AzTrials
AzTrials

Substance-Related DisordersNCT06208839

Mobile Technologies Extending Reach of Primary Care for Substance Use Disorders

A study testing SBIRT/eIntervention for those with moderate risk drug or alcohol use, SBIRT/eIntervention those assessed with high risk. and SBIRT/TAU for those with moderate risk drug or alcohol use in people with Substance-Related Disorders, run by Chess Mobile Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance-Related Disorders
What is being tested?
SBIRT/eIntervention for those with moderate risk drug or alcohol use, SBIRT/eIntervention those assessed with high risk. and SBIRT/TAU for those with moderate risk drug or alcohol use
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
1 siteUnited States
Study dates
25 Mar 2024to 26 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adults aged 18 or over
  • receiving primary care at Western Michigan
  • identified as having a substance-specific NIDA Modified Assist score of 27 or greater.

Who cannot join

  • non-English speaking
  • cannot read at a 3rd grade level,
  • have current participation in addiction treatment
  • determined to be psychiatrically or medically unstable such that completion of the trial is unlikely.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • WMed Health Family Medicine

    Kalamazoo, Michigan, 49008

Other trials in United States

About this study

Official title: Mobile Technologies Extending Reach of Primary Care for Substance Use

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.

Read the detailed description

The investigators will recruit and randomize 200 individuals screening positive on the NIDA Quick Screen.

All participants will receive SBIRT as currently implemented at Western Michigan and as described above. Adult patients would be asked prior to appointments at Western Michigan, either in-person when in a waiting room and/or via email for virtual appointments if they'd would be willing to answer a brief, anonymous online survey regarding their substance use as part of a research study. Upon completing the survey, the results of the survey would be displayed for the patient to see. If the patient's answers to the screening tool indicate their use may be risky or indicates a serious problem regarding assessment, then they would be asked if they would consider participating in a research study (the investigators would provide an online description of the requirements of the study and the payments for participation). If they click through as being interested, the investigators will display more detail about the research study, explain that they will need to review and sign a consent form, and would be required to speak with a research assistant in the coming days. The investigators would present them an electronic consent form and require them to scroll through and, if necessary, could ask them a question or two to confirm their understanding, before allowing them to electronically sign the consent. The investigators would advise them that their participation will not be anonymous. If the patient consents, then the investigators would have them to complete the longer NIDA ASSIST or AUDIT screening tool. If the patient's answers indicate a risk score in the low-risk range for either alcohol or illicit drugs, the investigators will exclude them from continuing in the study.

If the patient's answers indicate a risk score in the moderate to high range, then they would be randomized to the intervention group or the control group. As part of the randomization process, the SBIRT/TAU and the SBIRT/eIntervention groups will have two sub-groups each: (1) those with moderate risk drug or alcohol use and those at high risk or with SUD as measured by the ASSIST and the AUDIT assessment tools). Thus, participants will have been randomized into four cohorts of about 50 subjects each.

If the patient is randomized to the intervention group, then they would be presented a set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, they will receive a 'brief intervention' based on the "Drinker's Checkup" licensed by CHESS Health from San Diego State University.

Whether in the intervention group or the control group, they would be recommended for a referral to treatment. If they're already in SUD treatment, then will exclude them from continuing in the study. If the patient is randomized to the intervention group, then in addition to the referral, they would be given use of the Envoy App with referral details and a TBD set of digital interventions for them to access then as well as to have access to in the coming weeks/months. If the patient is randomized to the control group, then they would only get the referral to treatment plus a basic version of the app that consists solely of the survey engine used for primary data collection. The investigators will conduct a 3-month randomized clinical trial, with a 6-month follow-up.

Being tested
SBIRT/eIntervention for those with moderate risk drug or alcohol use, SBIRT/eIntervention those assessed with high risk., SBIRT/TAU for those with moderate risk drug or alcohol use, SBIRT/TAU for those assessed with high risk.
Keywords
Substance Use Disorder, Screening, Brief Intervention, Referral, and Treatment
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBIRT/eIntervention for those with moderate risk drug or alcohol useDevice

    The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities:

    • Online view of the referrals made for them e.g. to healthcare provider
    • Secure messaging with the referring provider
    • Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider,
    • Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery,
    • Capture structured feedback from the patient

    The patient may access more functionality within the Connections App for those who wish to modify behavior using eTherapy and eRecovery. eRecovery includes ecological momentary assessments (EMA) selected by the provider.

  • SBIRT/eIntervention those assessed with high risk.Device

    The Connections App is available on iOS or Android and will be offered to the patient during the referral process and contains the following functionalities:

    • Online view of the referrals made for them e.g. to healthcare provider
    • Secure messaging with the referring provider
    • Secure messaging with the destination provider(s) to support them to adhere to the referral, and/or the patient can seek assistance with the destination provider,
    • Informative multimedia content filtered from a library to fit the patient including testimonial content from peers thus showing the patient that others like them have shared their addiction experience and successfully received treatment and achieved recovery,
    • Capture structured feedback from the patient

    The patient may access more functionality within the Connections App for those who wish to modify behavior using eTherapy and eRecovery. eRecovery includes ecological momentary assessments (EMA) selected by the provider.

  • SBIRT/TAU for those with moderate risk drug or alcohol useOther

    Also called Treatment as usual group[

    Treatment as usual

  • SBIRT/TAU for those assessed with high risk.Other

    Also called High risk treatment as usual

    Treatment as usual for high risk group

Study groups in NCT06208839
Study groupRoleWhat they receive
SBIRT/TAU for those with moderate risk drug or alcohol useActive comparatorThis moderate risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.
Receives: Other: SBIRT/TAU for those with moderate risk drug or alcohol use
SBIRT/eIntervention for those with moderate risk drug or alcohol useExperimentalSubjects 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.
Receives: Device: SBIRT/eIntervention for those with moderate risk drug or alcohol use
SBIRT/TAU for those assessed with high risk.Active comparatorThis high risk group will receive the standard Screening and Brief Intervention Treatment (SBIRT) along with Treatment as Usual (TAU) at the clinic.
Receives: Other: SBIRT/TAU for those assessed with high risk.
SBIRT/eIntervention those assessed with high risk.ExperimentalSubjects 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.
Receives: Device: SBIRT/eIntervention those assessed with high risk.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NIDA Quick Screen

    The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used.

    Measured: Screening

  2. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed for the World Health Organization (WHO) by an international group of researchers and clinicians as a technical tool to assist with early identification of substance use related health risks and substance use disorders in primary health care, general medical care and other settings

    Measured: Screening, 3-month, and 6-month

  3. The Alcohol Use Disorders Identification Test (AUDIT)

    The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviors, and alcohol-related problems. We will also administer the AUDIT for patients who screen positive for alcohol via the NIDA Quick Screen.

    Measured: Screening, 3-month, and 6-month

  4. Demographics

    Participant Age

    Measured: Baseline

  5. Demographics

    Participant Race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White)

    Measured: Baseline

  6. Demographics

    Participant Biological Sex (Male/Female)

    Measured: Baseline

  7. Demographics

    Participant Ethnicity (Hispanic/Latino vs. non-Hispanic/Latino)

    Measured: Baseline

  8. TimeLine Follow-back method

    Self-reports are collected using the TimeLine Follow-back method, a widely used and well-validated technique for collecting information on all types of substance use on a day-by day basis for the full period of each participants trial involvement (covering the 3 months prior to baseline through the end of the follow-up).

    Measured: Baseline, 3-month, and 6-month

  9. Healthcare utilization

    Self reported treatment utilization (including emergency department visits, hospitalization, specialty care visits, attendance at self-help meetings) in all conditions.

    Measured: Baseline, 3-month, and 6-month

  10. Contemplation ladder

    To assess patient motivation

    Measured: Baseline, 3-month, and 6-month

  11. Satisfaction survey

    Evaluate patients' satisfaction with treatment and interventions

    Measured: 3-month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start25 Mar 2024
  3. Primary completion26 Feb 2026
  4. Study completion26 Feb 2026

Why it stopped: Recruitment goals not met.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208839
Sponsor's protocol ID
2023-SBIR-ChessHealth
Other IDs
1R44DA050214
Status last verified
Feb 2026
First submitted
14 Dec 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing SBIRT/eIntervention for those with moderate risk drug or alcohol use, SBIRT/eIntervention those assessed with high risk. and SBIRT/TAU for those with moderate risk drug or alcohol use in people with Substance-Related Disorders, run by Chess Mobile Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment goals not met.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NIDA Quick Screen (time frame: Screening). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in