Actively Recruiting

Phase 1
Age: 21Years - 60Years
All Genders
Healthy Volunteers
NCT03294460

Nicotinic Receptor Genetic Variation and Alcohol Reward

Led by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Updated on 2026-04-15

128

Participants Needed

1

Research Sites

394 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Nicotinic Receptor Genetic Variation and Alcohol Reward

Who Can Participate

Age: 21Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy male and female participants between 21 and 60 years of age
  • Smokers with at least 1 year of daily smoking averaging more than 20 uses of nicotinic products per week and a positive cotinine test
  • Non-smokers with no smoking in the past year and fewer than 20 uses of nicotinic products lifetime
  • Women of childbearing potential must use adequate birth control methods during the study if sexually active and not surgically sterilized
  • Participants must be non-dependent drinkers and in good general health as determined by medical history, physical exam, ECG, and laboratory tests
Not Eligible

You will not qualify if you...

  • Non-English speaking individuals
  • History of major medical illnesses including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders
  • Positive hepatitis A, B, or C antigen or HIV test
  • Current or past 12 months history of psychiatric disorders such as depression, bipolar disorder, or anxiety
  • Lifetime history of psychotic disorders, OCD, PTSD, or eating disorders
  • Current or lifetime diagnosis of alcohol or substance use disorder (except past mild cases in remission for at least 2 years)
  • Currently seeking treatment for alcohol use disorders
  • History or presence of significant alcohol withdrawal symptoms
  • Non-drinkers or individuals who have never consumed 5 or more drinks on one occasion in their lifetime
  • Positive urine drug screen or breathalyzer at screening or repeated visits
  • History of alcohol-induced flushing reactions
  • Use of medications that interact with alcohol or affect hemodynamic responses within specified time frames prior to screening
  • Left-handedness
  • Presence of ferromagnetic objects contraindicated for MRI
  • Fear of enclosed spaces or inability to lie comfortably for up to 2 hours in the MRI scanner
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

V

Vijay A Ramchandani, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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