Smartphone App + Medications for Alcoholism

Recruiting at 19 trial locations

Overseen By Anissa N Danner, MSW BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: MAUD

Disqualifiers: Recent SUD treatment, Pregnancy, Severe psychiatric symptoms, others

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

Compensation: Varies

Number of Visits: 15

Duration: 6 months

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a smartphone app combined with medications can help Veterans with alcohol use disorder (AUD) reduce their drinking. The study compares outcomes between Veterans using both the Stand Down mobile app and medications and those using medications alone. Veterans who might be a good fit have been diagnosed with AUD, experience heavy drinking days, and are enrolled in VA primary care, planning to start medication. The trial aims to make effective treatments for alcohol problems more accessible to Veterans through their phones. As an unphased trial, it offers Veterans the opportunity to explore innovative ways to manage alcohol use disorder with accessible technology.

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 adding a smartphone app to existing medication treatments for alcohol use disorder.

What prior data suggests that the Stand Down mobile app is safe for Veterans?

Research shows that the Stand Down mobile app is generally safe for users and helps manage alcohol use. Previous studies have demonstrated that the app effectively reduces drinking among Veterans without major safety concerns.

The medications used in this trial, including naltrexone, disulfiram, acamprosate, and topiramate, are already approved or recommended for treating alcohol use disorder. These medications are well-known and have a history of safe use.

Overall, both the app and the medications are considered safe for participants, with no major safety issues reported for either treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stand Down mobile app because it offers a unique, tech-driven approach to tackling alcoholism. Unlike traditional medications like naltrexone, disulfiram, and acamprosate, which are part of the standard care, this app provides a digital support tool that can be accessed anytime, anywhere. This flexibility and accessibility add a new layer of support, potentially enhancing the effectiveness of existing medication-assisted treatments. By integrating technology with standard care, the Stand Down app aims to offer a more holistic and convenient solution for individuals struggling with alcohol use disorder.

What evidence suggests that the Stand Down app combined with medications could be effective for alcohol use disorder?

Research has shown that the Stand Down app can significantly help Veterans improve their drinking habits. In this trial, participants in the Combined MAUD+SD-App arm will access the Stand Down app alongside standard medication-assisted treatment. Studies where Veterans used the app with peer support found that many could better manage their drinking. The app provides tools to control alcohol use, allowing Veterans to access support quickly without long waits or travel. Using the app with medications like naltrexone or disulfiram may lead to even better results. Evidence suggests that this combined approach could be more effective than medication alone. ^{1 2 4 6 7}

Who Is on the Research Team?

Eric J. Hawkins, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

This trial is for Veterans with alcohol use disorder who face challenges like long wait times, stigma, or distance from treatment facilities. It's designed to see if combining a smartphone app with standard care improves management of heavy drinking in primary care settings.

Inclusion Criteria

Android or iPhone smartphone owners

I am starting a new medication as prescribed by my doctor.

Willing to be randomized

Exclusion Criteria

Plans to be or are pregnant

Past 30-day participation in VA or non-VA SUD treatment

I do not have severe mental health issues that would stop me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MAUD and access to the Stand Down app for alcohol use disorder management

6 months

Baseline, 3-month, 6-month visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

12-month visit

What Are the Treatments Tested in This Trial?

Interventions

• Stand Down mobile app

Trial Overview The study is testing whether the 'Stand Down' mobile app combined with standard medication treatments can better help manage heavy drinking among Veterans compared to medications alone. The goal is to improve access and outcomes in primary care.

How Is the Trial Designed?

Group I: Combined MAUD+SD-App Experimental Treatment 1 Intervention

In addition to standard MAUD care, participants assigned to the MAUD+SD-App condition will receive access to the Stand Down app at randomization.

Group II: Standard Care Active Control 1 Intervention

Participants assigned to the standard care condition will receive standard MAUD care delivered by their CPSs and will not receive access to SD-App. Three medications, naltrexone, disulfiram, and acamprosate, have been approved by the Federal Drug Administration and topiramate has been recommended by the VA/DoD clinical practice guidelines for SUD. MAUD includes these four medications. All medication decisions will be between the CPS and the Veteran and not influenced by study participation.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

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]

Mobile phone applications, when used alongside standard addiction treatments, can enhance the effectiveness of these treatments by providing tools for information, monitoring, motivation, and relapse prevention.

Most studies reviewed indicated that patients using these applications experienced a greater reduction in substance consumption compared to those receiving standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. Penzenstadler, L., Thorens, G., Bachmann, S.[2022]

A review of 21 studies on 19 unique smartphone apps aimed at reducing alcohol consumption found that while apps for adults show some promise, the evidence is still mixed and inconclusive.

Only four out of eight evaluated apps available in commercial app stores have demonstrated effectiveness in helping users reduce their alcohol consumption, highlighting a gap between research and practical availability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for managing alcohol consumption: a literature review. Colbert, S., Thornton, L., Richmond, R.[2021]

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

The Drinkaware app, used by over 119,000 people in a 13-month study, effectively supports behavior change in motivated users, leading to reduced alcohol consumption, especially within the first week of use.

Despite its effectiveness, the app experienced high user drop-off after one week, indicating a need for greater personalization and tailored features to enhance long-term engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile health application to reduce alcohol consumption: a mixed-methods evaluation of the drinkaware track & calculate units application. Attwood, S., Parke, H., Larsen, J., et al.[2022]

The SIDEAL mobile app was well-accepted by 24 adult patients with alcohol dependence, showing high usage rates (80% of study days) and high satisfaction levels, particularly with its self-register and feedback features.

Participants experienced significant reductions in alcohol consumption over 6 weeks, with binge drinking days decreasing from an average of 25 to 5.8 and mean daily consumption dropping from 6.5 to 1.9 standard units, indicating the app's potential efficacy in managing alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Barrio, P., Ortega, L., López, H., et al.[2018]

In a study of 24 alcohol-dependent men, acamprosate significantly improved sleep quality by reducing wake time after sleep onset and increasing the latency to REM sleep compared to a placebo.

Acamprosate was well tolerated and effectively mitigated sleep disturbances associated with alcohol withdrawal, suggesting it could be beneficial in the recovery process for individuals with alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of acamprosate on sleep during alcohol withdrawal: A double-blind placebo-controlled polysomnographic study in alcohol-dependent subjects. Staner, L., Boeijinga, P., Danel, T., et al.[2018]

Acamprosate is effective in maintaining abstinence in detoxified alcohol-dependent patients, showing better efficacy than placebo in several double-blind trials lasting up to 12 months, regardless of disease severity or psychosocial support.

The drug likely works by modulating the glutamatergic system to restore balance disrupted by alcohol use, and it is well tolerated, making it a promising option for patients, especially those with liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acamprosate: a review of its use in the maintenance of abstinence in patients with alcohol dependence. Scott, LJ., Figgitt, DP., Keam, SJ., et al.[2018]

A content analysis of 266 smartphone apps for managing alcohol use revealed that these apps have been downloaded over 2.7 million times, indicating a significant public health reach.

While 60% of the apps provided some level of tailored feedback, the overall extent of this tailoring was limited, suggesting that there is room for improvement in how these apps meet individual user needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

There is an app for that - Or is there? A content analysis of publicly available smartphone apps for managing alcohol use. Hoeppner, BB., Schick, MR., Kelly, LM., et al.[2022]

Currently approved medications for alcohol dependence, such as acamprosate, disulfiram, and naltrexone, have only modest efficacy, indicating a need for more effective treatment options.

Emerging candidates like baclofen and topiramate show promise in clinical trials, suggesting that new approaches may enhance treatment outcomes for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for alcohol dependence: status of current treatments. Franck, J., Jayaram-Lindström, N.[2018]

Insomnia associated with alcohol cessation (IAAC) is a significant issue for individuals with alcohol use disorder (AUD), often persisting for weeks to years after stopping alcohol use, highlighting a critical unmet need for effective treatments.

A review of 18 studies, including 15 randomized controlled trials, found that while various classes of medications (like antidepressants and anticonvulsants) have been tested for treating sleep disturbances in abstinent AUD patients, none are currently FDA-approved for IAAC, indicating a need for further research on their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery. Roehrs, TA., Auciello, J., Tseng, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10106019/

Stand Down–Think Before You Drink - PubMed Central - NIH ... Stand Down app, given findings that poor patient engagement severely limits the potential effectiveness of mobile apps for alcohol use.

2. hsrd.research.va.gov hsrd.research.va.gov/publications/forum/spring20/default.cfm?ForumMenu=spring20-innovation

Stand Down: Think Before You Drink—A Mobile App for ... Mobile apps can bypass these barriers; however, the evidence base supporting the efficacy of apps for reducing hazardous drinking in Veterans is limited.

3. clinicaltrial.be clinicaltrial.be/en/details/15818?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Stand Down-Think Before You Drink: An RCT of a Mobile App... The intervention ("Peer-Supported [PS]-Stand Down") was highly acceptable to patients, and patients reported significant improvements in drinking outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06303778

Combining a Smartphone App With Medications to ... This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05473598/stand-down-think-before-you-drink-an-rct-of-a-mobile-app-for-hazardous-drinking-with-peer-phone-support?page=4&id=9&slug=alcohol-dependence

Stand Down-Think Before You Drink: An RCT of a Mobile App for ... The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary care patients who ...

6. trialx.com trialx.com/clinical-trials/listings/247938/stand-down-think-before-you-drink-an-rct-of-a-mobile-app-for-hazardous-drinking-with-peer-phone-support/

An RCT of a Mobile App for Hazardous Drinking With Peer ... The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary ...

7. withpower.com withpower.com/trial/phase-alcoholism-11-2022-a13b3

Stand Down App + Peer Support for Alcoholism The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary care patients who ...