Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study ID
- NCT05677321
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Jan 9, 2024
- Status verified
- Oct 2025
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 475 participants (estimated)
Arms
- Arm: Participants with AUDDrink regularly (i.e., 2 or more drinks per day for at least 3 days per week in the past 12 months)
- Arm: Participants without AUDDoes 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
- Chiquita L West(240) 472-6423
- Paule V Joseph, C.R.N.P.(301) 827-5234
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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