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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months (assessed up to 2x daily)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months (assessed up to 2x daily)
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,365 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am between 18 and 35 years old.I identify as a sexual minority male or as transgender.I am currently in detox for substance use and require medical help.You have a smartphone.I identify as a male not exclusively attracted to women or I am transgender.You meet the eligibility criteria set by the CDC for taking PrEP medication.
Research Study Groups:
This trial has the following groups:- Group 1: SAM-Only Comparison Group
- Group 2: TRAC plus SAM
- Group 3: TRAC-ER plus SAM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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