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Protocol Details

Nicotinic Receptor Genetic Variation and Alcohol Reward

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21 Years
Max Age: 60 Years

Referral Letter Required


Population Exclusion(s)



Functional Magnetic Resonance Imaging (fMRI);
Alcohol Use;
Polymorphism, Genetic;
Magnetic Resonance Imaging (MRI);

Recruitment Keyword(s)



Alcohol Drinking

Investigational Drug(s)

IV Ethanol

Investigational Device(s)



Drug: Alcohol (Oral)
Drug: Alcohol (IV)
Drug: Alcohol (Ethanol)

Supporting Site

National Institute on Alcohol Abuse and Alcoholism


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.


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.

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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 IUD or other long-acting reversible contraceptive [LARC]; have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner[s]. Justification: To minimize the risk of administering alcohol to pregnant women, given the known effects of alcohol exposure on fetuses. [assessment: medical history]


1. Current or prior history of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders. Justification: Many illnesses may alter the neuropsychological effects of alcohol as well as MRI measures. [assessment: clinically significant findings on medical history and physical exam, ECG, laboratory tests]

2. Positive hepatitis [A, B antigen, or C], or HIV test at screening. Justification: Hepatitis can alter liver function and alcohol pharmacokinetics. HIV infection can alter brain function. [assessment: laboratory tests]

3. Current [past 12 months] history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders. Justification: Concurrent psychopathology can alter brain function and alcohol response. [assessment: SCID interview]

4. Lifetime history of psychotic disorders, obsessive compulsive disorder [OCD], post-traumatic stress disorder [PTSD], or eating disorder. Justification: These disorders can have long-term effects on brain function and alcohol response. [assessment: SCID interview]

5. Current or lifetime diagnosis of alcohol or substance use disorder. Past mild AUD with no current symptoms for atleast 2 years will not be exclusionary. Justification: History of moderate to severe alcohol or substance use disorder will impact brain function and alcohol response. We do not anticipate past mild AUD in remission for 2+ years would have such impact on brain function and alcohol response. We will examine this in our exploratory analysis. [assessment: SCID interview]

6. Currently seeking treatment for alcohol use disorders. Justification: It would be unethical to administer alcohol to individuals seeking treatment for alcohol problems. Also, this study does not provide treatment for individuals with alcohol use disorder. [assessment: medical history]

7. History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms [Clinical Institute Withdrawal Assessment [CIWA] score > 8] at screening. Justification: Withdrawal symptoms would be indicative of alcohol use disorder, which is already an exclusion criteria. Additionally, withdrawal symptoms would be a major safety concern for participants, and a major confound in the assessment of alcohol response and brain function. [assessment: CIWA assessment]

8. Non-drinkers [alcohol-naive individuals or current abstainers] or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime. Justification: It would be unethical to administer alcohol to individuals that do not drink alcohol. [assessment: medical history]

9. Positive result on urine drug screen or positive breathalyzer during screening visit. Positive urine drug screen or breathalyzer reading during more than 1 study visit will result in participant withdrawal from the study. Justification: Current or recent exposure to alcohol or drugs of abuse could impact brain function and alcohol response. [assessment: laboratory tests and breathalyzer test.

10. Current or prior history of alcohol-induced flushing reactions, including rapid reddening of the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks. Justification: It would not be safe to administer alcohol to individuals with the highly aversive flushing response to alcohol. [assessment: alcohol flushing questionnaire]

11. Medication exclusion criteria:

--Regular use of prescription or OTC medications known to interact with alcohol. 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 or prescribed use of 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.

--Regular use of drugs known to affect hemodynamic response. These include antihypertensives, insulin, and thyroid medications.

Note that any discontinuation of medications will only be done at the recommendation of a physician.

[assessment: medical history and physical exam]

12. Exclusion criteria for MRI:

-- 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]

13. Exclusion criteria for women: Justification: To minimize the risk of administering alcohol to pregnant or nursing women, given the known effects of alcohol exposure on fetuses and infants.

-- 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].

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Vijay A. Ramchandani, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 2-2352
10 Center Drive
Bethesda, Maryland 20892
(301) 402-8527

Vijay A. Ramchandani, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health
Building 10
Room 2-2352
10 Center Drive
Bethesda, Maryland 20892
(301) 402-8527

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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