Mobile Technologies for Substance Use Disorders

Overseen By Hans Morefield

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Chess Mobile Health

Disqualifiers: Non-English, Illiterate, Addiction treatment, Unstable, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate efficacy of our enhanced version of the CHESS Health eIntervention in a clinical setting for those with moderate risk drug or alcohol use and those at high risk or with Substance Use Disorder (SUD) as measured by the ASSIST and the AUDIT assessment tools. The clinical trial is designed to determine whether SBIRT/eIntervention is significantly more effective than SBIRT/Treatment as usual (TAU) as delivered in a primary care setting. While it is not feasible or practical to individually test all components and features of the planned eIntervention, this design will permit testing of efficacy for reduction of substance use in both risk groups and increased enrollment in treatment for the high risk/SUD group in the SBIRT/eIntervention cohorts compared to the SBIRT/TAU cohorts. Note that the investigators are not including a screening/assessment only or other control condition, as the purpose of this clinical trial is not to test the efficacy of SBIRT itself, but rather to test whether SBIRT/eIntervention improves outcomes and successful referral relative to SBIRT/TAU delivery alone.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for substance use disorders?

Research shows that mobile and web-based technologies, like A-CHESS and E-SBIRT, can help people with substance use disorders by providing ongoing support and resources, which may reduce risky behaviors and prevent relapse. These tools have been used successfully to support recovery from alcohol dependence and other substance use issues. ^{1 2 3 4 5}

Is the use of mobile technologies for substance use disorders safe for humans?

The studies reviewed focus on the effectiveness of SBIRT (Screening, Brief Intervention, and Referral to Treatment) and its electronic versions for addressing substance use issues, but they do not specifically report any safety concerns related to these interventions. Generally, these interventions are considered safe as they involve non-invasive methods like computer-assisted screenings and brief interventions. ^{2 5 6 7 8}

How is the SBIRT/eIntervention treatment unique for substance use disorders?

SBIRT/eIntervention, including A-CHESS, is unique because it uses mobile technology to provide ongoing support and resources for people recovering from substance use disorders, helping to prevent relapse by offering timely emotional and practical assistance. This approach is novel as it extends care beyond traditional treatment settings, making it accessible and individualized, which is particularly important for managing the chronic nature of addiction. ^{2 3 9 10 11}

Research Team

Hans Morefield

Principal Investigator

CHESS Health

Eligibility Criteria

This trial is for adults over 18 receiving primary care in Western Michigan who have a substance-specific NIDA Modified Assist score of 27 or greater, indicating moderate to high risk drug or alcohol use.

Inclusion Criteria

I am 18 years old or older.

Receiving primary care at Western Michigan

Identified as having a substance-specific NIDA Modified Assist score of 27 or greater.

Exclusion Criteria

Non-English speaking

Cannot read at a 3rd grade level

Have current participation in addiction treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Randomization and Intervention

Participants are randomized into intervention or control groups and receive either the eIntervention app or Treatment as Usual (TAU)

3 months

Ongoing access to digital interventions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including satisfaction surveys and healthcare utilization assessments

6 months

2 visits (in-person or virtual)

Treatment Details

Interventions

• SBIRT/eIntervention
• SBIRT/TAU

Trial Overview The study tests the effectiveness of an enhanced CHESS Health eIntervention versus standard treatment (SBIRT/TAU) in reducing substance use and improving treatment enrollment among those at moderate to high risk for Substance Use Disorders.

Participant Groups

Group I: SBIRT/eIntervention those assessed with high risk. Experimental Treatment 1 Intervention

Subjects assigned to this condition will be instructed by the research assistant in how to download and use the eIntervention app, which they will be free to use as they like for the duration of the study. The app will contain a personalized suite of programs and activities. Unlike the TAU condition, the patient's referral to treatment would be managed through eIntervention. For example, the app will show the patient their referral details (if a referral to treatment was made), including details on the provider, referred services, and contact information, and will offer them videos of peers and professionals educating them on addiction, treatment, and sharing personal stories of recovery.

Group II: SBIRT/eIntervention for those with moderate risk drug or alcohol use Experimental Treatment 1 Intervention

Subjects assigned to this condition will be instructed by the research assistant in how to download and use the eIntervention app, which they will be free to use as they like for the duration of the study. The app will contain a personalized suite of programs and activities. Unlike the TAU condition, the patient's referral to treatment would be managed through eIntervention. For example, the app will show the patient their referral details (if a referral to treatment was made), including details on the provider, referred services, and contact information, and will offer them videos of peers and professionals educating them on addiction, treatment, and sharing personal stories of recovery.

Group III: SBIRT/TAU for those with moderate risk drug or alcohol use Active Control 1 Intervention

This moderate risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.

Group IV: SBIRT/TAU for those assessed with high risk. Active Control 1 Intervention

This high risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.

SBIRT/eIntervention is already approved in United States for the following indications:

Approved in United States as CHESS Health eIntervention for:

• Substance Use Disorder (SUD)
• Alcohol Use Disorder

Who Is Running the Clinical Trial?

Chess Mobile Health

Lead Sponsor

Trials

1

Recruited

200+

Western Michigan University

Collaborator

Trials

18

Recruited

2,900+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Technology, including the Internet and mobile phones, has significant potential to improve the assessment, prevention, and treatment of substance use disorders, suggesting new models of behavioral health care.

The article reviews existing empirical support for technology-based interventions in addiction treatment and highlights the need for further research to optimize their effectiveness and impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging technology to enhance addiction treatment and recovery. Marsch, LA.[2021]

The Health Evaluation and Referral Assistant (HERA) system improved initial contact with alcohol treatment providers and increased treatment initiation among participants who accepted a faxed referral, but did not significantly change risky alcohol use behavior over a 3-month follow-up period.

Despite its potential, the HERA's effectiveness was limited by factors such as lack of clinical staff support, the low intensity of the intervention, and barriers to patient follow-through, indicating that additional support may be needed for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients. Haskins, BL., Davis-Martin, R., Abar, B., et al.[2023]

A-CHESS, a smartphone-based system, was used by 349 individuals with alcohol dependence after leaving treatment, showing high engagement with 94% using it in the first week and 80% at week 16, indicating its potential for ongoing support in preventing relapse.

The study suggests that A-CHESS can effectively extend care for individuals with alcohol dependence, as those with co-occurring drug dependence and mental health issues also utilized the app, although further research is needed to confirm its impact on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Patients Recovering From Alcoholism Use a Smartphone Intervention. McTavish, FM., Chih, MY., Shah, D., et al.[2022]

Out of 1973 participants offered the Connections app for substance use disorder, 40% downloaded it, and those who used the app showed improvements in their addiction-related behaviors over time, as measured by the Brief Addiction Monitor (BAM).

Participants referred by justice-related agencies preferred telehealth support from social workers, while self-referred individuals benefited equally from using the app alone or with recovery support services, indicating that self-motivated users may gain more from digital therapeutic tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The adoption and sustainability of digital therapeutics in justice systems: A pilot feasibility study. Wilde, JA., Zawislak, K., Sawyer-Morris, G., et al.[2023]

The E-SBIRT program, a web-based intervention for substance use, is being tested in a randomized controlled trial involving 240 participants across four primary healthcare institutions in China, aiming to assess its effectiveness compared to standard pamphlet information.

If proven effective, E-SBIRT could provide a scalable and cost-effective solution for early intervention in individuals at moderate risk of substance use, potentially reducing harmful consequences for both individuals and society.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of E-SBIRT intervention in community healthcare institution in China: study proposal for a randomised controlled trial. Fu, R., Yuan, C., Sun, W., et al.[2022]

In a psychiatric inpatient unit, 59% of all admissions were offered the Screening, Brief Intervention, and Referral to Treatment (SBIRT), demonstrating its integration into routine care.

The implementation of SBIRT led to a significant reduction in readmission rates, with an 18.3% decrease in the first two months and a remarkable 67.5% decrease during the 16-31 days post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of Nurse-Administered Screening, Brief Intervention, and Referral to Treatment in a Brief Psychiatric Inpatient Unit. Kracher, S., Bayette, L., Young, D., et al.[2023]

The review analyzed 30 studies over 14 years that explored non-face-to-face (nFtF) strategies in emergency department-based screening and intervention for high-risk alcohol use, highlighting a variety of methods like computerized screening and text message interventions.

Results were mixed regarding the effectiveness of these nFtF interventions, indicating a need for further research to address specific populations and improve methodological standards in ED-SBIRT studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of non-face-to-face modalities for emergency department screening, brief intervention, and referral to treatment (ED-SBIRT) for high-risk alcohol use: A scoping review. Biroscak, BJ., Pantalon, MV., Dziura, JD., et al.[2021]

This study will test a nurse-led toolkit designed to enhance the implementation of Screening, Brief Intervention, and Referral to Treatment (SBIRT) in 14 acute care hospitals, aiming to improve the recognition and treatment of risky substance use among patients.

The effectiveness of the SBIRT toolkit will be evaluated by analyzing documentation of its delivery in electronic medical records over 12 months, with the goal of improving clinician engagement in addressing substance use issues and ultimately reducing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach. Newhouse, R., Janney, M., Gilbert, A., et al.[2020]

A survey of 139 participants showed strong interest in using a mobile health application that monitors blood alcohol concentration (BAC) through gait analysis, indicating potential for reducing risky drinking behaviors.

Participants expressed a desire for control over app features, with adults preferring the option to disable BAC monitoring, while females favored mandatory notifications and safety features, highlighting the importance of user preferences in app design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. Borges, A., Caviness, C., Abrantes, AM., et al.[2023]

Mobile technology-based interventions show promise in helping adults reduce or cease harmful alcohol use, with eight studies indicating positive effects despite variations in design and target populations.

Further research is needed to determine the optimal duration and frequency of these interventions, as well as to compare their effectiveness with traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. Fowler, LA., Holt, SL., Joshi, D.[2022]

Wearable sensors are the most commonly used wireless technologies for treating substance use disorders, showing promise in reducing heavy use, preventing relapse, and monitoring for overdose.

These technologies offer significant advantages over traditional therapies, such as increased accessibility and continuous monitoring, making them valuable additions to comprehensive treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable and Wireless mHealth Technologies for Substance Use Disorder. Goldfine, C., Lai, JT., Lucey, E., et al.[2022]

References

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

Leveraging technology to enhance addiction treatment and recovery. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Health Evaluation and Referral Assistant: A Randomized Controlled Trial of a Web-Based Screening, Brief Intervention, and Referral to Treatment System to Reduce Risky Alcohol Use Among Emergency Department Patients. [2023]

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

How Patients Recovering From Alcoholism Use a Smartphone Intervention. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The adoption and sustainability of digital therapeutics in justice systems: A pilot feasibility study. [2023]

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

Effectiveness of E-SBIRT intervention in community healthcare institution in China: study proposal for a randomised controlled trial. [2022]

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

Utilization of Nurse-Administered Screening, Brief Intervention, and Referral to Treatment in a Brief Psychiatric Inpatient Unit. [2023]

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

Use of non-face-to-face modalities for emergency department screening, brief intervention, and referral to treatment (ED-SBIRT) for high-risk alcohol use: A scoping review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Study protocol testing toolkit versus usual care for implementation of screening, brief intervention, referral to treatment in hospitals: a phased cluster randomized approach. [2020]

9. China pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. [2023]

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

Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable and Wireless mHealth Technologies for Substance Use Disorder. [2022]