This study is NOT currently recruiting participants.
Number
000421-AA
Sponsoring Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 65 Years
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
chemosensation; Preference; Natural History
Recruitment Keyword(s)
None
Condition(s)
Alcohol Use Disorder
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute on Alcohol Abuse and Alcoholism
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.
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INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: 1. 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. 2. Individuals with a diagnosis of AUD (for the AUD cohort) OR without a diagnosis of AUD (for the non-AUD cohort) per SCID assessment at screening. 3. Able to provide their own consent. 4. 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: -Because type-2 diabetic individuals have blunted taste responses, those with diagnosis of type-2 diabetes will be excluded. - Diagnosis by a medical professional of morbid obesity or BMI > 40, liver, or renal disease. Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric). - Any history of chronic rhinitis, eating disorder (including binge eating), 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). - Hemoglobin A1C level > 6.5%. - Abnormal complete blood count (CBC): White Blood Cell Count < 4 or > 10 K/uL, Red Blood Cell Count < 4 or > 7 M/uL, Hemoglobin < 12 g/dL for females or < 13 g/dL for males, or any clinical signs/symptoms that indicate iron-deficiency anemia per clinician s judgment at screening. - Positive pregnancy test, currently pregnant or breastfeeding. - Hypoglycemic drug intake. -Current use of a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications. - Currently using any of the following medications: steroidal or non-steroidal anti-inflammatory medications, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, or antibiotics. - Regular use of illicit drugs (e.g., marijuana, cocaine) in the last 30 days - Diagnosis of substance use disorder in the last 12 months. - 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.
To be eligible to participate in this study, an individual must meet all the following criteria:
1. 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.
2. Individuals with a diagnosis of AUD (for the AUD cohort) OR without a diagnosis of AUD (for the non-AUD cohort) per SCID assessment at screening.
3. Able to provide their own consent.
4. 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:
-Because type-2 diabetic individuals have blunted taste responses, those with diagnosis of type-2 diabetes will be excluded.
- Diagnosis by a medical professional of morbid obesity or BMI > 40, liver, or renal disease. Currently have an uncontrolled medical disorder (i.e., gastrointestinal, endocrine, cardiac, psychiatric).
- Any history of chronic rhinitis, eating disorder (including binge eating), 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).
- Hemoglobin A1C level > 6.5%.
- Abnormal complete blood count (CBC): White Blood Cell Count < 4 or > 10 K/uL, Red Blood Cell Count < 4 or > 7 M/uL, Hemoglobin < 12 g/dL for females or < 13 g/dL for males, or any clinical signs/symptoms that indicate iron-deficiency anemia per
clinician s judgment at screening.
- Positive pregnancy test, currently pregnant or breastfeeding.
- Hypoglycemic drug intake.
-Current use of a medication known to affect taste perception: Antibiotics, thyroid medications, psychotropic, neurological, and cardiac medications.
- Currently using any of the following medications: steroidal or non-steroidal anti-inflammatory medications, medications known to inhibit taste response (GLP1 agonists), antiepileptic or antidepressant agents, glucocorticoids, or antibiotics.
- Regular use of illicit drugs (e.g., marijuana, cocaine) in the last 30 days
- Diagnosis of substance use disorder in the last 12 months.
- 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.
Principal Investigator
Referral Contact
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