Virtual Care Strategies for Alcoholism

Overseen By Erin Bonar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cancer, Complex alcohol withdrawal, others

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests various tech-based programs to help individuals manage alcohol use and overall health. It aims to determine if virtual tools, such as phone calls and online portals, can facilitate goal-setting and skill use to enhance well-being. Participants will try different combinations of these tools, including Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) and medications like Naltrexone, to identify the most effective approach. Ideal candidates for the trial are those with alcohol use disorder (AUD) who have recently engaged in heavy drinking and have access to the internet and a phone. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to advancing care for alcohol use disorder.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining Motivational Interviewing with Cognitive Behavioral Therapy (MI-CBT) is generally safe and well-tolerated for treating alcohol use issues. Studies indicate that MI-CBT helps individuals become more aware of their drinking habits and boosts their confidence in managing these behaviors. No major safety concerns have been reported for this approach.

Portal Engagement and Telephone Engagement primarily involve communication and information sharing. They do not use drugs or involve invasive procedures, resulting in a very low risk of harm. These techniques assist individuals in setting goals and managing their health more effectively, with no evidence suggesting they are unsafe.

Overall, these treatment methods are considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative virtual care strategies for alcoholism, which could offer more flexibility and accessibility than traditional treatments like in-person therapy or medication-assisted treatment. The trial examines different combinations of telehealth and digital engagement methods, such as Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) delivered via telehealth, and enhanced telephone or portal engagements. These approaches are unique because they allow for personalized treatment delivery in the comfort of one's home, potentially increasing patient engagement and adherence. By utilizing technology, the trial aims to find effective ways to support individuals in managing their alcohol use and improve outcomes in a more convenient manner.

What evidence suggests that this trial's treatments could be effective for managing alcohol use?

This trial will evaluate different virtual care strategies for alcoholism. Participants may receive Motivational Interviewing combined with Cognitive Behavioral Therapy (MI-CBT). Research has shown that MI-CBT effectively increases awareness of drinking problems and boosts confidence in managing drinking habits. Studies have found that MI-CBT reduces alcohol use by increasing motivation and teaching necessary skills for change.

Another treatment arm involves Portal Engagement. Although direct evidence is limited, similar online tools have shown promise in keeping patients engaged and supporting behavior change. These platforms can provide helpful resources and reminders to maintain focus on recovery goals.

Participants may also be assigned to the Telephone Engagement arm, which supports individuals with alcohol use disorders through regular check-ins and encouragement. This method helps participants stay connected and accountable, potentially leading to better treatment outcomes. Overall, these strategies aim to offer support and resources to manage alcohol use effectively. ^{2 6 7 8 9}

Who Is on the Research Team?

Erin Bonar

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have recently engaged in heavy alcohol use and have access to a phone and the internet. They must be able to understand and consent to participate. People are excluded if they don't speak English, can't consent, recently had alcohol use disorder treatment, might experience complex withdrawal symptoms, or are part of another related study.

Inclusion Criteria

Past month heavy alcohol use

Phone access

Internet access

Exclusion Criteria

Inability to speak or understand English

Recent AUD treatment

History of or at risk for complex alcohol withdrawal

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

First Stage Intervention

Participants engage in either Telephone or Portal Engagement

4 weeks

Virtual engagement

Second Stage Intervention

Participants receive either Telehealth MI-CBT program, Enhanced Engagement, or proceed directly to follow-up

4 weeks

Virtual engagement

Follow-up

Participants are monitored for treatment initiation, engagement, and alcohol consumption behaviors

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MI-CBT
• Portal Engagement
• Telephone Engagement

Trial Overview

The study tests new virtual care strategies like MI-CBT (a therapy approach), Telephone Engagement, and Portal Engagement to see if they help with managing health behaviors tied to alcohol use. It aims at setting goals and teaching skills through technology-driven programs.

How Is the Trial Designed?

Group I: Arm A Active Control 2 Interventions

First stage intervention: Telephone engagement Second stage intervention: Telehealth Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT program)

Group II: Arm B Active Control 1 Intervention

First stage intervention: Telephone engagement Second stage intervention: Enhanced Telephone engagement

Group III: Arm C Active Control 1 Intervention

First stage intervention: Telephone engagement Second stage intervention: Not Applicable (NA), proceed directly to follow up

Group IV: Arm D Active Control 1 Intervention

First stage intervention: Portal Engagement Second stage intervention: NA, proceed directly to follow up

Group V: Arm E Active Control 1 Intervention

First stage intervention: Portal Engagement Second stage intervention: Enhanced Portal Engagement

Group VI: Arm F Active Control 2 Interventions

First stage intervention: Portal Engagement Second stage intervention: Telehealth MI-CBT program

MI-CBT is already approved in United States, European Union, Canada for the following indications:

Approved in United States as MI-CBT for:

• Alcohol Use Disorder

Approved in European Union as MI-CBT for:

• Alcohol Dependence
• Substance Abuse

Approved in Canada as MI-CBT for:

• Alcohol Use Disorder
• Mental Health Disorders

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A survey of 127 active patients in alcohol treatment settings revealed mixed attitudes towards the use of medications like naltrexone and disulfiram for alcoholism, indicating a divide in acceptance of pharmacotherapy.

The willingness to consider medication as part of treatment was strongly linked to the belief that these medications would be beneficial, highlighting the importance of patient perceptions in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholic patients' experience and attitudes on pharmacotherapy for alcoholism. Swift, RM., Duncan, D., Nirenberg, T., et al.[2022]

In a study of 149 alcohol-dependent patients, those receiving broad-spectrum treatment (BST) combined with naltrexone had significantly more days of abstinence compared to those receiving motivational-enhancement therapy (MET) with naltrexone.

The effectiveness of BST was particularly pronounced in patients with supportive social networks, indicating that BST may provide a meaningful clinical advantage over MET when used alongside naltrexone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building better cognitive-behavioral therapy: is broad-spectrum treatment more effective than motivational-enhancement therapy for alcohol-dependent patients treated with naltrexone? Davidson, D., Gulliver, SB., Longabaugh, R., et al.[2019]

The AGATE intervention, which uses SMS text messaging to remind participants about their medication, is being tested in a randomized controlled trial with 105 treatment-seeking heavy drinkers over an eight-week period to see if it improves adherence to naltrexone, a medication for alcohol use disorders.

This study aims to evaluate the feasibility and effectiveness of mobile health technologies in enhancing medication adherence, which could lead to better treatment outcomes for individuals with alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial evaluating an mHealth system to monitor and enhance adherence to pharmacotherapy for alcohol use disorders. Stoner, SA., Hendershot, CS.[2021]

In a 12-week clinical trial with 202 alcohol-dependent patients, naltrexone significantly reduced the relapse rate to heavy drinking (7.9% for naltrexone vs. 18.8% for placebo), indicating its efficacy in treating alcoholism.

Naltrexone was well-tolerated with low rates of adverse events, such as abdominal pain and headache, and it did not negatively affect liver function or biochemical markers of heavy drinking, demonstrating its safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, placebo-controlled study of naltrexone in the treatment of alcohol-dependence disorder: results from a multicenter clinical trial. Guardia, J., Caso, C., Arias, F., et al.[2013]

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 systematic review of 49 trials found that only 14% of studies on naltrexone for alcohol dependence had high adherence assurance, which may explain the variability in treatment efficacy observed.

The study revealed a significant correlation between adherence levels and treatment outcomes, suggesting that improving adherence monitoring could enhance the effectiveness of naltrexone in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence monitoring in naltrexone pharmacotherapy trials: a systematic review. Swift, R., Oslin, DW., Alexander, M., et al.[2022]

Clients perceive motivational interviewing (MI) as a complex interaction that significantly influences their thoughts and feelings about alcohol abuse, highlighting the therapy's impact on personal change.

Key therapeutic elements identified by clients, such as a non-confrontational approach and the development of discrepancies between beliefs and behaviors, align with established MI principles and emphasize the importance of the therapist-client relationship in the effectiveness of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client experiences of motivational interviewing: An interpersonal process recall study. Jones, SA., Latchford, G., Tober, G.[2016]

In a study involving 105 participants in a cocaine detoxification program, those who received a brief motivational interviewing (MI) intervention showed improved use of behavioral coping strategies and had fewer cocaine-positive urine samples when starting primary treatment.

Participants with lower initial motivation who received MI were more likely to complete the detoxification program, suggesting that MI can enhance treatment engagement for individuals struggling with motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing with cocaine-dependent patients: a pilot study. Stotts, AL., Schmitz, JM., Rhoades, HM., et al.[2019]

Motivational interviewing (MI) is an effective approach for promoting intrinsic motivation for change in individuals with addictive behaviors and is now being applied to treat health-related behaviors in chronic diseases, including schizophrenia.

Available studies suggest that MI can improve medication adherence, reduce the frequency and severity of psychotic relapses, and enhance overall functioning in patients with schizophrenia, although more research is needed to fully establish its efficacy in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing : A possibility for doctor-patient communication in schizophrenia?] Reimer, J., Kuhn, J., Wietfeld, R., et al.[2020]

Motivational interviewing (MI) significantly improves medication adherence compared to control groups, with a relative risk of 1.17 and a standardized mean difference of 0.70, based on a systematic review of 17 randomized clinical trials.

Certain characteristics of MI delivery, such as telephonic format and fidelity-based feedback, were associated with better adherence outcomes, but results varied widely, indicating a need for further research to clarify these effects across diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing Improves Medication Adherence: a Systematic Review and Meta-analysis. Palacio, A., Garay, D., Langer, B., et al.[2022]

Mobile phone-based motivational interviewing (MI) significantly reduced alcohol use problems in adults, with an average improvement of nearly three points on the AUDIT-C scale compared to a waitlist control after one month.

The study found no significant difference in effectiveness between mobile MI and in-person MI at one month, suggesting that mobile MI can be a viable alternative for reaching patients in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of mobile phone motivational interviewing for alcohol use problems in Kenya. Harder, VS., Musau, AM., Musyimi, CW., et al.[2021]

A web-based program was developed to motivate individuals with drinking problems to seek treatment, targeting those who typically do not perceive a need for help.

After using the program, the percentage of participants expressing 'very interested' in traditional treatment increased from 19% to 28%, indicating the program's effectiveness in enhancing treatment motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways to change: the effect of a Web application on treatment interest. Lieberman, DZ., Massey, SH.[2016]

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]

A systematic review of 62 studies on remotely delivered interventions for alcohol and substance misuse found that many techniques, such as self-monitoring and reducing exposure to cues, showed promise in promoting behavior change.

While some interventions were deemed very promising, concerns about risk of bias and the potential for inflated effectiveness suggest that results should be interpreted cautiously.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and behaviour change technique analysis of remotely delivered alcohol and/or substance misuse interventions for adults. Howlett, N., García-Iglesias, J., Bontoft, C., et al.[2022]

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