Computer-Assisted Self-Administration of Ethanol - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00713492

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 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

Drug Information available for: Ethanol

U.S. FDA Resources

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

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

Primary Outcome Measures:

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:	100
Study Start Date:	July 2008

Intervention Details:

N/A

Detailed Description:

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.

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, EKG 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.

EXCLUSION CRITERIA:

Current or prior history of any disease, 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 or abuse.
Non-drinkers (alcohol-naive individuals or current abstainers).
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.
Positive result on urine drug screen.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713492

Contacts

Contact: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site

Publications:

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.

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

Keywords provided by National Institutes of Health Clinical Center (CC):

Alcohol
Self -Administration
Intoxication
Healthy Volunteer
HV

Study placed in the following topic categories:

Mental Disorders
Alcoholic Intoxication
Substance-Related Disorders
Poisoning

Disorders of Environmental Origin
Alcohol-Related Disorders
Healthy
Ethanol

ClinicalTrials.gov processed this record on January 14, 2009