Increasing the Temporal Window in Individuals With Alcohol Use Disorder

NCT ID: NCT04125238

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2024-09-30

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.

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Episodic Future Thinking

Intervention Type: BEHAVIORAL

Participants will generate descriptions of vivid positive future events.

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.

Group Type: SHAM_COMPARATOR

Control Episodic Thinking

Intervention Type: BEHAVIORAL

Participants will generate descriptions of vivid positive recent past events.

Interventions

Episodic Future Thinking

Participants will generate descriptions of vivid positive future events.

Intervention Type: BEHAVIORAL

Control Episodic Thinking

Participants will generate descriptions of vivid positive recent past events.

Intervention Type: BEHAVIORAL

Other Intervention Names

EFT; CET

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: collaborator

Carilion Clinic

OTHER

Sponsor Role: collaborator

University of Kentucky

OTHER

Sponsor Role: collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen M LaConte, PhD

Role: PRINCIPAL_INVESTIGATOR

Fralin Biomedical Research Institute at VTC

Locations

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R01AA027381-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RP1A / 20-015 / 22-358

Identifier Type: -

Identifier Source: org_study_id