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mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care
NCT04935606 · View on ClinicalTrials.gov ↗
Study Summary
The QUIT-Mobile study proposes to use mobile phone self-monitoring and feedback to enhance and sustain over 12-months the impacts of the Quit Using Drugs Intervention Trial (QUIT), an effective screening and brief intervention (SBI) previously successful in reducing risky drug use (i.e., moderate use) in low-income, diverse patients over a 3-month follow up. The investigators will conduct the QUIT-Mobile study for patients who receive care in clinics of federally qualified health centers (FQHC) in Southern California over 12-months follow up. The study is an Effectiveness-Implementation Hybrid Type 1 design consisting of a single-blind, 3-arm, RCT with adult, mostly Latino FQHC primary care patients with risky drug use (ASSIST score 4-26), randomized to 3 conditions (n=200/arm, n=600 total): 1) QUIT-Mobile; 2) standard QUIT; 3) Usual Care. Qualitative data on implementation facilitators and barriers will inform future scale-up and sustainability, in addition to cost data analyses. The aims are to examine effectiveness in reducing risky drug use and cost-effectiveness comparing the three arms over 3-, 6- and 12-months. Drug use measures include self-reports for past 30-days and urine drug screen validation for underreporting (acknowledging that people with moderate risk drug use have sporadic drug use patterns requiring longer self-report recalls for drug use that urine screens may not detect). The 3-arm study enables testing of the independent and synergistic effects of QUIT-Mobile compared to QUIT and both to Usual Care. The 12-month timeline reflects annual primary care visits when screening and brief intervention would be repeated routinely. The QUIT intervention contains 3 primary components: 1) patient screening with the WHO ASSIST, 2) brief clinician advice (\<3 minutes) including opioid overdose prevention education, and 3) 2- and 6-week telephone drug-use health coaching sessions utilizing motivational interviewing and cognitive behavioral techniques, del
Conditions Studied
Interventions
- BEHAVIORAL Usual Care
- BEHAVIORAL QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks)
- BEHAVIORAL QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months)
Study Locations (5)
California
- The Children's Clinic (TCC) Family Health — Long Beach
- South Central Family Health Clinic — Los Angeles
- Wesley Health Centers — Los Angeles
- Saban Community Clinic — Los Angeles
- UMMA Community Clinic — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04935606
The ClinicalTrials.gov registry entry for NCT04935606 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 458 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Drug Use appearing as the primary indexed condition, and to 3 interventions — of which Usual Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04935606 reports 5 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04935606 about?
NCT04935606 is a clinical study titled "mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care". The QUIT-Mobile study proposes to use mobile phone self-monitoring and feedback to enhance and sustain over 12-months the impacts of the Quit Using Drugs Intervention Trial (QUIT), an effective screening and brief intervention (SBI) previously successful in reducing risky drug use (i.e., moderate us...
What is the current status of trial NCT04935606?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 458 participants. The study started on 2021-06-01. Estimated completion is 2026-03-31.
What conditions does trial NCT04935606 study?
This clinical trial studies the following conditions: Drug Use. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04935606?
The interventions under investigation include: Usual Care (BEHAVIORAL), QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks) (BEHAVIORAL), QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04935606?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04935606 being conducted?
This trial has 5 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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