The Impact of Oral Ethanol and Vaped Ethanol on the Evaluation of Impairment

December 19, 2025 updated by: Virginia Commonwealth University
The purpose of this research study is to determine if ethanol-containing e-cigarettes impact ethanol breath, blood or oral fluid tests, field sobriety tests, or other tests of sobriety. Ethanol is a common part of e-cigarette liquids.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alison Breland, PhD
  • Phone Number: 8048273562
  • Email: ctsp@vcu.edu

Study Contact Backup

  • Name: Nicoleta Gaitan, RN
  • Phone Number: 8048273562
  • Email: gaitann@vcu.edu

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • e-cigarette users
  • alcohol consumers
  • willing to provide informed consent
  • able to attend the lab sessions as needed
  • agree to use designated products according to study protocol.

Exclusion Criteria:

- Women who are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Within group four condition comparison
Participants completed four ~5-hour, Latin-square ordered sessions separated by ≥48 hours. Session order was not recorded as it was not relevant to the study outcomes: Beverage with ethanol and E-cigarette liquid with ethanol, Beverage with ethanol and E-cigarette liquid without ethanol, Beverage without ethanol and E-cigarette liquid with ethanol, and Beverage without ethanol and E-cigarette liquid without ethanol.
Other: Beverage with ethanol and E-cigarette liquid with ethanol
Beverage with ethanol and E-cigarette liquid with ethanol
Other: Beverage with ethanol and E-cigarette liquid without ethanol
Beverage with ethanol and E-cigarette liquid without ethanol
Other: Beverage without ethanol and E-cigarette liquid with ethanol
Beverage without ethanol and E-cigarette liquid with ethanol
Other: Beverage without ethanol and E-cigarette liquid without ethanol
Beverage without ethanol and E-cigarette liquid without ethanol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Alcohol Concentration
Time Frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Blood alcohol concentration (BAC) level was determined 6 times over 6 hours to assess for changes in BAC from use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Blood collected before (baseline) and after (0, 40, 55, 200, 215) drinking. The e-cigarette was used at 50 and 210 minutes post-drinking.
Breath Alcohol Concentration
Time Frame: Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Breath Alcohol Concentration (BrAC) was assessed 12 times over 6 hours to determine changes in BrAC from the use of an e-cigarette containing ethanol compared to the use of an e-cigarette without ethanol.
Breath was analyzed before (baseline) and after (10, 20, 40, 55, 90, 120, 165, 200, 215, 240, 270 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Oral Fluid Alcohol Concentration (OFAC)
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Oral fluid alcohol concentration (OFAC) was assessed 9 times over 6 hours to determine changes in OFAC from the use of an e-cigarette containing ethanol compared to use of an e-cigarette without ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarker (5-Hydroxytryptophol) in Blood
Time Frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) in Blood
Time Frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Blood/ E-cig Containing Ethanol
Time Frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethyl sulfate was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) in Blood
Time Frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Blood
Time Frame: Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood was collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxytryptophol Glucuronide) Analyzed in Blood
Time Frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxytryptophol glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (5-Hydroxytryptophol) in Blood
Time Frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethanol Biomarkers (5-Hydroxytryptophol) in Analyzed in Oral Fluid
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking
Ethanol Biomarkers (5-Hydroxyindoleacetic Acid) Analyzed in Oral Fluid
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
5-Hydroxyindoleacetic acid was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Sulfate) Analyzed in Oral Fluid
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl sulfate was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:1) Analyzed in Blood
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:1 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Phosphatidylethanol 16:0-18:2) in Oral Fluid
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Phosphatidylethanol 16:0-18:2 was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participants at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Blood
Time Frame: Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking.
Ethyl glucuronide was analyzed in blood 6 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Blood collected before (baseline) and after (0, 40, 55, 200, 215 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking.
Ethanol Biomarkers (Ethyl Glucuronide) Analyzed in Oral Fluid
Time Frame: Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking
Ethyl glucuronide was analyzed in oral fluid 9 times over a course of 6 hours to assess changes in determined concentrations from use of an electronic cigarette containing ethanol.
Oral fluid was collected before (baseline) and after (0, 5, 20, 40, 55, 200, 215, 240 min) drinking. The e-cigarette was used by the participant at 50 and 210 minutes post-drinking

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Horizontal Gaze Nystagmus
Time Frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).

Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the Horizontal Gaze Nystagmus (a jerking or stuttering type of movement observed in a person's eyes that occurs as a result of consuming alcohol or other nervous system depressants) test. For each test, a law enforcement officer records the number of clues observed. HGN has a maximum of 6 clues, 3 per eye:

  1. lack of smooth pursuit
  2. distinct and sustained nystagmus at maximum deviation
  3. onset of nystagmus prior to 45 degrees.
Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
Walk and Turn Test
Time Frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).

Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the walk and turn test (suspect to perform a physical task while simultaneously following instructions and maintaining balance; involves walking a straight line heel-to-toe, turning, and walking back, with officers looking for specific indicators of impairment). For each test, a law enforcement officer records the number of clues observed. WAT has a maximum of 8 clues:

  1. inability to balance during the instruction phase
  2. starting before the officer has finished the instructions
  3. Stopping while walking to regain balance
  4. Not touching heel-to-toe
  5. Stepping off the line
  6. Using arms to balance
  7. Losing balance on the turn or turning incorrectly
  8. Taking the wrong number of steps
Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
One Leg Stand Test
Time Frame: Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).
Standard Field Sobriety Tests (SFSTs) were administered 4 times over a course of 6 hours to assess changes in objective impairment. The SFST includes the one-leg stand test (assess balance and coordination, potentially indicating impairment due to alcohol or drugs). For each test, a law enforcement officer records the number of clues observed. OLS has a maximum of 4 clues: Swaying while balancing, Using arms for balance, Hopping 4. Putting the raised foot down
Conducted before drinking (baseline), at 20 minutes post-drinking (before first vaping bout), at 55 minutes post-drinking (after the first vaping), and at 215 minutes post-drinking (after second vaping bout).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subjective High Assessment Scale Questionnaire (SHAS)
Time Frame: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Subjective High Assessment Scale Questionnaire (SHAS) is a 14-item questionnaire used to assess how intoxicated a person feels after consuming alcohol, typically administered in laboratory settings. It focuses on capturing subjective sensations associated with intoxication, such as feeling "clumsy," "dizzy," or "high". Participants rate their experience on a visual analog scale (a line with markings) to indicate the extent to which they feel each symptom at a given time. The scale ranges from Normal" (0) to "Extremely" (100). The score for each of the questions is summed to give an overall indication of the individual's subjective intoxication. A higher score would indicate greater feelings of impairment.
Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Biphasic Alcohol Effects Scale Questionnaire (BAES)
Time Frame: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Biphasic Alcohol Effects Scale Questionnaire (BAES) is a 14-item questionnaire consisting of adjectives that describe the stimulant- and sedative-like effects of alcohol. The items are presented in alphabetical order, and are rated on an 11-point rating scale from 0=Not at All to 10=Extremely. The score for each of the questions was summed to give an overall indication of the individual's subjective intoxication. A higher score would indicate greater feelings of impairment.
Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
General Labeled Magnitude Scale Questionnaire (gLMS)
Time Frame: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
The general labeled magnitude scale (gLMS) is a psychophysical scaling method used to measure the perceived intensity of various sensations. A gLMS typically ranges from 0 (undetectable) to 100 (strongest imaginable sensation/experience of any kind). Crucially, it uses specific labels positioned at specific points on the scale (e.g., barely detectable, weak, moderate, strong, very strong). The gLMS was comprised of 3 questions asking participants to indicate the overall flavor sensation, harshness, and throat hit of the e-cigarette. The score for each of the questions was summed. A higher score would indicate greater sensations from e-cigarette use.
Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Labeled Hedonic Scale Questionnaire (LHS)
Time Frame: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
A survey tool used to measure how much someone likes or dislikes something using descriptive labels for different levels of liking and disliking. Instead of just numbers, the scale uses words or phrases that describe the intensity of liking or disliking (e.g., "most disliked sensation imaginable"=0, "neutral" = 50, and "most liked sensation imaginable"=100) and aim to provide ratio-level data, meaning that the differences between scale points are meaningful and proportional. the LHS was comprised of 4 questions asking participants to indicate the e-cigarette's overall flavor sensation, harshness, throat hit, and warmth of the vapor. The score for each of the questions was summed. A higher score would indicate a more liked overall vaping experience; a lower score would indicate a more disliked overall vaping experience
Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Direct Effects of Vaping Questionnaire (DEPVQ)
Time Frame: Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).
Direct Effects of Vaping Questionnaire (DEVQ) is a 10-item Questionnaire that asks participants about their vaping experience (10 questions, each scored from 0 - 100). While subscale scores are often the primary focus, an overall score may be calculated by summing all item scores or averaging them. The score for each of the questions was summed. A higher score indicates the e-cigarette evoked greater subjective effects or feelings.
Administered at baseline, 55 minutes post-drinking (after first vape bout), and 215 minutes post-drinking (after second vape bout).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Department of Justice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison Breland, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM20018402
  • 2019-MU-MU-0007 (Other Grant/Funding Number: Department of Justice)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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