Univeristy of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
NCT Number: NCT07788716
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).
Interested in participating?
Request Info21 year–70 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standardized 3-minute visual, olfactory, and tactile exposure to beverage cues (water, and two similar appearing beverages) accompanied by guided audio instructions.
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.
Time frame: Visit 1 (baseline) through Visit 2, an average of 1 week
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.
Contact information is provided by the study sponsor or research team.
University of Texas Southwestern Medical Center
Other
Sensory and Physiological Responses to Beverage Stimuli: A Randomized Crossover Study
Acronym: AUD-CUE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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