NCT06283472

Brief Summary

The goal of this clinical trial is to test the prosocial effects of personally-relevant, high-intensity episodic future-thinking (EFT) cues in alcohol use disorder persons and related brain mechanisms. The main question\[s\] this trial aims to answer are:

  • Will high-intensity EFT cues will produce greater delayed reward preference than low-intensity cues?
  • Will high-intensity EFT cues effect greater treatment-seeking interest?
  • Will high-intensity EFT cues elicit greater response in regions for prospective thinking during delay discounting (vs. low-intensity)
  • Will nucleus accumbens-precuneus resting connectivity correlate with behavioral SS?
  • Will the novel behavioral SS decision-making task activate the nucleus accumbens? Researchers will compare the experimental (high-intensity group) and control (low-intensity) groups to see if there are differences in the results for the questions outlined above.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jun 2024Nov 2027

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

February 21, 2024

Last Update Submit

January 5, 2026

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use DisorderAlcohol AbuseHeavy DrinkingAlcohol

Outcome Measures

Primary Outcomes (2)

  • Increase Prospective Thinking

    High-intensity episodic future-thinking image cues will change prospective thinking.

    Study Day Visit (Day 1)

  • Delayed Rewards

    High-intensity episodic future-thinking image cues will change preference for delayed rewards, which will be measured using a behavioral delayed discounting task.

    Study Day Visit (Day 1)

Study Arms (2)

High-Intensity

EXPERIMENTAL

Participants will receive high-intensity episodic future-thinking cue images, and high-intensity episodic recent-thinking cue images during an MRI decision-making task.

Behavioral: High-Intensity Cue

Low-Intensity (Control)

ACTIVE COMPARATOR

Participants will receive low-intensity episodic future-thinking cue images, and low-intensity episodic recent-thinking cue images during an MRI decision-making task.

Behavioral: Low-Intensity Cue

Interventions

High-Intensity CueBEHAVIORAL

Participants in the high-intensity group will receive high-intensity image cues that represent self-reported events they did on the previous day and self-reported events they look forward to in the future.

High-Intensity
Low-Intensity CueBEHAVIORAL

Participants in the low-intensity group will receive low-intensity image cues that represent self-reported events they did on the previous day and self-reported events they look forward to in the future.

Low-Intensity (Control)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who meet current heavy drinking (≥2 heavy drinking days/month OR ≥7 drinks/week for biological females, and ≥14 drinks/week if biological male \[NIAAA definition\] and/or AUDIT scores ≥8)
  • English comprehension

You may not qualify if:

  • Unstable medical disorders
  • Outside the age range of 18-60
  • Smell/taste disorders
  • Unstable psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Medicine - Goodman Hall

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Eligible participants will be randomly assigned to either the high-intensity (experimental) or low-intensity (control) groups.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

June 17, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 7, 2026

Record last verified: 2025-12

Locations

US(1)