Genetics of the Acute Response to Alcohol in Social Drinkers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01375556
• Date of registration: 16/06/2011
• Prospective Registration: No
• Primary sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Public title: Genetics of the Acute Response to Alcohol in Social Drinkers
• Scientific title: Genetics of the Acute Response to Alcohol in Humans
• Date of first enrolment: May 26, 2011
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01375556
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment.
• Phase: Phase 1

Countries of recruitment

United States

Contacts

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

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Male and female participants between 21-30 years of age.

Good health as determined by medical history, physical exam, EKG and lab tests.

EXCLUSION CRITERIA:

Current or prior history of any disease, including CNS, cardiovascular, respiratory,
gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

Positive hepatitis or HIV test at screening.

Current (i.e., in the past year) diagnosis of Axis-I psychiatric illness.

Current or lifetime diagnosis of alcohol or substance dependence.

Currently (i.e., in the past year) seeking treatment for alcohol-related problems.

Non-drinkers (alcohol-na(SqrRoot) ve individuals or current abstainers), or individuals who
have never consumed more than 4 drinks on at least one occasion.

Current or prior history of alcohol-induced flushing reaction, including rapid reddening of
the face, rapid heart rate and breathing, and nausea after 1 or 2 drinks.

Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal
symptoms. Occasional use of tobacco products (up to 20 cigarettes/week, Fagerstrom Test for
Nicotine Dependence Score less than 4) is acceptable.

Positive result on urine drug screen or breathalyzer test at screening

No regular use of medications for the last 3 months. 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 cimetidine and ranitidine,
muscle relaxants, anti-epileptics including phenytoin and phenobarbital codeine, and
narcotics including darvocet, percocet and hydrocodone. Drugs known to inhibit or induce
enzymes that metabolize alcohol should not be used for 4 weeks prior to the study. These
include chlorzoxazone, isoniazid, metronidazole and disulfiram. Cough-and-cold preparations
which contain anti-histamines, pain medicines and anti-inflammatories such as aspirin,
ibuprofen, acetaminophen, celecoxib and naproxen, should be withheld for at least 72 hours
prior to each study session.

Females must not be pregnant or breast-feeding. Female participants will undergo a urine
beta-hCG test to ensure they are not pregnant during screening and study visits.



Age minimum: 21 Years
Age maximum: 30 Years
Gender: All

Health Condition(s) or Problem(s) studied

Genetics

Alcoholism

Intervention(s)

Drug: Ethanol

Primary Outcome(s)

Initial response to alcohol and adaptive response to alcohol measures for subjective ratings of alcohol effects, psychomotor performance, behavioral disinhibition tasks and autonomic measures

Secondary ID(s)

110180

11-AA-0180

Source(s) of Monetary Support

Please refer to primary and secondary sponsors