Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05677321 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
MinorEligibility criteria expanded, about 20 words
MinorRe-verified, no change to tracked fieldsv237
MinorStudy Status, Eligibilityv236
Show 45 earlier versionsHide 45 earlier versions
Minor9 versionsRe-verified since Aug 23, 2024, no change to tracked fieldsv227-v235
MinorStudy Status, Study Descriptionv226
Minor3 versionsRe-verified since Feb 29, 2024, no change to tracked fieldsv223-v225
MinorEligibility criteria shortened, about 26 wordsv222
MinorStart date changed from estimate of Jan 16, 2024 to Jan 9, 2024v221
MinorStart date: Jan 12, 2024 to Jan 16, 2024v220
MinorStart date: Jan 11, 2024 to Jan 12, 2024v219
MinorStart date: Jan 10, 2024 to Jan 11, 2024v218
MinorStart date: Jan 9, 2024 to Jan 10, 2024v217
MinorStart date: Jan 8, 2024 to Jan 9, 2024v216
MinorStart date: Jan 4, 2024 to Jan 8, 2024v215
MinorStart date: Jan 3, 2024 to Jan 4, 2024v214
MinorStart date: Jan 2, 2024 to Jan 3, 2024v213
MinorStart date: Jan 1, 2024 to Jan 2, 2024v212
MinorStart date: Dec 27, 2023 to Jan 1, 2024v211
MinorStart date: Dec 26, 2023 to Dec 27, 2023v210
MinorStart date: Dec 25, 2023 to Dec 26, 2023v209
MinorStart date: Dec 24, 2023 to Dec 25, 2023v208
MinorStart date: Dec 21, 2023 to Dec 24, 2023v207
MinorStart date: Dec 20, 2023 to Dec 21, 2023v206
MinorStart date: Dec 19, 2023 to Dec 20, 2023v205
MinorStart date: Dec 18, 2023 to Dec 19, 2023v204
MinorStart date: Dec 17, 2023 to Dec 18, 2023v203
MinorStart date: Dec 14, 2023 to Dec 17, 2023v202
MinorStart date: Dec 13, 2023 to Dec 14, 2023v201
MinorStart date: Dec 10, 2023 to Dec 13, 2023v200
MinorStart date: Dec 7, 2023 to Dec 10, 2023v199
MinorStart date: Dec 5, 2023 to Dec 7, 2023v198
MinorStart date: Dec 4, 2023 to Dec 5, 2023v197
MinorStart date: Dec 3, 2023 to Dec 4, 2023v196
MinorStart date: Nov 30, 2023 to Dec 3, 2023v195
MinorStart date: Nov 28, 2023 to Nov 30, 2023v194
MinorStart date: Nov 27, 2023 to Nov 28, 2023v193
MinorStart date: Nov 26, 2023 to Nov 27, 2023v192
MinorStart date: Nov 23, 2023 to Nov 26, 2023v191
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.