Nicotinic Receptor Genetic Variation and Alcohol Reward

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.

Conditions

• Alcohol Drinking

Interventions

DRUG

Alcohol (Oral)

Oral Self-administration

DRUG

Alcohol (IV)

IV Self-administration

DRUG

Alcohol (Ethanol)

IV and Oral Self-administration

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  lead NIH

Principal Investigators

• Vijay A Ramchandani, Ph.D. · National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-10

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations