What is the mechanism of action of this treatment?

Common treatments for Substance Use Disorder (SUD) include cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and various telehealth interventions. CBT helps patients identify and modify negative thought patterns and behaviors associated with substance use, while MET focuses on enhancing an individual's motivation to change their substance use behavior. Telehealth interventions, such as remote counseling and support via videoconferencing or phone, improve access to these therapies by allowing patients to receive treatment from their homes. These mechanisms are crucial for SUD patients as they provide flexible, accessible, and effective support, which can lead to better engagement and outcomes in managing their substance use.

What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorder (SUD) include behavioral therapies like Cognitive Behavioral Therapy (CBT) and Motivational Enhancement Therapy (MET), which generally have minimal side effects but may cause temporary emotional discomfort as patients confront their behaviors. Pharmacological treatments such as topiramate can cause side effects like impaired concentration, confusion, dizziness, anxiety, and paresthesias, leading to higher dropout rates. Varenicline, another medication used for SUD, may cause nausea, insomnia, and abnormal dreams. Remote delivery of these treatments via telehealth platforms can also face challenges such as technical disruptions, privacy concerns, and difficulty in establishing a therapeutic alliance.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder (SUD). Naltrexone, available in both oral and depot formulations, is used for alcohol and opioid dependence. Buprenorphine, often combined with naloxone, is approved for opioid use disorder and can be prescribed via telemedicine. Varenicline, primarily approved for smoking cessation, has shown promise in treating alcohol and cannabis use disorders. These medications, along with telehealth interventions, provide comprehensive support for managing SUD remotely.

What other types of research exist?

Promising, novel alternatives to Telehealth for SUD patients in 2024 include: 1) Mobile health applications like the HOPE app, which supports communication between patients and care providers through secure messaging and community message boards. 2) Web-based interventions that are interactive and tailored to individual needs, such as those offered by Smokefree.gov. 3) Automated text messaging systems that provide appointment reminders, supportive messages, and relapse prevention content. 4) Digital platforms that facilitate social network support, such as Tweet2Quit and Facebook-based interventions.

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Telemedicine for Alcoholism

N/A

Recruiting

Led By Allison Lin, MD

Research Sponsored by University of Michigan

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

Conditions that preclude informed consent or understanding of assessment or intervention content

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new online program to help people manage their health and alcohol use. Participants will discuss what's important to them, set goals, and learn new skills. The aim is to find better ways to deliver useful health information.

Who is the study for?

This trial is for individuals with alcohol use disorder who drink on average three or more days per week, have access to a device with video capabilities or a phone, and can understand English. It's not suitable for those who've had recent AUD therapy, are at risk of complicated withdrawal, or have injected drugs in the past year.

What is being tested?

The study compares two programs: TeleTx intervention delivered via telehealth platforms like Zoom and Enhanced Usual Care (EUC). Participants will be randomly assigned to one of these groups and followed up for up to 12 months to see which program better helps manage health behaviors related to alcohol use.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort discussing personal issues during sessions.

Eligibility Criteria

Exclusion Criteria

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

Select...

I am able to understand and consent to the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Alcohol Use Disorder Treatment Engagement

Alcohol Use Disorder Treatment Initiation

Alcohol consumption days

+1 more

Secondary study objectives

Alcohol consequences

Drinking Risk Levels (Based on World Health Organization Cut-Offs)

Total Alcohol Use Disorder Psychotherapy Treatment Attendance

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TeleTx interventionExperimental Treatment1 Intervention

The evidence-based manualized psychosocial program is via telehealth and uses adaptations of cognitive behavioral therapy and motivational interviewing.

Group II: Enhanced Usual Care (EUC)Active Control1 Intervention

EUC will include brief psychoeducation about AUD and resources for treatment.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Substance Use Disorder (SUD) include cognitive-behavioral therapy (CBT), motivational enhancement therapy (MET), and various telehealth interventions. CBT helps patients identify and modify negative thought patterns and behaviors associated with substance use, while MET focuses on enhancing an individual's motivation to change their substance use behavior. Telehealth interventions, such as remote counseling and support via videoconferencing or phone, improve access to these therapies by allowing patients to receive treatment from their homes. These mechanisms are crucial for SUD patients as they provide flexible, accessible, and effective support, which can lead to better engagement and outcomes in managing their substance use.

A clinical trial on a brief motivational intervention in reducing alcohol consumption under a telehealth supportive counseling.Profile of cases discussed in innovative tele-ECHO mentoring program on addiction management.Cognitive functioning and treatment outcomes in a randomized controlled trial of internet-delivered drug and alcohol treatment.