Computer-Assisted Self-Administration of Ethanol

NCT00713492 | Completed Phase 1 FDA Drug

• 2 other identifiers: 08017808-AA-0178
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Alcoholic Intoxication

Keywords

Alcohol; SELF-ADMINISTRATION; Intoxication

Outcome Measures

Primary Outcomes (1)

• BrAC Exposure (peak BrAC, Average BrAC) during self-administration

  alcohol consumption measured during human lab session.

  2.5 hrs

Secondary Outcomes (1)

• Subjective response during self-administration

  2.5 hrs

Study Arms (1)

1

EXPERIMENTAL

Alcohol

Drug: Alcohol

Interventions

Alcohol DRUG

human laboratory alcohol consumption.

1

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants between 21-45 years of age.
• Good health as determined by normal or non-clinically-significant findings on medical history, physical exam, ECG and lab tests.
• 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.
• 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.

You may not qualify if:

• Current or prior history of serious medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
• Positive hepatitis A, B antigen or C 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-na(SqrRoot) ve individuals or current abstainers) or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime.
• 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).
• 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 propoxyphene, oxycodone 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.
• 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.
• GROUP 6

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Sloan ME, Grant CW, Stangl BL, Klepp TD, Brewton HW, Cinar R, Kunos G, Ramchandani VA. The effects of acute alcohol administration on circulating endocannabinoid levels in humans. Addict Biol. 2022 Sep;27(5):e13197. doi: 10.1111/adb.13197.

  PMID: 36001429 DERIVED

• Vatsalya V, Stangl BL, Ramchandani VA. Assessment of Skin Blood Flow Following Acute Intravenous Alcohol, and Association with Subjective Perceptions, in Social Drinkers. Alcohol Clin Exp Res. 2019 Mar;43(3):405-410. doi: 10.1111/acer.13962. Epub 2019 Feb 8.

  PMID: 30735255 DERIVED

• Gowin JL, Sloan ME, Stangl BL, Vatsalya V, Ramchandani VA. Vulnerability for Alcohol Use Disorder and Rate of Alcohol Consumption. Am J Psychiatry. 2017 Nov 1;174(11):1094-1101. doi: 10.1176/appi.ajp.2017.16101180. Epub 2017 Aug 4.

  PMID: 28774194 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholic Intoxication

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Vijay A Ramchandani, Ph.D.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 11, 2008
• Study Start: October 29, 2008
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: April 24, 2026

Record last verified: 2025-10-23

Locations

US (1)