Nicotinic Receptor Genetic Variation and Alcohol Reward

This study is looking at how a specific gene (CHRNA5, a nicotinic receptor gene) affects how people respond to alcohol. Researchers want to see if variations in this gene change how your brain reacts to alcohol cues and how much alcohol you might choose to drink. You would receive alcohol (oral or intravenous) during the study. The main goals are to measure brain activity using fMRI (functional magnetic resonance imaging) when you see alcohol cues and to track how much alcohol you self-administer. This study is for healthy adults aged 21 to 60, including both smokers and non-smokers. The study's status is currently unclear.

Study design: This is an interventional study planning to enroll 128 participants. It aims to balance groups based on smoking status and a specific gene variation.
What's involved: You would have two 9-hour visits. These visits involve receiving alcohol (oral or IV) and undergoing fMRI scans.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoints are measured at 3 hours after interventions.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Nicotinic Receptor Genetic Variation and Alcohol Reward

Recruiting

PHASE1Ages 21–60InterventionalBasic science

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

~128 participants

Updated 2026-08-28 on ClinicalTrials.gov

What's tested:Alcohol (Oral)Alcohol (IV)Alcohol (Ethanol)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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.

Measured over 3 hours

+1 more outcome measured

Conditions

Alcohol Drinking

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

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

Who to contact

Vijay A Ramchandani, Ph.D.

[email protected]

(301) 402-8527

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.\[assessment: smoking history questionnaire, Additional medical history\]

Exclusion

Use of prescription or OTC medications known to interact with alcohol 2 weeks prior to screening or screening update visit. These include, but may not be limited to: isosorbide; nitroglycerine; benzodiazepines; warfarin; anti-depressants such as amitriptyline, clomipramine and nefazodone; anti-diabetes medications such as glyburide, metformin and tolbutamide; H2-antagonists for heartburn such as famotidine, cimetidine and ranitidine; muscle relaxants; anti-epileptics including phenytoin and phenobarbital; codeine and opioid analgesics including Darvocet, Percocet and hydrocodone;

Regular (more than once a week) or prescribed use of the following medications and unable to refrain from these medications for 48 hours prior to study visits: anti-histamines, pain medicines, and anti-inflammatories such as aspirin, ibuprofen, acetaminophen, celecoxib, and naproxen.

Use of medications known to inhibit or induce enzymes that metabolize alcohol for 4 weeks prior to screening. These include chlorzoxazone, isoniazid, metronidazole, and disulfiram.

Use of drugs known to affect hemodynamic response 2 weeks prior to screening or screening update visit. These include antihypertensives, insulin, and thyroid medications.

Left-handedness \[Edinburgh Handedness Scale\]. Justification: To avoid lateralized effects on brain function measures and reduce potential variance in MRI signals.

Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head \[including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments\].

Fear of enclosed spaces. Justification: To minimize risk and discomfort.

Inability to lie comfortable on back for up to 2 hours in the MRI scanner. Justification: To minimize risk and discomfort. \[assessment: NIAAA MRI Safety Screening Questionnaire\]

Pregnant \[assessment: urine beta-hCG test at screening\]. Women must also test negative on urine beta-hCG test at the start of every study visit.

Breast-feeding \[assessment: medical history and physical exam\].

What this trial measures

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.3 hours
The following measures will be examined as a function of smoking status (smokers and non-smokers) and CHRNA5 genotype. The influence of sex, age, and recent drinking history will be examined as covariates. Primary outcome measures include: (1a) BrAC exposure (peak BrAC, number of infusions, time to binge-level BrAC) during the free-access IV-ASA; (1b) BOLD response during the AFID task in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula. Secondary outcome measures include: (2a) resting state functional connectivity (rsFC) between the regions associated with the salience network, including dorsal anterior cingulate cortex, ventral striatum, and extended amygdala; (2b) preferred rate of self-infusion during the second IV-ASA session.
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.3 hours
The following measures will be examined as a function of smoking status (smokers and non-smokers) and CHRNA5 genotype. The influence of sex, age, and recent drinking history will be examined as covariates. Primary outcome measures include: (1a) BrAC exposure (peak BrAC, number of infusions, time to binge-level BrAC) during the free-access IV-ASA; (1b) BOLD response during the AFID task in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula. Secondary outcome measures include: (2a) resting state functional connectivity (rsFC) between the regions associated with the salience network, including dorsal anterior cingulate cortex, ventral striatum, and extended amygdala; (2b) preferred rate of self-infusion during the second IV-ASA session.

Trialytics