NCT07788716

Brief Summary

The goal of this clinical trial is to evaluate changes in craving and sensory responses to different beverage cues in adults (aged 21-70) with current mild or greater alcohol use disorder (AUD). The main questions it aims to answer are:

  • Does exposure to different beverage cues elicit distinct changes in subjective craving?
  • How do beverage liking, peak craving, and the return of craving to baseline compare across different test-beverage conditions? Researchers will compare Session A (Test Beverage Condition A) to Session B (Test Beverage Condition B) in a randomized crossover design to see if sensory and expectancy effects influence craving responses without consumption. Participants will:
  • Complete two separate 3-minute cue reactivity trials per session (a baseline water cue, followed by a test-beverage cue) while listening to guided audio instructions and holding/smelling the beverage without drinking it.
  • Rate their craving and beverage liking using visual analog scales (VAS) immediately after each trial.
  • Provide breathalyzer readings (BrAC), vital signs, and safety/medication checks at both study visits.
  • Complete diagnostic and drinking history assessments (such as the SCID-5, TLFB, and ACQ-SF-R).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Oct 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 20, 2026

Last Update Submit

August 24, 2026

Conditions

Alcohol Use Disorder (AUD)

Keywords

AUDAlcohol Use DisorderCue Reactivity

Outcome Measures

Primary Outcomes (1)

  • Change in Subjective Alcohol Craving Score, Visual Analog Scale (VAS)

    Change in subjective alcohol craving, measured using a 20-cm Visual Analog Scale (VAS) ranging from 0 ("strongly disagree" or "None") to 20 ("Strongly agree" or "Extremely strong"), with higher scores indicating greater craving. Craving will be compared following a water cue versus a visually matched test-beverage cue.

    Visit 1 (baseline) through Visit 2, an average of 1 week.

Secondary Outcomes (1)

  • Beverage Liking Rating, Visual Analog Scale (VAS)

    Visit 1 (baseline) through Visit 2, an average of 1 week

Study Arms (2)

Beverage A

EXPERIMENTAL

Exposure to a visually matched beverage to Beverage B

Behavioral: Alcohol Cue Reactivity Paradigm

Beverage B

EXPERIMENTAL

Exposure to a visually matched beverage to Beverage A

Behavioral: Alcohol Cue Reactivity Paradigm

Interventions

Alcohol Cue Reactivity ParadigmBEHAVIORAL

Standardized 3-minute visual, olfactory, and tactile exposure to beverage cues (water, and two similar appearing beverages) accompanied by guided audio instructions.

Beverage ABeverage B

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-70 years.
  • Current AUD (mild or greater severity on the SCID-5).
  • Regular drinkers (at least one drink in past week as identified in TLFB) able to identify a preferred alcoholic beverage (e.g., beer, wine, spirits, or mixed) for which a visually matched non-alcoholic alternative exists and can be sourced .
  • Willing to abstain from alcohol for ≥12 hours prior to each session and arrive with BrAC = 0.000% at visit 1 and ≤ 0.020% at visit 2. BrAC will be collected immediately after the participant signs the consent form at visit 1.

You may not qualify if:

  • CIWA-Ar ≥10 which suggests clinically meaningful withdrawal.
  • Pregnancy, nursing, or planning pregnancy.
  • Medical contraindications to any alcohol exposure (e.g., liver disease, unstable cardiovascular condition).
  • Current use of medications that strongly affect craving or alcohol consumption (e.g., naltrexone, acamprosate, disulfiram).
  • Severe psychiatric illness or symptoms (e.g., bipolar disorder, schizophrenia, active suicidal ideation) that would interfere with procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (3)

  • Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

    PMID: 2597811BACKGROUND

  • Schacht JP, Ray LA, Miranda R Jr, Falk DE, Ryan ML, Sakai JT, Miotto K, Chun T, Scott C, Ransom J, Alsharif N, Ito M, Litten RZ. Effects of a novel GABA-B positive allosteric modulator, ASP8062, on alcohol cue-elicited craving and naturalistic alcohol consumption in a multisite randomized, double-blind, placebo-controlled trial. Alcohol Clin Exp Res (Hoboken). 2024 Dec;48(12):2352-2363. doi: 10.1111/acer.15468. Epub 2024 Dec 2.

    PMID: 39623527BACKGROUND

  • O'Malley SS, Miranda R Jr, Book SW, Chun TH, Liss T, Malcolm RJ, Muvvala SB, Padovano HT, Schacht JP, Blackburn B, Diamond I, Ransom J, Ryan ML, Falk DE, Litten RZ. Preliminary effects of oral ANS-6637, an ALDH2 inhibitor, on cue-induced craving, safety and alcohol consumption among adults with alcohol use disorder: a proof-of-concept, randomized, human laboratory trial. Alcohol Alcohol. 2025 Jan 19;60(2):agaf001. doi: 10.1093/alcalc/agaf001.

    PMID: 39829301BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Central Study Contacts

Paola R Sparagana, BS

CONTACT

214-645-6950paola.sparagana@utsouthwestern.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 26, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)