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Protocol Details

Computer-Assisted Self-Administration of Ethanol (CASE) in Humans

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

08-AA-0178

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: 45

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Alcohol;
Self -Administration;
Intoxication

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Alcoholic Intoxication

Investigational Drug(s)

IV Ethanol Solution

Investigational Device(s)

None

Intervention(s)

Drug: Alcohol
Procedure/Surgery: Self-Administration

Supporting Site

National Institute on Alcohol Abuse and Alcoholism

This study will test the reliability of a procedure for self-administering ethanol (alcohol) intravenously (through a vein), using a computer-assisted method. People ordinarily self-administer alcohol through drinking alcoholic beverages, but blood alcohol levels resulting from drinking vary greatly among individuals. For research on alcohol dependence and treatment, a tool for achieving precise blood levels is needed. In addition to testing this method of alcohol administration, the study will examine self-administration behavior and resulting breath alcohol concentration, the effects of alcohol on the participants, and differences between men and women in alcohol self-administration.

Healthy normal volunteers between 21 and 45 years of age may be eligible for this study. Participants are assigned to one of two study groups. Group 1 undergoes three 7-hour study sessions and group 2 participates in two sessions, each of which includes the following procedures:

Breathalyzer and urine tests for alcohol and illicit drug use.

Urine pregnancy test for women.

Light lunch.

Questionnaire about health and recent drinking.

Alcohol infusion: Subjects are seated in a comfortable chair and instructed on how to use a computer to give themselves a short infusion of alcohol through a catheter (plastic tube) that has been inserted into a vein in their the arm. Sensors are placed on their chest to monitor heart beat and their neck to record skin blood flow. At the start of the session, subjects complete questionnaires about any drug effects and urges to drink they may be feeling. They are trained on how to use the computer to administer alcohol and are then allowed to self-administer alcohol through the catheter any time they like, as long as their peak breath alcohol level does not exceed 0.1 g% (a level that would result from ingestion of 4 to 6 drinks in most people). If that point is reached, the computer automatically inactivates self-administration until the level is lowered again. Breathalyzer readings are taken every 15 to 30 minutes. Subjects may read, watch television or videos or listen to music during the sessions.

Recovery: At the end of the 2.5 hours of self-administration, the catheter is removed and subjects can eat, read, watch television and relax in the clinic until their breath alcohol level falls below 0.02 g%, usually after 2.5 to 3 hours, when they can go home by taxi or with a pre-arranged designated driver.

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Eligibility

INCLUSION CRITERIA:

-Male and female participants between 21-45 years of age.

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

-Female participants will have normal menstrual cycles and will be tested during the follicular phase of their cycle (within 10 days of offset of menses) and must have a negative urine pregnancy (hCG) test at the start of each study session. For group 5, due to the number of study visits, female subjects will be tested outside the menses phase of their cycle.

-Group 5 will include 20 subjects who report at least 2 binge drinking episodes in the month prior to the study (a binge episode is definedas consuming at least 4 drinks for females and at least 5 drinks for males during the drinking episode) and 20 subjects who report no binge drinking episodes in the past month.

EXCLUSION CRITERIA:

-Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.

-Positive hepatitis or HIV test at screening.

-Current history of Axis-I psychiatric illness.

-Current or lifetime diagnosis of alcohol or substance dependence.

-Currently seeking treatment for alcohol use disorders.

-History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.

-Non-drinkers (alcohol-naive individuals or current abstainers) or no experience drinking 5 or more drinks on one occasion.

-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) is acceptable. For groups 3 and 4, participants must be current non-smokers (past smokers who have quit for over 1 year can be included).

-Positive result on urine drug screen or positive breathalyzer during screening visit or at the start of any study visit.

-Pregnancy or intention to become pregnant for women. Female participants will undergo a urine beta-hCG test to ensure they are not pregnant.

-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.

-Current or prior history of alcohol-induced flushing reactions.


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Citations:

Anton RF, Drobes DJ, Voronin K, Durazo-Avizu R, Moak D. Naltrexone effects on alcohol consumption in a clinical laboratory paradigm: temporal effects of drinking. Psychopharmacology (Berl). 2004 Apr;173(1-2):32-40. Epub 2004 Jan 14.

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.

Davidson D, Palfai T, Bird C, Swift R. Effects of naltrexone on alcohol self-administration in heavy drinkers. Alcohol Clin Exp Res. 1999 Feb;23(2):195-203.

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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)
National Institutes of Health
Building 10
Room 2-2352
10 Center Drive
Bethesda, Maryland 20892
(301) 402-8527
vijayr@mail.nih.gov

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

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00713492

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