Substance-Related Disorders Clinical Trial
Official title:
1R44DA050214 - 01 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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | April 2027 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chess Mobile Health | National Institute on Drug Abuse (NIDA), Western Michigan University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Demographics | Participant Age | Baseline | |
Primary | Demographics | Participant Race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White) | Baseline | |
Primary | Demographics | Participant Biological Sex (Male/Female) | Baseline | |
Primary | Demographics | Participant Ethnicity (Hispanic/Latino vs. non-Hispanic/Latino) | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | Contemplation ladder | To assess patient motivation | Baseline, 3-month, and 6-month | |
Primary | Satisfaction survey | Evaluate patients' satisfaction with treatment and interventions | 3-month, 6 month |
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