NCT06208839

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

December 14, 2023

Last Update Submit

February 26, 2026

Conditions

Substance-Related Disorders

Keywords

Substance Use DisorderScreening, Brief Intervention, Referral, and Treatment

Outcome Measures

Primary Outcomes (11)

  • 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.

    Screening

  • 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

    Screening, 3-month, and 6-month

  • 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.

    Screening, 3-month, and 6-month

  • Demographics

    Participant Age

    Baseline

  • Demographics

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

    Baseline

  • Demographics

    Participant Biological Sex (Male/Female)

    Baseline

  • Demographics

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

    Baseline

  • 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).

    Baseline, 3-month, and 6-month

  • Healthcare utilization

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

    Baseline, 3-month, and 6-month

  • Contemplation ladder

    To assess patient motivation

    Baseline, 3-month, and 6-month

  • Satisfaction survey

    Evaluate patients' satisfaction with treatment and interventions

    3-month, 6 month

Study Arms (4)

SBIRT/TAU for those with moderate risk drug or alcohol use

ACTIVE COMPARATOR

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

Other: SBIRT/TAU for those with moderate risk drug or alcohol use

SBIRT/eIntervention for those with moderate risk drug or alcohol use

EXPERIMENTAL

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.

Device: SBIRT/eIntervention for those with moderate risk drug or alcohol use

SBIRT/TAU for those assessed with high risk.

ACTIVE COMPARATOR

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

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

SBIRT/eIntervention those assessed with high risk.

EXPERIMENTAL

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.

Device: SBIRT/eIntervention those assessed with high risk.

Interventions

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/eIntervention those assessed with high risk.
SBIRT/TAU for those with moderate risk drug or alcohol useOTHER

Treatment as usual

Also known as: Treatment as usual group[
SBIRT/TAU for those with moderate risk drug or alcohol use
SBIRT/TAU for those assessed with high risk.OTHER

Treatment as usual for high risk group

Also known as: High risk treatment as usual
SBIRT/TAU for those assessed with high risk.
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 for those with moderate risk drug or alcohol use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WMed Health Family Medicine

Kalamazoo, Michigan, 49008, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

EthanolTherapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Hans Morefield

    CHESS Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 17, 2024

Study Start

March 25, 2024

Primary Completion

February 26, 2026

Study Completion

February 26, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations

US(1)