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Behavioral Intervention

mHealth + Counseling for Alcoholism

N/A

Recruiting

Led By Robert Leeman, Ph.D

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Pregnancy, nursing or lack of reliable birth control use for women who have not yet reached menopause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days to 60 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new way to help people with HIV who also struggle with alcohol use. The treatment will use a smartphone breathalyzer device and a wrist worn alcohol biosensor to help people cut back on drinking.

Who is the study for?

This trial is for people living with HIV who frequently drink heavily, are willing to try not drinking for at least 30 days, and then reduce their alcohol use. They must be comfortable using smartphone apps and a wrist sensor to monitor their drinking. Those with severe psychiatric conditions, current alcohol withdrawal symptoms, or recent intensive addiction treatment are excluded.

What is being tested?

The study tests mobile health tools—a smartphone breathalyzer app and a wrist-worn alcohol biosensor—to encourage less drinking among participants over a period of up to six months. The goal is to see if these mHealth innovations can help reduce alcohol consumption in individuals living with HIV.

What are the potential side effects?

Since the interventions involve counseling and use of mHealth tools rather than medications, traditional side effects are not expected. However, participants may experience discomfort or inconvenience from regular monitoring of their alcohol intake.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, nursing, and I use reliable birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days to 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days to 60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drinking reduction through Contingency Management will predict non-drinking outcomes

Perceived value and ease of use of novel contingency management strategies to reduce alcohol consumption.

Percent days abstinent via smartphone breathalyzer readings

+1 more

Secondary study objectives

Percent days abstinent via wrist biosensor readings

Other study objectives

Percent days abstinent via self-report

Awards & 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: mHealth and CMExperimental Treatment2 Interventions

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings. Participants will also interact with a mobile health application to facilitate drinking reduction.

Group II: Non-Contingent ConditionExperimental Treatment1 Intervention

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, encouragement to reduce drinking but payment not based on drinking.

Group III: CMExperimental Treatment1 Intervention

Participants will wear a wrist biosensor with daily CM based on smartphone breathalyzer readings for 30 days; then for a second 30 days, weekly CM based on wrist biosensor readings

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Counseling

2017

Completed Phase 4

~1830

mHealth

2014

Completed Phase 3

~1900