High Risk DrinkingNCT07307326
Biomarker Feedback Intervention
A study testing eCHECKUP TO GO (eCTG) and eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC) in people with High Risk Drinking and College Student Drinking, run by Penn State University at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- High Risk Drinking, College Student Drinking
- What is being tested?
- eCHECKUP TO GO (eCTG) and eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Younger than 18 at baseline
- Not fluent in English
- No Internet access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Pennsylvania State University
University Park, Pennsylvania, 16802
Kimberly Mallett, PhD, 814-441-6398, kmallett@psu.edu
Rob Turrisi, PhD, 814-865-7808, rturrisi@psu.edu
About this study
Official title: 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.
- Conditions
- High Risk Drinking, College Student Drinking
- Being tested
- eCHECKUP TO GO (eCTG), eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)
- Keywords
- college student drinking
- Medical subject headings
- Alcohol Drinking in College
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCHECKUP TO GO (eCTG)Behavioural
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
eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| eCHECKUP TO GO (eCTG) | Experimental | 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 Receives: Behavioral: eCHECKUP TO GO (eCTG) |
| eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC) | Experimental | 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. Receives: Behavioral: eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine changes in Transdermal Alcohol Concentration (TAC) rise rate
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.
Measured: Baseline, 6 months
Examine changes in Transdermal Alcohol Concentration (TAC) peak intoxication level
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.
Measured: Baseline, 6 months
Examine high risk drinking days
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.
Measured: Baseline, 6 months
Secondary outcomes (2)
Examine negative consequences of alcohol use
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.
Measured: Baseline, 6 months
Examine Alcohol Use Disorder (AUD) symptoms
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).
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group receives the e-CTG + TAC feedback and the second group receives the e-CTG-only.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Mallett, Penn State University
- Investigators
- Kimberly Mallett, PhD, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307326
- Sponsor's protocol ID
- STUDY00027939
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of funding requirements, data collected will be submitted to the NIAAA Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of the Feasibility of a Brief Personalized Alcohol Biomarker Feedback Intervention for High-risk College Students
- ClinicalTrials.gov ID
- NCT07307326
- Acronym / sponsor ID
- STUDY00027939
- Conditions
- High Risk Drinking, College Student Drinking
- Keywords
- college student drinking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The first group receives the e-CTG + TAC feedback and the second group receives the e-CTG-only.
| Arm | Type | Receives |
|---|---|---|
| eCHECKUP TO GO (eCTG) | Experimental | 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 |
| eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC) | Experimental | 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. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Younger than 18 at baseline
- Not fluent in English
- No Internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | eCHECKUP TO GO (eCTG) |
| 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. | Behavioural | eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Examine negative consequences of alcohol use
Time frame: Baseline, 6 months
Examine Alcohol Use Disorder (AUD) symptoms
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Yes. As part of funding requirements, data collected will be submitted to the NIAAA Data Archive.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Mallett, PhD principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCHECKUP TO GO (eCTG) and eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC) in people with High Risk Drinking and College Student Drinking, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Mallett, PhD (814-441-6398, kmallett@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine changes in Transdermal Alcohol Concentration (TAC) rise rate (time frame: Baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.