Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
---|---|
Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00713492 |
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 6-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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Computer-Assisted Self-Administration of Ethanol (CASE) in Humans |
Estimated Enrollment: | 100 |
Study Start Date: | July 2008 |
Objective: The goal of this project is to characterize the computer-assisted self-administration of ethanol (CASE) paradigm by assessing intravenous (IV) alcohol self-administration behavior and the resulting breath alcohol concentration (BrAC) exposure and pharmacologic responses in healthy non-dependent participants. The study will also evaluate the test-retest reliability of alcohol self-administration and examine the influence of sex and recent drinking history on alcohol self-administration.
Study population: Subjects will be 21-45 year-old non-smoking, male and female social drinkers in good health, as determined by medical history, physical exam, ECG and lab tests. Subjects with Axis-I psychiatric illness or alcohol or substance dependence will be excluded.
Design: The CASE system utilizes a model-based algorithm based on previously published methods to achieve and maintain pre-determined BrACs using IV alcohol infusions. The CASE system provides flexibility to participants in choosing when to push a button to receive alcohol, as well as flexibility to investigators in controlling the subsequent BrAC exposure. The CASE system allows the investigator to specify and assure the same BrAC increment across all participants, and is set up to prevent the BrAC from exceeding any pre-set upper limit (e.g., 100 mg%).
Following screening, participants will undergo the IV ethanol self-administration session. Participants will be enrolled in two groups: Group 1 will consist of the first 10 participants who will participate in 3 self-administration sessions (a training session followed by 2 test sessions) to assess the test-retest reliability of alcohol self-administration behavior. Group 2 will consist of 50 participants, who will each participate in 2 self-administration sessions (a training session followed by a test session). During each session, participants will first undergo a directed priming period, lasting 30 min, where they will be prompted to push a button to receive small standardized alcohol infusions. This will be followed by an ad-lib period, lasting up to 2 hrs, where they will have free access to standardized IV alcohol infusions. During the session, BrAC will be measured, heart-rate and skin blood flow will be continuously recorded, and subjective perceptions of alcohol effects and urges will be assessed.
Outcome measures: The primary endpoint is the BrAC exposure (highest BrAC, average BrAC, area-under-the-BrAC-time-curve) achieved during the self-administration session. Additionally, changes in subjective perceptions of alcohol effects, as well as changes in heart rate and skin blood flow will be evaluated. The influence of sex and recent drinking history on the self-administration of alcohol will also be examined.
The CASE paradigm can be a valuable tool for evaluating determinants that may underlie self-administration behavior in humans. The effect of pharmacological agents on alcohol self-administration can be evaluated as a marker of the clinical effectiveness of these agents in the treatment of alcohol-dependence.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080178, 08-AA-0178 |
Study First Received: | July 10, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00713492 |
Health Authority: | United States: Federal Government |
Alcohol Self -Administration Intoxication Healthy Volunteer HV |
Mental Disorders Alcoholic Intoxication Substance-Related Disorders Poisoning |
Disorders of Environmental Origin Alcohol-Related Disorders Healthy Ethanol |