Biomarker Feedback Intervention

December 15, 2025 updated by: Kimberly Mallett, Penn State University

An Examination of the Feasibility of a Brief Personalized Alcohol Biomarker Feedback Intervention for High-risk College Students

The goal of the study is to examine alcohol use behaviors of young adults through the use of testing the feasibility of adding an innovative brief personalized alcohol biomarker feedback component (TAC feedback) to an existing efficacious personalized feedback intervention, eCHECKUP TO GO (eCTG), and how (if at all) the intervention impacts drinking behaviors in high-risk college students. The study will conduct a feasibility assessment of the TAC feedback component, and will also assess the effects of the eCTG + TAC at 6-months post-baseline relative to an eCTG only group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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 (Estimated)

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.
150

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: Kimberly Mallett, PhD
  • Phone Number: 814-441-6398
  • Email: kmallett@psu.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • The Pennsylvania State University
        • Contact:
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Between the ages of 18-23 at enrollment
  • Endorse drinking 4+/5+ (women/men) on a typical Friday or Saturday in the past 3-months
  • Report at least 1 alcohol-induced blackout in the past 3-months
  • Willing to wear a TAC sensor for 14 days at Waves 1 and 2

Exclusion Criteria:

  • Younger than 18 at baseline
  • Not fluent in English
  • No Internet access

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: eCHECKUP TO GO (eCTG)
A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol
Behavioral: eCHECKUP TO GO (eCTG)
A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol
Experimental: eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC)
Participants will receive the eCHECKUPTOGO in addition to the transdermal alcohol concentration (TAC) personalized feedback. The TAC is a brief individually delivered intervention based on the principles of Motivational Interviewing and focuses on increasing students' motivation to reduce harmful drinking by drinking in a safer, less risky manner. Participants will receive information on their drinking (both from the TAC sensor and daily diary data). Participants will be asked about drinking events during the past 2 weeks (how reflective they were of typical patterns and if a night stood out as particularly negative). Students will receive information and visual representations about TAC rise rates and peaks, and then be shown how their drinking during the past 2 weeks maps onto those visuals.
Behavioral: eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)
Participants will receive the eCHECKUPTOGO in addition to the transdermal alcohol concentration (TAC) personalized feedback. The TAC is a brief individually delivered intervention based on the principles of Motivational Interviewing and focuses on increasing students' motivation to reduce harmful drinking by drinking in a safer, less risky manner. Participants will receive information on their drinking (both from the TAC sensor and daily diary data). Participants will be asked about drinking events during the past 2 weeks (how reflective they were of typical patterns and if a night stood out as particularly negative). Students will receive information and visual representations about TAC rise rates and peaks, and then be shown how their drinking during the past 2 weeks maps onto those visuals.

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
Examine changes in Transdermal Alcohol Concentration (TAC) rise rate
Time Frame: Baseline, 6 months
TAC rise rate will be collected via the BACtrack Skyn wrist sensor, which measures transdermal alcohol concentration (TAC) in micrograms of ethanol per liter of air every 20 seconds to obtain biomarkers - rise rate is a TAC increase.
Baseline, 6 months
Examine changes in Transdermal Alcohol Concentration (TAC) peak intoxication level
Time Frame: Baseline, 6 months
TAC peak will be collected via the BACtrack Skyn wrist sensor, which measures transdermal alcohol concentration (TAC) in micrograms of ethanol per liter of air every 20 seconds to obtain biomarkers - peak is the maximum TAC recorded per day.
Baseline, 6 months
Examine high risk drinking days
Time Frame: Baseline, 6 months
Heavy episodic drinking (HED) days are recorded when women indicate drinking 4+ drinks in 2 hour window/men indicate drinking 5+ drinks in 2 hour window. High-intensity drinking (HID) days are recorded when women indicate drinking 8+ drinks in 2 hour window/men indicate drinking 10+ drinks in 2 hour window.
Baseline, 6 months

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
Examine negative consequences of alcohol use
Time Frame: Baseline, 6 months
Alcohol related consequences (e.g., said or done embarrassing things) from the past 3 months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire. Response options will be on a 5-point scale ranging from (0) No or not in the past 3 months to (4) 4 or more times. Consequences will also be measures during the daily surveys on a Yes/No response scale.
Baseline, 6 months
Examine Alcohol Use Disorder (AUD) symptoms
Time Frame: Baseline, 6 months
Alcohol use disorder symptoms will be measured using the Alcohol Use Disorder Module of the SCID-5 and will be via in-person interview at baseline (past 12-months) and 6-month (past 6-months).
Baseline, 6 months

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.
Penn State University

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: Kimberly Mallett, PhD, The Pennsylvania State 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 (Estimated)

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.
March 15, 2026

Primary Completion (Estimated)

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.
May 15, 2027

Study Completion (Estimated)

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.
May 15, 2027

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).
December 15, 2025

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.
December 15, 2025

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.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

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.
December 29, 2025

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 15, 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

Keywords

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.
  • STUDY00027939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As part of funding requirements, data collected will be submitted to the NIAAA Data Archive.

IPD Sharing Access Criteria

Individuals will request access to the data via a data access request through the data archive.

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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