Recruiting

Observational Study

Sponsor:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Code:

NCT05677321

Conditions

Alcohol Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

Alcohol use disorder (AUD) is the most common substance use disorder in the world. Long-term AUD can affect a person s sense of taste and smell. This natural history study will compare alcohol drinking behaviors and measures of taste and smell in people with and without AUD.

Objective:

To understand how alcohol use changes the senses of taste and smell.

Eligibility:

People aged 18 to 65 years with or without AUD.

Design:

Participants will be screened. They will have several tests to assess their smell and taste functions. They will answer questions about their eating, alcohol use, and smoking or vaping habits.

Participants will have 2 study visits.

They will give samples of blood, nasal mucous, saliva, stool, and urine.

Their bodies will be measured. They will undergo a type of scan that uses X-rays to measure their body composition.

They will complete taste measurements. They will taste liquids by swishing them in their mouth, without swallowing. Then, they will be asked what they can detect and which flavors they preferred.

They will also complete smell measurements. They will be asked if they can identify strong odors on a metal wand. They will be asked to rate the intensity and pleasantness of odors.

Their brain activity in the frontal regions will be measured while they smell various odors. For this, we will use a brain imaging tool called functional near infrared spectroscopy.

They will have sensory testing. Sensations such as pressure, pinpricks, heat, or vibrations will be applied to their skin. Then, they will be asked what they felt.

They will keep diaries. They will write down what they eat (for 3 days), the alcohol they drink (3 days), and how much they sleep (14 days). They will wear a wristwatch-like device that records their activity for 14 days.

Conditions

Alcohol Use Disorder

Study ID

NCT05677321

Start date

Jan 9, 2024

Status verified date

Jun 11, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

  • Individuals between 18 to 65 years of age. Although the age range of participants recruited in the NIAAA Natural History protocol is between 18-77 years, due to documented knowledge that taste and smell diminishes with age, we will limit age to this range.
  • Individuals with a diagnosis of AUD (for the AUD cohort) OR without a diagnosis of AUD (for the non-AUD cohort) per clinician assessment
  • Able to provide their own consent.
  • Due to the extensive questionnaires (administered in English language only) that participants must complete independently, fluency in the English language is needed. Hence, participants must be able to read and understand English.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Diagnosis by a medical professional of morbid obesity or BMI > 40 or renal disease.
  • Any history of chronic rhinitis, eating disorder, chronic upper respiratory infection, chronic allergic rhinitis, or nasal polyps in the last 6 months of screening, or current daily use of nasal sprays.
  • Altered cranial nerves associated with taste and olfaction identified by neurological evaluation during physical exam (screening visit).
  • Positive pregnancy test, currently pregnant or breastfeeding.
  • Hypoglycemic drug intake.
  • Currently using medications known to inhibit taste response (GLP1 agonists).
  • Currently experiencing temporary change/loss of taste and/or smell (individual may be rescreened when symptoms resolve).
  • Persistent loss of taste and/or smell due to COVID-19 or other reason.
  • NIAAA employees/staff or subordinates/relatives/co-workers of NIAAA employees/staff or study investigators.

fMRI Exclusion Criteria

  • Claustrophobia
  • Ferromagnetic metal in the cranial cavity or eye, e.g., aneurysm clip implanted neural stimulator, cochlear implant, ocular foreign body.
  • Presence of implanted cardiac pacemaker or auto-defibrillator.
  • Individuals with an insulin pump.
  • Presence of an irremovable body piercing.
  • Individuals who are pregnant or breastfeeding during screening, or who become pregnant during the study, will be excluded from participation due to risk of exposing the fetus to undue magnetic field hazards associated with MRI.

Study Design

Enrollment

475 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with AUD

Drink regularly (i.e., 2 or more drinks per day for at least 3 days per week in the past 12 months)

Participants without AUD

Does not drink regularly (less than 2 drinks per day for at least 3 days per week in the past 12 months)

Primary outcome measure

  • Taste and smell measures, alcohol drinking behavior [ Time Frame: At enrollment ]

Central Contacts and Locations

Central contacts

Chiquita L West

(240) 472-6423chiquita.west@nih.gov

Paule V Joseph, C.R.N.P.

(301) 827-5234paule.joseph@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Last update posted

Jun 16, 2026

Last verified

Jun 11, 2026

Keywords

  • chemosensation
  • Preference
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA) on 2026-06-16.