Smartphone App + Medications for Alcoholism

Recruiting at 14 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

Trial Summary

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 data supports the effectiveness of the Stand Down app treatment for alcoholism?

Research shows that smartphone apps can help reduce alcohol consumption when used alongside standard treatments. Apps that offer information, monitoring, and motivational tools have been found to enhance the effectiveness of addiction treatments. ^{1 2 3 4 5}

Is the Smartphone App + Medications for Alcoholism treatment safe for humans?

The research on smartphone apps for alcohol use disorder suggests they are generally safe, but more studies are needed to confirm their safety and effectiveness. No specific safety concerns have been reported in the studies reviewed. ^{3 4 5 6 7}

How is the Stand Down app treatment for alcoholism different from other treatments?

The Stand Down app treatment is unique because it combines a smartphone app with medications to help manage alcoholism, offering a novel approach that integrates technology with traditional pharmacotherapy, unlike standard treatments that typically focus on medication or counseling alone. ^{8 9 10 11 12}

What is the purpose of this trial?

One in 10 Veterans have an alcohol use disorder. However, few Veterans receive evidenced-based psychosocial interventions or medications to treat alcohol use disorder. Barriers to receiving these treatments include long wait times, stigma, and long distances from treatment facilities. Even fewer Veterans receive psychosocial and medication interventions together, despite clinical practice guidelines recommending both and evidence of better outcomes. Expanding access to these treatments in primary care is a VA priority but delivering psychosocial interventions is difficult in this setting, and medication is often the only option. Smartphone apps that deliver alcohol interventions may improve drinking outcomes and ensure Veterans can receive both treatments in primary care. This study will determine whether medications and an app for alcohol use problems offered to Veterans in primary care results in improved drinking outcomes, compared to Veterans receiving medications only. Study data will inform how to spread the app across the VA nationally.

Research Team

Eric J. Hawkins, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. [2022]

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

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Smartphone apps for managing alcohol consumption: a literature review. [2021]

6. United States 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. [2022]

7. England 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. [2022]

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

Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery. [2023]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Effects of acamprosate on sleep during alcohol withdrawal: A double-blind placebo-controlled polysomnographic study in alcohol-dependent subjects. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for alcohol dependence: status of current treatments. [2018]

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

Acamprosate: a review of its use in the maintenance of abstinence in patients with alcohol dependence. [2018]