Increasing the Temporal Window in Individuals With Alcohol Use Disorder

NCT04125238 | Completed Results DMC

• 2 other identifiers: RP1A / 20-015 / 22-358R01AA027381-01A1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

• 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.

  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)

• 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.

  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.

• 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

  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.

• 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

  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.

• 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).

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

Study Arms (2)

Episodic Future Thinking (EFT)

EXPERIMENTAL

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

Control Episodic Thinking (CET)

SHAM COMPARATOR

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

Episodic Future Thinking BEHAVIORAL

Participants will generate descriptions of vivid positive future events.

Also known as: EFT

Episodic Future Thinking (EFT)

Control Episodic Thinking BEHAVIORAL

Participants will generate descriptions of vivid positive recent past events.

Also known as: CET

Control Episodic Thinking (CET)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High-risk or harmful drinking (measured by AUDIT)
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: collaborator
• Carilion Clinic: collaborator
• University of Kentucky: collaborator
• Virginia Polytechnic Institute and State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• McMaster University: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Stephen LaConte
• Organization: Virginia Tech

slaconte@vtc.vt.edu

5405262008

Study Officials

• Stephen M LaConte, PhD

  Fralin Biomedical Research Institute at VTC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 14, 2019
• Study Start: November 13, 2020
• Primary Completion: August 28, 2024
• Study Completion: September 30, 2024
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon request after dissemination of results.
• Access Criteria: Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.

Locations

US (1)