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Computer-Assisted Self-Administration of Ethanol

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 5, 2016 by National Institutes of Health Clinical Center (CC)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: July 10, 2008
Last updated: January 24, 2017
Last verified: December 5, 2016

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.

Condition Intervention
Alcoholic Intoxication
Drug: Alcohol
Procedure: Self-Administration

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Computer-Assisted Self-Administration of Ethanol (CASE) in Humans

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 1) BrAC Exposure (peak, average, AUC). 2) changes in subjective perceptions, heart-rate, skin blood flow.

Secondary Outcome Measures:
  • Effect of sex and drinking history on self-administration.

Estimated Enrollment: 320
Study Start Date: July 7, 2008
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

    1. Male and female participants between 21-60 years of age.
    2. Good health as determined by normal or non-clinically-significant findings on medical history, physical exam, ECG and lab tests.
    3. Female participants 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.
    4. 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 defined as 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.


  1. Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
  2. Positive hepatitis or HIV test at screening.
  3. Current history of of depressive disorder, bipolar disorder, psychotic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), eating disorder, or any other psychiatric disorders (formerly classified as Axis-I) that require intervention.
  4. Current or lifetime diagnosis of alcohol or substance dependence.
  5. Currently seeking treatment for alcohol use disorders.
  6. History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening.
  7. 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.
  8. 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, 4 and 5, participants must be current non-smokers (past smokers who have quit for over 1 year can be included).
  9. Positive result on urine drug screen or positive breathalyzer during screening visit or at the start of any study visit.
  10. Pregnancy or intention to become pregnant for women. Female participants will undergo a urine beta-hCG test to ensure they are not pregnant.
  11. 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.
  12. Current or prior history of alcohol-induced flushing reactions.
  13. Female participants who have abnormal menstrual cycles in the absence of irregularities caused by hormonal contraception, as defined by irregularities in menstrual cycle length (cycles of >36 days or < 8 cycles per year), clinically significant menstrual periods that are heavier or lighter than usual, and/or accompanied by significant pain, cramping or nausea and vomiting that requires intervention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00713492

Contact: Vijay A Ramchandani, Ph.D. (301) 402-8527

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Vijay A Ramchandani, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications: Identifier: NCT00713492     History of Changes
Other Study ID Numbers: 080178  08-AA-0178 
Study First Received: July 10, 2008
Last Updated: January 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Self -Administration
Healthy Volunteer

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on February 20, 2017