primary outcomes

  1. Delay Discounting (DD) Rates (Studies 1 and 2)

    DD rates were measured using an adjusting amount task where participants were presented with hypothetical choices between smaller immediate or larger later amounts of money after a range of delays (1 day-25 years). Individual indifference points were calculated for each delay and then used to estimate DD rates for each participant using Mazur's (1987) equation: V = A/(1+kD), where V is the value of the indifference point, A is the amount of the larger delayed reward, k is the discounting rate, and D is the delay. Discounting rates (k) were then natural-logarithmically transformed (ln(k)). Higher ln(k) indicates steeper discounting and greater reward devaluation with increases in delay, while a lower ln(k) reflects shallower discounting and less reward devaluation with increases in delay. Change in ln(k) will be compared within-subjects between S1 and S2, AND between S1 and S3.

    Time frame: Pre-intervention (S1; baseline measures; Day 1), Post 1st cue generation: S2 (occurs up to 7 days post S1 in Study 1 and 2-3 weeks post S1 in Study 2), and Post 2nd cue generation: S3 (occurs up to 7 days post S2 in Study 1 and 2 weeks post S2 in Study 2)

  2. Intensity of Alcohol Demand (Study 2)

    Participants completed a hypothetical Alcohol Purchase Task in which they indicated how many drinks they would purchase at different prices ($0 to $80 per drink). The number of drinks purchased at $0 was used to calculate the intensity of demand. Changes in intensity of alcohol demand were compared within-subjects between S1 and S2, AND between S1 and S3.

    Time frame: Pre-intervention (S1; baseline measure; Day 1), Post 1st cue generation, (S2; approximately 2 weeks post S1), and Post 2nd cue generation (S3; approximately 2 weeks post S2 and 4 weeks post S1)

  3. In-Laboratory Alcohol Consumption (Study 1)

    The number of alcoholic beverages purchased/consumed during the self-administration session will be recorded. The average number of drinks consumed will be compared between groups.

    Time frame: Self-Administration session will occur at either Session 2 or Session 3 based on counterbalance assignment. S2 occurs up to 7 days post S1 and S3 occurs up to 7 days post S2.

  4. fMRI Hyper-connectivity Decrease During Delay Discounting (Study 1)

    Measured using fMRI during delay discounting task. Whole-brain PPI analysis of right DLPFC between EFT and CET participants. We examined the number of participants whose Right DLPFC was negatively correlated with their Left DLPFC after the intervention. We hypothesize that AUD leads to hyperconnectivity (positive correlations) between these two regions as a compensatory decision-making mechanism, and that EFT should reduce or reverse this connectivity relationship

    Time frame: fMRI session occurred at either Session 2 or Session 3 based on counterbalance assignment. S2 occurred up to 7 days post S1 and S3 occurred up to 7 days post S2.

  5. fMRI Hyper-connectivity Decrease During Alcohol Purchase Task (Study 1)

    Measured using fMRI during the alcohol purchase task. Whole-brain PPI analysis of right DLPFC between EFT and CET participants. We examined the number of participants whose Right DLPFC was negatively correlated with their Left DLPFC after the intervention. We hypothesize that AUD leads to hyperconnectivity (positive correlations) between these two regions as a compensatory decision-making mechanism, and that EFT should reduce or reverse this connectivity relationship

    Time frame: fMRI session occurred at either Session 2 or Session 3 based on counterbalance assignment. S2 occurred up to 7 days post S1 and S3 occurred up to 7 days post S2.

  6. Change in Alcoholic Drinks Per Day (Study 2)

    Participants self-reported the number of drinks consumed per day via a mobile app during the first five weeks of the study. The first week measured baseline drinking (Pre-intervention), weeks 2-3 measured drinking after the first cue generation (Post 1st cue generation), and weeks 4-5 measured drinking after the second cue generation (Post 2nd cue generation) The number of drinks per day was compared within-subjects and between groups (EFT and CET).

    Time frame: Daily during Pre-intervention (week 1); Post 1st cue generation (weeks 2-3); and Post 2nd cue generation (weeks 4-5).

07

Results

Posted Jan 23, 2026

Participant flow

Participant flow — Overall Study
MilestoneEpisodic Future Thinking (EFT) - Study 1Control Episodic Thinking (CET) - Study 1Episodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2
Started20183430
Completed16122824
Not completed4666

Outcome measures

PrimaryDelay Discounting (DD) Rates (Studies 1 and 2)

DD rates were measured using an adjusting amount task where participants were presented with hypothetical choices between smaller immediate or larger later amounts of money after a range of delays (1 day-25 years). Individual indifference points were calculated for each delay and then used to estimate DD rates for each participant using Mazur's (1987) equation: V = A/(1+kD), where V is the value of the indifference point, A is the amount of the larger delayed reward, k is the discounting rate, and D is the delay. Discounting rates (k) were then natural-logarithmically transformed (ln(k)). Higher ln(k) indicates steeper discounting and greater reward devaluation with increases in delay, while a lower ln(k) reflects shallower discounting and less reward devaluation with increases in delay. Change in ln(k) will be compared within-subjects between S1 and S2, AND between S1 and S3.

Time frame:
Pre-intervention (S1; baseline measures; Day 1), Post 1st cue generation: S2 (occurs up to 7 days post S1 in Study 1 and 2-3 weeks post S1 in Study 2), and Post 2nd cue generation: S3 (occurs up to 7 days post S2 in Study 1 and 2 weeks post S2 in Study 2)
Reported as:
Mean · ln(K-value)
Delay Discounting (DD) Rates (Studies 1 and 2)
ln(K-value)Episodic Future Thinking (EFT) - Study 1Control Episodic Thinking (CET) - Study 1Episodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2
Pre-intervention-5.33 ± 0.44-6.03 ± 0.41-4.94 ± 0.44-5.79 ± 0.49
Post 1st cue gen-6.72 ± 0.65-5.94 ± 0.55-6.41 ± 0.39-5.1 ± 0.45
Post 2nd cue gen-6.61 ± 0.50-5.75 ± 0.38-6.54 ± 0.40-5.28 ± 0.59
PrimaryIntensity of Alcohol Demand (Study 2)

Participants completed a hypothetical Alcohol Purchase Task in which they indicated how many drinks they would purchase at different prices ($0 to $80 per drink). The number of drinks purchased at $0 was used to calculate the intensity of demand. Changes in intensity of alcohol demand were compared within-subjects between S1 and S2, AND between S1 and S3.

Time frame:
Pre-intervention (S1; baseline measure; Day 1), Post 1st cue generation, (S2; approximately 2 weeks post S1), and Post 2nd cue generation (S3; approximately 2 weeks post S2 and 4 weeks post S1)
Reported as:
Mean · Drinks
Intensity of Alcohol Demand (Study 2)
DrinksEpisodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2
S111.19 ± 5.9815.04 ± 9.79
S211.22 ± 7.2314.27 ± 6.81
S310.87 ± 7.1714.65 ± 10.14
PrimaryIn-Laboratory Alcohol Consumption (Study 1)

The number of alcoholic beverages purchased/consumed during the self-administration session will be recorded. The average number of drinks consumed will be compared between groups.

Time frame:
Self-Administration session will occur at either Session 2 or Session 3 based on counterbalance assignment. S2 occurs up to 7 days post S1 and S3 occurs up to 7 days post S2.
Reported as:
Mean · Drinks
In-Laboratory Alcohol Consumption (Study 1)
DrinksEpisodic Future Thinking (EFT)Control Episodic Thinking (CET)
In-Laboratory Alcohol Consumption (Study 1)4.81 ± 2.815.25 ± 3.22
PrimaryfMRI Hyper-connectivity Decrease During Delay Discounting (Study 1)

Measured using fMRI during delay discounting task. Whole-brain PPI analysis of right DLPFC between EFT and CET participants. We examined the number of participants whose Right DLPFC was negatively correlated with their Left DLPFC after the intervention. We hypothesize that AUD leads to hyperconnectivity (positive correlations) between these two regions as a compensatory decision-making mechanism, and that EFT should reduce or reverse this connectivity relationship

Time frame:
fMRI session occurred at either Session 2 or Session 3 based on counterbalance assignment. S2 occurred up to 7 days post S1 and S3 occurred up to 7 days post S2.
Reported as:
Count of participants · Participants
fMRI Hyper-connectivity Decrease During Delay Discounting (Study 1)
ParticipantsEpisodic Future Thinking (EFT)Control Episodic Thinking (CET)
fMRI Hyper-connectivity Decrease During Delay Discounting (Study 1)140
PrimaryfMRI Hyper-connectivity Decrease During Alcohol Purchase Task (Study 1)

Measured using fMRI during the alcohol purchase task. Whole-brain PPI analysis of right DLPFC between EFT and CET participants. We examined the number of participants whose Right DLPFC was negatively correlated with their Left DLPFC after the intervention. We hypothesize that AUD leads to hyperconnectivity (positive correlations) between these two regions as a compensatory decision-making mechanism, and that EFT should reduce or reverse this connectivity relationship

Time frame:
fMRI session occurred at either Session 2 or Session 3 based on counterbalance assignment. S2 occurred up to 7 days post S1 and S3 occurred up to 7 days post S2.
Reported as:
Count of participants · Participants
fMRI Hyper-connectivity Decrease During Alcohol Purchase Task (Study 1)
ParticipantsEpisodic Future Thinking (EFT)Control Episodic Thinking (CET)
fMRI Hyper-connectivity Decrease During Alcohol Purchase Task (Study 1)00
PrimaryChange in Alcoholic Drinks Per Day (Study 2)

Participants self-reported the number of drinks consumed per day via a mobile app during the first five weeks of the study. The first week measured baseline drinking (Pre-intervention), weeks 2-3 measured drinking after the first cue generation (Post 1st cue generation), and weeks 4-5 measured drinking after the second cue generation (Post 2nd cue generation) The number of drinks per day was compared within-subjects and between groups (EFT and CET).

Time frame:
Daily during Pre-intervention (week 1); Post 1st cue generation (weeks 2-3); and Post 2nd cue generation (weeks 4-5).
Reported as:
Mean · Drinks/day
Change in Alcoholic Drinks Per Day (Study 2)
Drinks/dayEpisodic Future Thinking (EFT)Control Episodic Thinking (CET)
Pre-Intervention5.6 ± 0.415.3 ± 0.42
Post 1st cue generation5.0 ± 0.424.9 ± 0.43
Post 2nd cue generation4.3 ± 0.375.4 ± 0.62

Adverse events

Collected over During study participation (up to 14 days in Study 1, and 35 days in Study 2). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Episodic Future Thinking (EFT) - Study 10/20 (0%)0/20 (0%)0/20 (0%)
Control Episodic Thinking (CET) - Study 10/18 (0%)0/18 (0%)0/18 (0%)
Episodic Future Thinking (EFT) - Study 20/34 (0%)0/34 (0%)0/34 (0%)
Control Episodic Thinking (CET) - Study 20/30 (0%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Episodic Future Thinking (EFT) - Study 1Control Episodic Thinking (CET) - Study 1Episodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2Total
Mean35.7 ± 8.9542.4 ± 12.9639.74 ± 13.5235.7 ± 12.3539.3 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)Episodic Future Thinking (EFT) - Study 1Control Episodic Thinking (CET) - Study 1Episodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2Total
Female68121339
Male1410221763
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Episodic Future Thinking (EFT) - Study 1Control Episodic Thinking (CET) - Study 1Episodic Future Thinking (EFT) - Study 2Control Episodic Thinking (CET) - Study 2Total
Hispanic or Latino10225
Not Hispanic or Latino1918322897
Unknown or Not Reported00000
08

Study locations

1 site
  • Fralin Biomedical Research Institute at VTC
    Roanoke, Virginia 24016, United States
09

References and documents

Study documents

  • Study protocol · Oct 16, 2024
  • Statistical analysis plan · Jun 6, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Investigators will adhere to all NIH requirements regarding data sharing. Participant data collected in this project will be de-identified and made available on a shared secured data repository. We will also share the analysis results. As part of this process, all investigators will be required to agree to the following conditions: 1) will adhere to the reporting responsibilities; 2) will not redistribute the data beyond the requesting individual and named collaborators; 3) will give appropriate acknowledgement; 4) will not use the data for commercial purposes; and 5) will obtain appropriate ethical approvals. Results from research conducted will be shared and disseminated, including: regular project meetings, annual meetings, symposia, workshops, and/or conferences for related groups. Manuscripts will be written and submitted for publication in peer-reviewed journals/conferences, following the NIH Public Access Policy guidelines. All necessary ethical approvals will be obtained.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04125238
Lead sponsor
Virginia Polytechnic Institute and State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), McMaster University, Arizona State University, Carilion Clinic, University of Kentucky
Responsible party
Sponsor
First posted
Oct 14, 2019
Start date
Nov 13, 2020
Primary completion
Aug 28, 2024
Completion
Sep 30, 2024
Results posted
Jan 23, 2026
Last update
Jan 23, 2026

Study contacts

Stephen M LaConte, PhD
principal investigator · Fralin Biomedical Research Institute at VTC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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