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Mobile App Intervention for Risky Alcohol Use (TRAC-ER Trial)

N/A
Waitlist Available
Led By Carolyn Lauckner, PhD
Research Sponsored by Carolyn Lauckner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months (assessed up to 2x daily)
Awards & highlights

Summary

This trial will use mobile apps to deliver messages to reduce risky drinking & HIV risk in sexual minority males & transgender persons. They'll also take surveys & breathalyzer readings to measure outcomes.

Who is the study for?
This trial is for sexual minority males and transgender individuals aged 18-35 who drink alcohol at risky levels, own a smartphone, are HIV-negative, meet CDC PrEP criteria, and identify as non-heterosexual. It's not for those who don't speak English, have severe alcohol withdrawal symptoms or mental illness, or need detox.
What is being tested?
The study tests the TRAC-ER app intervention that combines GPS tracking with ecological momentary interventions (EMI) to reduce risky alcohol use. When participants visit 'risky' places, they receive messages encouraging strategies from prior sessions and provide data on their drinking behavior.
What are the potential side effects?
Since this intervention involves behavioral strategies rather than medication, traditional side effects are not expected. However, participants may experience stress or discomfort when receiving real-time feedback about their behaviors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months (assessed up to 2x daily)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months (assessed up to 2x daily) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of drinking days
Secondary study objectives
Number of binge drinking episodes
Drunk driving
Other study objectives
Alcohol consequences
Alcohol cravings
Ethanol
+17 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: TRAC-ER plus SAMExperimental Treatment3 Interventions
Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention combined with GPS-based ecological momentary interventions (EMI) and smartphone-based alcohol monitoring.
Group II: TRAC plus SAMExperimental Treatment2 Interventions
Participants in this group will receive the Tracking and Reducing Alcohol Consumption (TRAC) intervention and smartphone-based alcohol monitoring.
Group III: SAM-Only Comparison GroupExperimental Treatment1 Intervention
Participants in this group will engage only in smartphone-based alcohol monitoring.

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,160,901 Total Patients Enrolled
Carolyn LaucknerLead Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
Carolyn Lauckner, PhDPrincipal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

TRAC-ER Clinical Trial Eligibility Overview. Trial Name: NCT05576350 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: SAM-Only Comparison Group, TRAC plus SAM, TRAC-ER plus SAM
Human Immunodeficiency Virus Infection Clinical Trial 2023: TRAC-ER Highlights & Side Effects. Trial Name: NCT05576350 — N/A
TRAC-ER 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576350 — N/A
~270 spots leftby May 2027
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