Eligibility Details:
- INCLUSION CRITERIA:
- Male and female participants between 21-60 years of age. (assessment: identification
provided to Clinical Center Admissions office)
- Smoking status:
1. 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)
2. Non-smokers with no history of smoking in the past year and less than 20
cigarettes lifetime.(assessment: smoking history questionnaire, Additional
medical history)
- 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:
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Medication exclusion criteria:
1. 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.
2. 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.
3. 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)
- Exclusion criteria for MRI:
1. Left-handedness (Edinburgh Handedness Scale). Justification: To avoid lateralized
effects on brain function measures and reduce potential variance in MRI signals.
2. 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).
3. Fear of enclosed spaces. Justification: To minimize risk and discomfort.
4. 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)
- 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.
1. 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.
2. Breast-feeding (assessment: medical history and physical exam).
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
