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Recruiting Phase 1 NCT03294460

Nicotinic Receptor Genetic Variation and Alcohol Reward

Trial Parameters

Condition Alcohol Drinking
Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 128
Sex ALL
Min Age 21 Years
Max Age 60 Years
Start Date 2019-06-10
Completion 2026-12-31
Interventions
Alcohol (Oral)Alcohol (IV)Alcohol (Ethanol)

Brief Summary

Background: People with the brain disease AUD (alcohol use disorder) have a serious problem with drinking. Researchers want to study how different people react to alcohol, and how genes affect this. They will focus on a nicotine receptor gene that may increase a person s AUD risk. Objectives: To see if people with variations of a nicotine receptor gene take alcohol differently and have different brain responses to alcohol cues. Eligibility: Healthy adults ages 21 - 60. This study includes smokers and non-smokers. Design: Participation will be based on evaluation under the NIAAA natural history protocol (14-AA-0181) or a screening visit under this protocol. Participants will have two 9-hour visits. They must have no alcohol or non-prescription drugs before all visits and no food or drink before the first visit. At every visit, participants will: * Get a light meal * Have breath and urine tests * Get taxi rides there and back At visits 1, participants will: * Have a thin plastic tube inserted in an arm and connected to a pump for alcohol infusion. * Have sensors on their chest to monitor heart rate. * Sit in a chair for 2.5 hours and get alcohol by pushing a button. Their breath alcohol level will be monitored. * Answer questions about mood and effects of alcohol * Give blood samples * Relax at the clinic while their breath alcohol level drops At visit 2, participants will: * Answer questions and do computer tests * Have an alcoholic drink and a snack * Have a magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of the brain. They will do computer tasks. * Have another drink and snack * Relax until their alcohol level drops Participants will have a follow-up call after each visit.

Eligibility Criteria

* INCLUSION CRITERIA: 1. Male and female participants between 21-60 years of age. \[assessment: identification provided to Clinical Center Admissions office\] 2. Smoking status: * Smokers will have a history of at least 1 year of daily smoking, defined as individuals who smoke more than 20 uses of nicotinic products/week on average, and a cotinine level, measured by the NarcoCheck PreDosage Nicotine Test \[PNT\] test, of \>= 2. \[assessment: Smoking history questionnaire, Additional medical history, PreDosage Nicotine test\] * Non-smokers with no history of smoking in the past year and less than 20 uses of nicotinic products lifetime.\[assessment: smoking history questionnaire, Additional medical history\] 3. Inclusion criteria for women: Use of adequate method of birth control during the study, if female is sexually active and is not surgically sterilized. Adequate methods of contraception include: use of oral contraceptives; use of barrier method of contraceptive; use of an approved

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