Alcohol Use Disorder (AUD)AUD-CUENCT07788716
Sensory and Physical Reactions to Beverage Cues
A study testing Alcohol Cue Reactivity Paradigm in people with Alcohol Use Disorder (AUD), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Alcohol Cue Reactivity Paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Texas Southwestern Medical Center
Dallas, Texas, 75390
E. Sherwood Brown, MD, PhD, 214-645-6950, sherwood.brown@utsouthwestern.edu
About this study
Official title: Sensory and Physiological Responses to Beverage Stimuli: A Randomized Crossover Study
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?
Read more
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).
Read the detailed description
Cue reactivity paradigms are widely used in alcohol use disorder (AUD) research. Utilizing matched alternative beverages offers a unique methodological tool to evaluate these cue-driven responses. This randomized, double-blind, within-subjects crossover study will evaluate craving and beverage liking to distinct beverage stimuli in adults with AUD.
The study will enroll approximately 20 adults aged 21 to 70 years with DSM-5 diagnoses of AUD (mild or greater severity). Following screening and baseline characterization, eligible participants will complete two identical cue reactivity testing sessions spaced approximately 7 days apart. Participants will be randomized (1:1 ratio) to one of two session-order sequences (Sequence AB or Sequence BA). In one session, participants will be exposed to cues corresponding to a target test beverage (prepared to match their typical brand, mixer, and glassware); in the other session, participants will be exposed to a visually and odor-matched similar beverage condition. Participants and study staff will remain fully blinded to condition assignments across both visits.
Each testing visit consists of standardized pre-session clinical evaluations (including breathalyzer testing, vital signs, withdrawal monitoring, and baseline craving questionnaires) followed by a 2-trial cue reactivity protocol conducted in a controlled environment. During each session, participants are exposed to a neutral water cue trial followed by a test-beverage cue trial, using pre-recorded audio instructions that guide participants through holding and smelling each beverage without consumption.
The primary objective is to determine whether exposure to different test-beverage cue conditions produces changes in subjective craving, measured via visual analog scales (VAS). Secondary objectives include evaluating condition differences in beverage liking, peak craving levels, and the trajectory of craving return to baseline post-exposure.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Alcohol Cue Reactivity Paradigm
- Keywords
- AUD, Alcohol Use Disorder, Cue Reactivity
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Cue Reactivity ParadigmBehavioural
Standardized 3-minute visual, olfactory, and tactile exposure to beverage cues (water, and two similar appearing beverages) accompanied by guided audio instructions.
| Study group | Role | What they receive |
|---|---|---|
| Beverage A | Experimental | Exposure to a visually matched beverage to Beverage B Receives: Behavioral: Alcohol Cue Reactivity Paradigm |
| Beverage B | Experimental | Exposure to a visually matched beverage to Beverage A Receives: Behavioral: Alcohol Cue Reactivity Paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Visit 1 (baseline) through Visit 2, an average of 1 week.
Secondary outcomes (1)
Beverage Liking Rating, Visual Analog Scale (VAS)
Beverage liking, peak craving, and return-of-craving-to-baseline, measured using a 20-cm Visual Analog Scale (VAS) ranging from 0 ("Strongly dislike") to 20 ("Strongly like"), with higher scores indicating greater liking. Ratings will be compared between the two different test beverage conditions.
Measured: Visit 1 (baseline) through Visit 2, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788716
- Sponsor's protocol ID
- STU-2026-1429
- Acronym
- AUD-CUE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2597811Schacht 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.
PubMed 39623527O'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.
PubMed 39829301
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory and Physiological Responses to Beverage Stimuli: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07788716
- Acronym / sponsor ID
- AUD-CUE / STU-2026-1429
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- AUD, Alcohol Use Disorder, Cue Reactivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Cue reactivity paradigms are widely used in alcohol use disorder (AUD) research. Utilizing matched alternative beverages offers a unique methodological tool to evaluate these cue-driven responses. This randomized, double-blind, within-subjects crossover study will evaluate craving and beverage liking to distinct beverage stimuli in adults with AUD.
The study will enroll approximately 20 adults aged 21 to 70 years with DSM-5 diagnoses of AUD (mild or greater severity). Following screening and baseline characterization, eligible participants will complete two identical cue reactivity testing sessions spaced approximately 7 days apart. Participants will be randomized (1:1 ratio) to one of two session-order sequences (Sequence AB or Sequence BA). In one session, participants will be exposed to cues corresponding to a target test beverage (prepared to match their typical brand, mixer, and glassware); in the other session, participants will be exposed to a visually and odor-matched similar beverage condition. Participants and study staff will remain fully blinded to condition assignments across both visits.
Each testing visit consists of standardized pre-session clinical evaluations (including breathalyzer testing, vital signs, withdrawal monitoring, and baseline craving questionnaires) followed by a 2-trial cue reactivity protocol conducted in a controlled environment. During each session, participants are exposed to a neutral water cue trial followed by a test-beverage cue trial, using pre-recorded audio instructions that guide participants through holding and smelling each beverage without consumption.
The primary objective is to determine whether exposure to different test-beverage cue conditions produces changes in subjective craving, measured via visual analog scales (VAS). Secondary objectives include evaluating condition differences in beverage liking, peak craving levels, and the trajectory of craving return to baseline post-exposure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beverage A | Experimental | Behavioral: Alcohol Cue Reactivity ParadigmExposure to a visually matched beverage to Beverage B |
| Beverage B | Experimental | Behavioral: Alcohol Cue Reactivity ParadigmExposure to a visually matched beverage to Beverage A |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Cue Reactivity ParadigmStandardized 3-minute visual, olfactory, and tactile exposure to beverage cues (water, and two similar appearing beverages) accompanied by guided audio instructions. | Behavioural | Beverage A, Beverage B |
Primary outcome
Change in Subjective Alcohol Craving Score, Visual Analog Scale (VAS)
Time frame: Visit 1 (baseline) through Visit 2, an average of 1 week.
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.
1 secondary outcome
Beverage Liking Rating, Visual Analog Scale (VAS)
Time frame: Visit 1 (baseline) through Visit 2, an average of 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 2597811Sullivan 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.
- Background: PubMed 39623527Schacht 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.
- Background: PubMed 39829301O'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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Cue Reactivity Paradigm in people with Alcohol Use Disorder (AUD), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola R Sparagana, BS (214-645-6950, paola.sparagana@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Alcohol Craving Score, Visual Analog Scale (VAS) (time frame: Visit 1 (baseline) through Visit 2, an average of 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788716, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.