Using mobile phones to help reduce drug use in primary care patients

MHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care

This study is testing whether a mobile phone program can help primary care patients reduce their drug use more effectively than standard care or usual treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 5 sites (Long Beach, California and 4 other locations)
• Trial ID: NCT04935606 on ClinicalTrials.gov

What this trial studies

The QUIT-Mobile initiative aims to enhance and sustain reductions in risky drug use among primary care patients through a mobile phone self-monitoring and feedback system. This study builds on the successful Quit Using Drugs Intervention Trial (QUIT) by integrating mobile technology to support patients over a 12-month period. Participants will be randomized into three groups: QUIT-Mobile, standard QUIT, and Usual Care, with qualitative data collected to understand implementation challenges and costs. The study focuses on low-income, diverse patients receiving care at federally qualified health centers in Southern California.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are English or Spanish-speaking, have a history of moderate drug use, and can commit to the study duration.

Not a fit: Patients who are pregnant or those with cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve drug use outcomes and quality of life for patients in primary care settings.

How similar studies have performed: Previous studies have shown success with similar interventions, indicating a promising approach to drug use reduction.

Eligibility criteria

Inclusion Criteria:

* Patients 18 years old and older receiving care at study clinics.
* Have a phone number at which they can be contacted over time during the study (to conduct follow-up health education phone calls).
* Have a primary care visit with a regular clinic provider on the date of recruitment and enrollment.
* English or Spanish-speaking.
* ASSIST score between 4 and 26 indicating risky (moderate) drug use, and used the substance in the past 30 days.
* Able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including and 2-week, 6-week, and 3, 6, 12-month follow-up assessments.
* Planning to be in the Los Angeles area for the next 12 months so they can complete the study period.

Exclusion Criteria:

* Pregnancy: Women who report being pregnant at the time of randomization will be excluded from participation. This latter exclusion criterion is based on the following reasons: (a) The interaction of drug use (in any amount) and fetal-maternal health is physiologically complex and beyond the scope of this proposed intervention. (b) Drug users who are pregnant are considered high-risk pregnancies.
* Repeaters: All patients will be asked a set of repeater questions. This includes a question on whether they have ever been involved in our UCLA study at the clinic before. We will create a unique identifier based on a set of questions that we have used in our prior studies that combines aspects about the potential subject (mother's first name, father's first name, month and day of birth) that will screen them out if they screen again in the future.
* ASSIST Score above 26 indicating high use and potential serious SUD needing referral to specialty treatment: The RA will receive a message that the subject scored 27+ on alcohol or any drugs on the WHO ASSIST (i.e. indication of possible severe substance use disorder). The RA will inform the patient that they are at risk for certain health behaviors and ask the patient if they want to disclose this information to their doctor. If they agree to disclose information to their doctor then we will fill out a letter informing the doctor of patient's potential more serious substance use disorder. We will also provide the patient with a list of local substance use disorder treatment referrals.
* ASSIST Score below 4 (low use): These patients are not eligible for enrollment in the trial.
* Subject Enrolled in a Substance Use Treatment Program: Subjects enrolled in a treatment program are excluded from the study.

Where this trial is running

Long Beach, California and 4 other locations

• The Children's Clinic (TCC) Family Health — Long Beach, California, United States (Recruiting)
• South Central Family Health Clinic — Los Angeles, California, United States (Recruiting)
• Wesley Health Centers — Los Angeles, California, United States (Recruiting)
• Saban Community Clinic — Los Angeles, California, United States (Recruiting)
• UMMA Community Clinic — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Lillian Gelberg, MD, MSPH — University of California, Los Angeles
• Study coordinator: Leticia Cazares, MPH

Conditions Drug Use; risky drug use; mobile phone; self-monitoring; automated feedback; SBIRT