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

Trial Summary

What is the purpose of this trial?

Participants with alcohol use disorder will be randomly assigned to either the Ria Treatment Platform or a waitlist control. The Ria Treatment Platform is a telehealth approach that incorporates medical assessment, medications for alcohol use disorder, individual and group coaching, educational video modules, and a Bluetooth-enabled breathalyzer. Patients are followed for three months during which data are collected, including measures of alcohol consumption and its consequences.

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 data supports the effectiveness of the Ria Treatment Platform for alcohol use disorder?

Research shows that the Ria Treatment Platform, a telehealth program for alcohol use disorder, led to significant reductions in blood alcohol concentration over 90 days. Additionally, patients reported high satisfaction and engagement with the telehealth approach, suggesting it is an effective way to reduce drinking. ^{1 2 3 4 5}

Is the telehealth treatment for alcohol use disorder safe for humans?

The safety of treatments for alcohol use disorder, like naltrexone and acamprosate, has been studied, showing they are generally safe for humans. Extended-release naltrexone, in particular, is noted to be safe and effective for active drinkers. ^{6 7 8 9 10}

How is the Ria Treatment Platform for alcohol use disorder different from other treatments?

The Ria Treatment Platform is unique because it offers a comprehensive telehealth approach through a smartphone app, combining physician visits, medication prescriptions, support from a recovery coach, video monitoring of medication adherence, and Bluetooth-linked breathalyzer tracking. This makes it more accessible and patient-centered compared to traditional face-to-face treatments. ^{3 4 11 12 13}

Research Team

John Mendelson, MD

Principal Investigator

Ria Health

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Telehealth service delivery for persons with alcoholism. [2007]

2. England pubmed.ncbi.nlm.nih.gov

High- versus low-intensity internet interventions for alcohol use disorders: results of a three-armed randomized controlled superiority trial. [2021]

3. England 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. [2023]

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

A novel telehealth platform for alcohol use disorder treatment: preliminary evidence of reductions in drinking. [2021]

5. Australia pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary effectiveness of internet-mediated 'relapse prevention therapy' for patients with alcohol use disorder: A pilot study. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Novel Agents for the Pharmacological Treatment of Alcohol Use Disorder. [2022]

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

Choosing the right medication for the treatment of alcoholism. [2022]

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

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

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

The COMBINE SAFTEE: a structured instrument for collecting adverse events adapted for clinical studies in the alcoholism field. [2019]

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

Extended-release naltrexone and harm reduction counseling for chronically homeless people with alcohol dependence. [2022]

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

Telemedicine-based alcohol services for rural offenders. [2021]

12. Canada 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. [2023]

13. Ireland pubmed.ncbi.nlm.nih.gov

The remote brief intervention and referral to treatment model: Development, functionality, acceptability, and feasibility. [2018]