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NCT00713492 · ClinicalTrials.gov registry record · Phase 1
Computer-Assisted Self-Administration of Ethanol
A Phase 1 study of Alcoholic Intoxication, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 1
- Development phase
- 229
- Enrollment target
- 1
- Study location
NCT00713492: Completed Phase 1 study of Alcoholic Intoxication, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT00713492 is a Phase 1 study of Alcoholic Intoxication that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 229 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (282% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00713492, a Phase 1 study of Alcoholic Intoxication, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 229 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
alcohol consumption measured during human lab session.
Conditions Studied
Interventions
- DRUG Alcohol
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2008-10-29 |
| Est. Completion | 2023-12-11 |
| Phase | Phase 1 |
What the finished NCT00713492 record still lists
NCT00713492 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (282% higher).
The record links to 1 condition, with Alcoholic Intoxication appearing as the primary indexed condition, and to 1 intervention - of which Alcohol is the first listed.
NCT00713492 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00713492 about?
NCT00713492 is a clinical study titled "Computer-Assisted Self-Administration of Ethanol". 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...
What is the current status of trial NCT00713492?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 229 participants. The study started on 2008-10-29. Estimated completion is 2023-12-11.
What conditions does trial NCT00713492 study?
This clinical trial studies the following conditions: Alcoholic Intoxication.
What interventions are being tested in trial NCT00713492?
The interventions under investigation include: Alcohol (DRUG).
Who is sponsoring clinical trial NCT00713492?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00713492 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcoholic Intoxication
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00713492's enrollment target sits among peer trials
229 221st of 2000 higher than 1,780 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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