Genetics of the Acute Response to Alcohol in Social Drinkers

NCT01375556 | Terminated Phase 1

• 2 other identifiers: 11018011-AA-0180
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Previous research has shown that a person s genes can influence how they respond to alcohol. But researchers do not yet know all the genes that might be involved. Objectives: \- To identify genes that are related to how non-alcoholic individuals respond to alcohol. Eligibility: \- Healthy people between 21 and 30 years of age who have no history of alcohol or drug dependence. Design:

• The study requires one or two 9-hour visits to the National Institutes of Health Clinical Center.
• Participants must not take any medicines (except birth-control pills for women) for at least 3 days before the visit. They must not drink alcohol for at least 2 days before the visit.
• Screening includes a medical history, physical exam, and a urine test for drugs of abuse.
• Participants will be given alcohol over about 2.5 hours. This will have about the same effect as having three to four drinks. Frequent breathalyzer tests will check breath alcohol level during the infusion.
• Before and during the infusion, participants will complete questionnaires about mood and feelings. Other tests will study thinking, balance, judgment, and risk-taking. Blood samples will be collected four times during the infusion.
• Participants will have breakfast at the start of the visit (around 8:00 AM). They will have a snack before the start of the alcohol infusion (around 10:45 AM). Lunch will be served after the alcohol infusion is complete (around 2:20 PM). After the tests, those in the study will have to stay in the Clinical Center until their breath alcohol level falls below 0.02%. This can take up to 2.5 hours. A final blood sample will be drawn at that time. Participants will not be able to drive themselves home after the study visits. Also, they should not take any medicines or operate any machinery for at least 2 hours after leaving NIH.

Conditions

Alcoholism; Genetics

Keywords

Alcohol Clamp; Pharmacogenetics; Family History of Alcoholism; Pharmacodynamics; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

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

Interventions

Ethanol DRUG

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants between 21-30 years of age.
• Good health as determined by medical history, physical exam, EKG and lab tests.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

  PMID: 12615092 BACKGROUND

• Bierut LJ, Agrawal A, Bucholz KK, Doheny KF, Laurie C, Pugh E, Fisher S, Fox L, Howells W, Bertelsen S, Hinrichs AL, Almasy L, Breslau N, Culverhouse RC, Dick DM, Edenberg HJ, Foroud T, Grucza RA, Hatsukami D, Hesselbrock V, Johnson EO, Kramer J, Krueger RF, Kuperman S, Lynskey M, Mann K, Neuman RJ, Nothen MM, Nurnberger JI Jr, Porjesz B, Ridinger M, Saccone NL, Saccone SF, Schuckit MA, Tischfield JA, Wang JC, Rietschel M, Goate AM, Rice JP; Gene, Environment Association Studies Consortium. A genome-wide association study of alcohol dependence. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5082-7. doi: 10.1073/pnas.0911109107. Epub 2010 Mar 2.

  PMID: 20202923 BACKGROUND

• Blekher T, Ramchandani VA, Flury L, Foroud T, Kareken D, Yee RD, Li TK, O'Connor S. Saccadic eye movements are associated with a family history of alcoholism at baseline and after exposure to alcohol. Alcohol Clin Exp Res. 2002 Oct;26(10):1568-73. doi: 10.1097/01.ALC.0000033121.05006.EF.

  PMID: 12394291 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Vijay A Ramchandani, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 17, 2011
• Study Start: May 26, 2011
• Primary Completion: January 20, 2016
• Study Completion: January 20, 2016
• Last Updated: November 29, 2019

Record last verified: 2016-01-20

Locations

US (1)