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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days to 60 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Percent days abstinent via wrist biosensor readings

Other outcome measures

Percent days abstinent via self-report

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

~1970

mHealth

2014

Completed Phase 3

~1660

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Florida State UniversityOTHER

200 Previous Clinical Trials

31,638 Total Patients Enrolled

University of MiamiOTHER

902 Previous Clinical Trials

409,956 Total Patients Enrolled

5 Trials studying Alcoholism

1,296 Patients Enrolled for Alcoholism

University of LouisvilleOTHER

339 Previous Clinical Trials

76,560 Total Patients Enrolled

1 Trials studying Alcoholism

60 Patients Enrolled for Alcoholism

Media Library

mHealth Tools (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05153811 — N/A

Alcoholism Research Study Groups: mHealth and CM, Non-Contingent Condition, CM

Alcoholism Clinical Trial 2023: mHealth Tools Highlights & Side Effects. Trial Name: NCT05153811 — N/A

mHealth Tools (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05153811 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any more individuals being accepted into this experiment?

"According to clinicaltrials.gov, this medical experiment is presently seeking out eligible participants. It was initially posted on June 10th of 2022 and updated most recently on August 3rd of the same year."

Answered by AI

Could I be considered an appropriate candidate for this research endeavor?

"For acceptance into this trial, applicants must possess a history of alcohol intake and be between the ages of 35-70. The study is looking to enrol 120 potential participants in total."

Answered by AI

Does this research include those aged sixty and older?

"This clinical trial has established that the minimum age for enrollment is 35, while the upper limit of participation cannot exceed 70 years old."

Answered by AI

How many participants have been included in this clinical trial?

"Affirmative. Clinicaltrials.gov displays that this research is currently recruiting participants, having been published on June 10th 2022 and recently updated on August 3rd of the same year. The trial requires 120 individuals from two distinct sites to take part in the experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Less is More Study

2022. "The Less is More Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153811.