Computer-Assisted Self-Administration of Ethanol

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00713492
First received: July 10, 2008
Last updated: July 2, 2014
Last verified: December 2013
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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: 250
Study Start Date: July 2008
Estimated Study Completion Date: June 2015
Intervention Details:
    Drug: Alcohol
    N/A
    Procedure: Self-Administration
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  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 ClinicalTrials.gov identifier: NCT00713492

Contacts
Contact: Vijay A Ramchandani, Ph.D. (301) 402-8527 vijayr@mail.nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Vijay A Ramchandani, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00713492     History of Changes
Other Study ID Numbers: 080178, 08-AA-0178
Study First Received: July 10, 2008
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 29, 2014