mHealth + Counseling for Alcoholism

Recruiting at 1 trial location

Overseen By Emmely Pavila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Psychiatric conditions, Alcohol withdrawal, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

What is the purpose of this trial?

In this project, the investigators will implement innovations to extend use of Contingency Management (CM) to facilitate alcohol use reduction among people living with HIV (PLWH). The investigators' approach to extending CM will use mobile health (mHealth) tools including a smartphone breathalyzer device with accompanying app and a wrist worn alcohol biosensor. Participants will be engaged in mobile facilitated CM for 30-60 days with follow-up out to 6 months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on alcohol use reduction and does not mention any medication restrictions.

What data supports the effectiveness of this treatment for alcoholism?

Research shows that smartphone apps can help reduce alcohol consumption by providing real-time feedback and self-monitoring tools. In particular, studies have found that using a smartphone app alongside counseling can lead to significant reductions in drinking and its consequences. ^{1 2 3 4 5}

Is the mHealth + Counseling treatment for alcoholism safe for humans?

The studies reviewed focus on the feasibility and acceptability of using mobile health tools and wearable devices for alcohol monitoring, but they do not report any specific safety concerns for humans. ^{1 2 4 6 7}

How is the mHealth + Counseling treatment for alcoholism different from other treatments?

The mHealth + Counseling treatment for alcoholism is unique because it uses mobile health tools like smartphone apps and wearable devices to monitor alcohol use in real-time, providing immediate feedback to help reduce risky drinking behavior. This approach combines technology with counseling, offering a more interactive and accessible way to manage alcohol use compared to traditional in-person methods. ^{1 2 3 4 8}

Research Team

Robert Leeman, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Inclusion Criteria

Willingness to use smartphone applications and biosensor devices (i.e., breathalyzer device and wrist sensor) for alcohol use reduction purposes in the study. If participants do not have a compatible smartphone to use, they will be loaned one by the study

HIV positive

Fluency in English

Exclusion Criteria

Currently seeking or past-12-month history of inpatient or intensive treatment for addictive behaviors

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

Psychiatric conditions that would interfere with participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants engage in daily Contingency Management using a smartphone breathalyzer for 30 days

4 weeks

Daily virtual interactions

Treatment Phase 2

Participants engage in weekly Contingency Management using a wrist biosensor for an additional 30 days

4 weeks

Weekly virtual interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic virtual check-ins

Treatment Details

Interventions

• Counseling
• mHealth Tools

Trial Overview 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.

Participant Groups

Group I: mHealth and CM Experimental Treatment 2 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 Condition Experimental Treatment 1 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: CM Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Florida State University

Collaborator

Trials

234

Recruited

41,100+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

A survey of 139 participants showed strong interest in using a mobile health application that monitors blood alcohol concentration (BAC) through gait analysis, indicating potential for reducing risky drinking behaviors.

Participants expressed a desire for control over app features, with adults preferring the option to disable BAC monitoring, while females favored mandatory notifications and safety features, highlighting the importance of user preferences in app design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. Borges, A., Caviness, C., Abrantes, AM., et al.[2023]

A smartphone application designed to help reduce unhealthy alcohol use was found to be acceptable and useful among 130 adults, with significant reductions in weekly drinking (from 15.0 to 10.9 drinks/week) and binge drinking (from 95.4% to 64.3%) after 3 months.

Participants who used the application more than once reported a 30% reduction in weekly alcohol consumption, indicating that increased engagement with the app may lead to better drinking outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. Bertholet, N., Daeppen, JB., McNeely, J., et al.[2022]

A study involving 99 young adults showed that using mobile health technologies, like a smartphone breathalyzer and a BAC estimator app, was feasible and well-accepted for moderating drinking habits.

Participants reported a significant reduction in alcohol consumption during a 2-week field test, using the technologies on 67% of drinking days, suggesting these tools may help reduce heavy drinking among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Leeman, RF., Berey, BL., Frohe, T., et al.[2023]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

In a pilot study with six participants over 9 weeks, the use of a smartphone app and breathalyzer significantly increased the submission of alcohol-negative breathalyzer samples during the contingency management phase (49%) compared to the noncontingent phases (27%), indicating the potential efficacy of this intervention.

Participants reported mixed usability experiences with the app, highlighting some technical issues, which suggests that while the technology shows promise for managing alcohol use, improvements in usability are needed for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use. Oluwoye, O., Reneau, H., Herron, J., et al.[2022]

The study demonstrated that BACtrack Skyn wearable alcohol monitors are feasible and acceptable for use among college students, with all participants successfully using the devices over a 5 to 7-day period, generating a total of 11,504 hours of transdermal alcohol content (TAC) data.

Participants reported high levels of satisfaction with the monitors, achieving a mean score of 4.3 out of 5 on both the Feasibility of Intervention Measure and the Acceptability of Intervention Measure, indicating strong potential for these devices in alcohol research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable alcohol monitors for alcohol use data collection among college students: Feasibility and acceptability. Rosenberg, M., Kianersi, S., Luetke, M., et al.[2023]

This study evaluates the effectiveness of a wireless breathalyzer in conjunction with long-term treatment for alcohol use disorder, focusing on its impact on dropout rates, psychological distress, treatment motivation, and quality of life over a 3-month period with follow-up.

The randomized clinical trial will compare outcomes between participants with access to the wireless breathalyzer and those without, aiming to determine if ongoing monitoring can improve treatment adherence and reduce the need for higher levels of follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. Buono, FD., Gleed, C., Boldin, M., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Smartphone application for unhealthy alcohol use: A pilot study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot Study of an Integrated Smartphone and Breathalyzer Contingency Management Intervention for Alcohol Use. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Wearable alcohol monitors for alcohol use data collection among college students: Feasibility and acceptability. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. [2022]