Telehealth Treatment for Alcohol Use Disorder

Overseen By LaTrice Montgomery, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ria Health

Disqualifiers: Inability to provide informed consent

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new telehealth method to assist people with alcohol use disorder. The treatment, known as the Ria Treatment Platform, includes online medical check-ups, medication, personal and group coaching, educational videos, and a home-use breathalyzer. Participants will be divided into two groups: one will try the new treatment, while the other will remain on a waitlist. This trial suits those who have struggled with alcohol use disorder. As an unphased trial, it offers a unique opportunity to access innovative treatment methods and contribute to advancing care for alcohol use disorder.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ria Treatment Platform is safe for treating alcohol use disorder?

Research shows that the Ria Treatment Platform, a telehealth method for treating alcohol use disorder, is generally well-tolerated. Studies have found that people using this platform significantly reduced their alcohol consumption. Although specific side effects aren't listed, the program includes medical check-ups and prescriptions for medications commonly used to treat alcohol use disorder. These medications are usually safe when taken as directed. The platform also provides online coaching and a Bluetooth breathalyzer to track progress, offering extra support without added safety concerns. Overall, existing evidence suggests this treatment is safe for most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Ria Treatment Platform is unique because it offers a comprehensive telehealth approach to treating alcohol use disorder, combining medical assessments, personalized medication prescriptions, coaching, and educational resources. Unlike traditional treatments that often require in-person visits, the Ria platform allows for remote access, making it more convenient and accessible. Researchers are excited about this treatment because it integrates technology with healthcare, utilizing a Bluetooth-enabled breathalyzer for real-time monitoring, which could lead to more personalized and effective care.

What evidence suggests that the Ria Treatment Platform is effective for alcohol use disorder?

Research has shown that the Ria Treatment Platform, which participants in this trial may receive, can greatly help people with alcohol use disorder reduce their drinking. This platform combines medical check-ups, medications, coaching, educational videos, and a Bluetooth breathalyzer to manage drinking habits. In past studies, individuals using this online approach significantly reduced their alcohol consumption. The Ria Treatment Platform tailors support to each person, helping them either reduce or stop drinking. These results suggest that the platform effectively addresses alcohol-related problems. ^{2 3 4 6 7}

Who Is on the Research Team?

John Mendelson, MD

Principal Investigator

Ria Health

Are You a Good Fit for This Trial?

This trial is for individuals with alcohol use disorder. Participants will be chosen randomly to either start the Ria Treatment Platform right away or be placed on a waitlist. The key requirement is having an alcohol use disorder; other specific criteria aren't listed.

Inclusion Criteria

Alcohol use disorder

Exclusion Criteria

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Ria Treatment Platform, a telehealth approach including medical assessment, medications, coaching, educational modules, and breathalyzer monitoring

12 weeks

Telehealth sessions as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of alcohol consumption

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ria Treatment Platform

Trial Overview

The study tests the Ria Treatment Platform, a telehealth service that includes medical assessments, medication, coaching sessions, educational content, and breathalyzer monitoring for three months against no immediate treatment (waitlist).

How Is the Trial Designed?

Group I: Ria Treatment Platfrom Experimental Treatment 1 Intervention

The Ria Treatment Platform is a telehealth approach that includes medical assessment, prescription of clinically appropriate medications for alcohol use disorder, individual and group coaching, educational video modules, and monitoring of breath alcohol concentrations through a Bluetooth-enabled breathalyzer.

Group II: waitlist control Active Control 1 Intervention

Patients in this arm will not be provided treatment during the study period.

Who Is Running the Clinical Trial?

Ria Health

Lead Sponsor

Trials

2

Recruited

160+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

Pharmacotherapy, combined with psychosocial interventions, is an important approach for treating alcohol dependence, with four FDA-approved medications (disulfiram, acamprosate, oral naltrexone, and extended-release naltrexone) showing varying effectiveness in reducing alcohol consumption and increasing abstinence.

While these medications can help, their effectiveness is often modest and affected by factors like patient adherence and the complexity of alcohol dependence, suggesting a need for better understanding of the condition and strategies to improve treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of pharmacotherapy for the treatment of alcohol dependence. Garbutt, JC.[2018]

A 12-week pilot study involving 31 chronically homeless individuals with alcohol dependence showed that extended-release naltrexone (XR-NTX) combined with harm reduction counseling was well-accepted and feasible for this population.

Participants experienced significant reductions in alcohol craving (33%), typical use (25%), peak use (34%), frequency of drinking (17%), and alcohol-related problems (60%), indicating that this approach may effectively support harm reduction goals without requiring abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-release naltrexone and harm reduction counseling for chronically homeless people with alcohol dependence. Collins, SE., Duncan, MH., Smart, BF., et al.[2022]

Telemedicine, specifically through videoconferencing, is being used to effectively deliver motivational enhancement therapy to at-risk alcohol users in rural areas, where access to treatment is often limited.

This approach not only addresses the lack of evidence-based substance abuse treatment in rural communities but also tailors interventions to the specific needs of at-risk groups, enhancing the potential for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. Staton-Tindall, M., Wahler, E., Webster, JM., et al.[2021]

Recent advancements in understanding the neurobiology of alcohol disorders have led to the development of four FDA-approved medications for alcohol dependence, which significantly enhance treatment outcomes compared to traditional counseling alone.

The approved medications include disulfiram, oral naltrexone, acamprosate, and an extended-release injectable form of naltrexone, with ongoing research exploring additional options like topiramate and quetiapine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choosing the right medication for the treatment of alcoholism. Pettinati, HM., Rabinowitz, AR.[2022]

This study will compare the effectiveness of a web-based relapse prevention therapy (e-RPT) to traditional face-to-face therapy (RPT) for adults with alcohol use disorder (AUD), involving 60 participants over 10 sessions.

The research aims to demonstrate that e-RPT can reduce relapse rates and improve quality of life, self-efficacy, and resilience, while also being more accessible and cost-effective than traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Implementing a Web-Based Relapse Prevention Psychotherapy Program for Patients With Alcohol Use Disorder: Protocol for a Randomized Controlled Trial. Eadie, J., Gutierrez, G., Moghimi, E., et al.[2023]

The Ria Treatment Platform (RTP) is a novel telemedicine program for treating alcohol use disorder (AUD) that combines physician visits, medication, and support through a smartphone app, showing a 50% reduction in average blood alcohol content (BAC) among engaged patients over 90 days.

With a treatment retention rate of 55% at 90 days, the RTP demonstrates promising efficacy in reducing alcohol use, highlighting the potential of integrating technology and medical support in AUD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel telehealth platform for alcohol use disorder treatment: preliminary evidence of reductions in drinking. Mitchell, MM., Mendelson, J., Gryczynski, J., et al.[2021]

The Remote Brief Intervention and Referral to Treatment (R-BIRT) model was found to be feasible, with a 40% acceptance rate among 125 eligible emergency department patients, indicating potential for wider implementation.

Patients who received consultations during their emergency department visit had a significantly higher completion rate of 90% compared to only 10% for those contacted after their visit, suggesting that immediate intervention may enhance engagement in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. Boudreaux, ED., Haskins, B., Harralson, T., et al.[2018]

The study involved 18 participants with alcohol use disorders who received eight sessions of group therapy via videoconferencing over four weeks, with 14 completing at least four sessions and assessments.

Participants reported high satisfaction with the telepsychiatry service, comparable attendance rates to traditional therapy, and 82% would recommend the service, indicating that videoconferencing is a feasible and effective method for delivering therapy to individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth service delivery for persons with alcoholism. Frueh, BC., Henderson, S., Myrick, H.[2007]

A pilot study involving 32 adult men with alcohol use disorder showed that synchronous internet-mediated relapse prevention therapy (i-RPT) is feasible and acceptable, with 71.9% of participants completing all five sessions.

The therapy demonstrated modest effectiveness, leading to significant increases in days of abstinence and reductions in alcohol consumption, craving, and maladaptive coping behaviors, suggesting it could be a valuable tool for managing alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of internet-mediated 'relapse prevention therapy' for patients with alcohol use disorder: A pilot study. Sharma, A., Das, K., Sharma, S., et al.[2022]

Alcohol use disorder (AUD) is common but often under-treated, with only three approved medications, highlighting the need for more diverse and effective treatment options.

The review discusses various pharmacotherapies, including both approved and novel agents, showing promise for improving treatment efficacy and supporting personalized medicine approaches for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. Burnette, EM., Nieto, SJ., Grodin, EN., et al.[2022]

A study involving 166 adults with alcohol use disorder found that a therapist-guided high-intensity internet intervention did not significantly outperform an unguided low-intensity intervention in reducing alcohol consumption at the 6-month follow-up.

Both interventions had low rates of negative effects (8-14%) and deterioration (3-5%), indicating that they were relatively safe options for participants seeking help with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. Sundström, C., Eék, N., Kraepelien, M., et al.[2021]

The COMBINE Study successfully adapted the Systematic Assessment for Treatment Emergent Events (SAFTEE) to standardize the assessment of adverse events for naltrexone and acamprosate in treating alcohol dependence, ensuring consistent and reliable data collection.

The SAFTEE demonstrated high fidelity and flexibility in measuring adverse events across various settings, suggesting it could be a valuable tool for future clinical studies evaluating the safety and efficacy of new therapeutic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. Johnson, BA., Ait-Daoud, N., Roache, JD.[2019]

In a study of 4121 patients receiving alcohol use disorder treatment via telehealth, 50.1% retained treatment for 90 days, indicating a significant level of engagement with the program.

Patients showed a substantial reduction in daily estimated peak blood alcohol concentration (BAC), decreasing from a mean of 0.092 on day 1 to 0.038 by day 90, demonstrating the efficacy of telehealth in promoting drinking reductions across various patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment retention and reductions in blood alcohol concentration (BAC) during the first 90 days of a telehealth program for alcohol use disorder. Hallgren, KA., Galloway, GP., Witkiewitz, K., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31596648/

A novel telehealth platform for alcohol use disorder treatment

This study provides preliminary evidence of substantial alcohol use reductions among patients utilizing the RTP, an innovative telemedicine ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05747703

Telehealth Treatment for Alcohol Use Disorder

Details for study NCT05747703, | ClinicalTrials.gov.

3.

reporter.nih.gov

reporter.nih.gov/project-details/10924029

Project Details - NIH RePORTER

PROJECT NARRATIVE The Ria Treatment Platform is an innovative model for personalized alcohol use disorder treatment using telemedicine that includes anti ...

4.

riahealth.com

riahealth.com/

Ria Health: Online Alcohol Treatment Program

Ria Health's online alcohol treatment program uses anti-craving medication, BAC monitoring, & online coaching to help you reduce or quit drinking.

5.

withpower.com

withpower.com/trial/phase-alcoholism-4-2023-6f5b4

Telehealth Treatment for Alcohol Use Disorder

This N/A medical study run by Ria Health is evaluating whether Ria Treatment Platform will have tolerable side effects & efficacy for patients with Alcohol ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05747703

Telehealth Treatment for Alcohol Use Disorder

Details for study NCT05747703, | ClinicalTrials.gov.

7.

trialx.com

trialx.com/clinical-trials/listings/293239/telehealth-treatment-for-alcohol-use-disorder/?&radius=10&place=All%20Participating%20Sites&user_country=Germany

Telehealth Treatment for Alcohol Use Disorder

Study details. Conditions. Alcohol Use Disorder, Alcohol Dependence, Alcoholism. Clinical Study Identifier. NCT05747703. Sponsor. Ria Health.