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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)