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Protocol Details

Nicotinic Receptor Genetic Variation and Alcohol Reward

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-AA-0171

Sponsoring Institute

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

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

Referral Letter Required

No

Population Exclusion(s)

Native Hawaiian/Pacific Islander;
Black or African American;
Asian;
American Indian or Alaskan Native;
Non-English Speaking;
Children

Special Instructions

Currently Not Provided

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Alcohol Drinking

Investigational Drug(s)

IV Ethanol

Investigational Device(s)

None

Intervention(s)

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

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

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:

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.

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Eligibility

INCLUSION CRITERIA:

1) Male and female participants between 21-60 years of age. (assessment: identification provided to Clinical Center Admissions office)

2)Smoking status:

a) Smokers will have a history of at least 1 year of daily smoking, defined as individuals who smoke more than 20 cigarettes/week on average, and a cotinine level, measured by the NicAlert test, of greater than or equal to 4. (assessment: Smoking history questionnaire, Additional medical history, Nic Alert test)

b) Non-smokers with no history of smoking in the past year and less than 20 cigarettes lifetime.(assessment: smoking history questionnaire, Additional medical history)

4) 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)

EXCLUSION CRITERIA:

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. Justification: History of alcohol or substance use disorder will impact brain function and alcohol response. (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-na(SqrRoot) ve 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 performed at screening or update visit under 14-AA-0181 most proximal to enrollment)

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:

a. Use of prescription or OTC medications known to interact with alcohol within 2 weeks of the study. 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.

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

c. 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:

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

b. 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).

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

d. 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.

a. 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.

b. Breast-feeding (assessment: medical history and physical exam).


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



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
vijayr@mail.nih.gov

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: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03294460

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