Nicotinic Receptor Genetic Variation and Alcohol Reward
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|ClinicalTrials.gov Identifier: NCT03294460|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : November 8, 2019
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.
To see if people with variations of a nicotine receptor gene take alcohol differently and have different brain responses to alcohol cues.
Healthy adults ages 21 - 60. This study includes smokers and non-smokers.
Participants will be screened under another protocol.
Participants will have three 9-hour visits. They must have no alcohol or non-prescription drugs before all visits and no food or drink before 2 visits.
At every visit, participants will:
- Get a light meal
- Have breath and urine tests
- Get taxi rides there and back
At visits 1 and 3, 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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking||Drug: Alcohol (Oral) Drug: Alcohol (IV) Drug: Alcohol (Ethanol)||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Nicotinic Receptor Genetic Variation and Alcohol Reward|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Alcohol self-administration (IV ethanol for sessions 1 and 3, oral for session 2)
Drug: Alcohol (Oral)
Drug: Alcohol (IV)
Drug: Alcohol (Ethanol)
IV and Oral Self-administration
- To examine the effect of CHRNA5 (rs16969968) genetic variation on neural correlates of incentive salience for alcohol, as measured by BOLD response during the Alcohol-Food Incentive Delay (AFID) task using fMRI. [ Time Frame: Study Completion ]
- To examine the effect of CHRNA5 (rs16969968) genetic variation on IV alcohol self-administration, as measured by BrAC exposure (peak BrAC, number of infusions, time to binge-level) in non-smoking, non-dependent drinkers. [ Time Frame: Study Completion ]
- To examine the effect of CHRNA5 (rs16969968) genetic variation on resting-state functional connectivity (rsFC) among brain regions [ Time Frame: Study Completion ]associated with the salience network, including dorsal anterior cingulate cortex, ventral striatum and extended amygdala in non-smoking non-dependent drinkers.
- To examine the effect of CHRNA5 (rs16969968) genetic variation on the rate of IV alcohol self-administration, as measured by the preferred rate during the second IV-ASA session in non-smoking, non-dependent drinkers. [ Time Frame: Study Completion ]
- To examine the relationship between fMRI measures (BOLD response during AFID and rsFC measures) and IV alcohol self-administration, and any differences in the degree of association among these measures by CHRNA5 genotype. [ Time Frame: Study Completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294460
|Contact: Vijay A Ramchandani, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Vijay A Ramchandani, Ph.D.||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|