RECRUITING

Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Individual Variations of Taste and Smell Perception in Alcohol Use Disorder (AUD)

Quick Facts

Study Start:2024-01-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05677321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion 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 clinician assessment
  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.
  1. * Diagnosis by a medical professional of morbid obesity or BMI \> 40 or renal disease.
  2. * 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.
  3. * Altered cranial nerves associated with taste and olfaction identified by neurological evaluation during physical exam (screening visit).
  4. * Positive pregnancy test, currently pregnant or breastfeeding.
  5. * Hypoglycemic drug intake.
  6. * Currently using medications known to inhibit taste response (GLP1 agonists).
  7. * Currently experiencing temporary change/loss of taste and/or smell (individual may be rescreened when symptoms resolve).
  8. * Persistent loss of taste and/or smell due to COVID-19 or other reason.
  9. * NIAAA employees/staff or subordinates/relatives/co-workers of NIAAA employees/staff or study investigators.
  10. * claustrophobia
  11. * Ferromagnetic metal in the cranial cavity or eye, e.g., aneurysm clip implanted neural stimulator, cochlear implant, ocular foreign body.
  12. * Presence of implanted cardiac pacemaker or auto-defibrillator.
  13. * Individuals with an insulin pump.
  14. * Presence of an irremovable body piercing.
  15. * 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.

Contacts and Locations

Study Contact

Chiquita L West
CONTACT
(240) 472-6423
chiquita.west@nih.gov
Paule V Joseph, C.R.N.P.
CONTACT
(301) 827-5234
paule.joseph@nih.gov

Principal Investigator

Paule V Joseph, C.R.N.P.
PRINCIPAL_INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  • Paule V Joseph, C.R.N.P., PRINCIPAL_INVESTIGATOR, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-01-09
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • chemosensation
  • Preference
  • Natural History

Additional Relevant MeSH Terms

  • Alcohol Use Disorder