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Biomarker Feedback Intervention

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07307326
Enrollment
150
Registered
2025-12-29
Start date
2026-10-15
Completion date
2027-12-15
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

College Student Drinking, High Risk Drinking

Keywords

college student drinking

Brief 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) 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.

Interventions

BEHAVIORALeCHECKUP 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

BEHAVIORALeCHECKUPTOGO + 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.

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention model description

The first group receives the e-CTG + TAC feedback and the second group receives the e-CTG-only.

Eligibility

Sex/Gender
ALL
Age
18 Years to 23 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Examine changes in Transdermal Alcohol Concentration (TAC) rise rateBaseline, 6 monthsTAC 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 levelBaseline, 6 monthsTAC 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 daysBaseline, 6 monthsHeavy 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.

Secondary

MeasureTime frameDescription
Examine negative consequences of alcohol useBaseline, 6 monthsAlcohol 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.
Examine Alcohol Use Disorder (AUD) symptomsBaseline, 6 monthsAlcohol 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).

Countries

United States

Contacts

CONTACTKimberly Mallett, PhD
kmallett@psu.edu814-441-6398
CONTACTRob Turrisi, PhD
rturrisi@psu.edu814-865-7808
PRINCIPAL_INVESTIGATORKimberly Mallett, PhD

The Pennsylvania State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026