TRAC plus SAM for Alcohol Use Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alcohol Use Disorder+4 More
Tracking and Reducing Alcohol Consumption (TRAC) - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

Ecological momentary interventions (EMI), which use phones to deliver messages to reduce alcohol use and related risk behaviors during or prior to drinking events, can help to address triggers in real-time. GPS tracking can determine when individuals visit places they have previously reported drinking or triggers to drink and then EMI messages can be delivered upon arrival to prevent risky alcohol use. A mobile app has been developed that uses GPS tracking to determine when emerging adult sexual minority male and transgender (SMMTs) persons visit "risky" places and then delivers a survey asking what behaviors they engaged in while at the location. The goal of the proposed study is to use this app to enhance the Tracking and Reducing Alcohol Consumption (TRAC) intervention by delivering messages that encourage participants to employ strategies discussed during TRAC sessions when arriving at risky places. When they leave these places, they will complete a survey and breathalyzer reading in order to collect event-level self-report and biological data on alcohol use and HIV risk. If their breathalyzer result indicates alcohol use, they will receive harm reduction messaging. It is expected that combining TRAC with EMI ("GeoTRAC") will increase effectiveness by reinforcing topics discussed during these sessions, providing in-the-moment messaging to address triggers, and collecting real-time alcohol use data.

Eligible Conditions
  • Risky Behaviors
  • Alcohol Use Disorder
  • HIV Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 8 months (assessed up to 2x daily)

8 months
Alcohol consequences
Alcohol cravings
Ethanol
Concurrent sex and substance use
Condom attitudes
Condomless sex
Discrimination due to sexual/gender identity
Drinking refusal self-efficacy
Hazardous/harmful drinking
HIV
Alcohol Use Disorder
Drunk driving
Transactional sex
Month 8
Location characteristics - harassment/discrimination
Location characteristics - sexual activity
Location characteristics - substances
8 months (measured daily)
Alcohol withdrawal
Characteristics of sex partners
Number of binge drinking episodes
Drunk driving
PrEP use
Sexual activity
Month 8
Number of drinking days

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

TRAC plus SAM
1 of 3
GeoTRAC plus SAM
1 of 3
SAM-Only Comparison Group
1 of 3
Experimental Treatment

405 Total Participants · 3 Treatment Groups

Primary Treatment: TRAC plus SAM · No Placebo Group · N/A

TRAC plus SAMExperimental Group · 2 Interventions: Tracking and Reducing Alcohol Consumption (TRAC), Smartphone Based Alcohol Monitoring (SAM) · Intervention Types: Behavioral, Behavioral
GeoTRAC plus SAMExperimental Group · 3 Interventions: Tracking and Reducing Alcohol Consumption (TRAC), Smartphone Based Alcohol Monitoring (SAM), GeoTRAC · Intervention Types: Behavioral, Behavioral, Behavioral
SAM-Only Comparison Group
Behavioral
Experimental Group · 1 Intervention: Smartphone Based Alcohol Monitoring (SAM) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months (assessed up to 2x daily)

Who is running the clinical trial?

Carolyn LaucknerLead Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
710 Previous Clinical Trials
1,170,386 Total Patients Enrolled
Carolyn Lauckner, PhDPrincipal InvestigatorUniversity of Kentucky
2 Previous Clinical Trials
100 Total Patients Enrolled
Trace Kershaw, PhDPrincipal InvestigatorYale University

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male who identifies as a sexual minority male or as a transgender individual.
You are between the ages of 18-35 at the start of the study.
You own a smartphone.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.