Mobile Health Support for Substance Use Reduction

(QUIT-Mobile Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Lillian Gelberg, MD, MSPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, Los Angeles

Disqualifiers: Pregnancy, High SUD, Treatment program, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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, delivered by paraprofessional health coaches. QUIT-Mobile tests the addition of mobile phone self-monitoring, automated feedback, and coach monitoring dashboard to enhance and sustain QUIT\'s drug use reductions using mobile-web app, text-messaging (SMS), or interactive voice response (IVR).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on reducing risky drug use, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the QUIT-Mobile treatment for substance use reduction?

Research shows that mobile phone-based interventions, like text messaging, can help people reduce risky substance use and prevent addiction. These interventions are feasible and well-received, and they have been effective in helping people quit smoking and manage substance use disorders.

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Is the QUIT-Mobile intervention safe for humans?

The available research on the QUIT-Mobile intervention and similar mobile health interventions suggests they are generally safe for humans, as they focus on self-monitoring and feedback through mobile phones, which are widely used technologies. No specific safety concerns have been reported in the studies reviewed.

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What makes the QUIT-Mobile treatment unique for substance use reduction?

The QUIT-Mobile treatment is unique because it combines traditional doctor advice and health coaching with a mobile-web app or text message system for self-monitoring and automated feedback over 12 months, offering continuous support and interaction to help reduce substance use.

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Eligibility Criteria

This trial is for adults over 18 with moderate drug use, as indicated by an ASSIST score of 4-26, who have used substances in the past month. Participants must be receiving care at study clinics, speak English or Spanish, and plan to stay in Los Angeles for a year. Pregnant women, those already in substance treatment programs or with severe substance use disorders are excluded.

Inclusion Criteria

I have an appointment with my regular doctor on the day I join the study.

I am 18 or older and receiving care at a study clinic.

I have a phone number for ongoing contact during the study.

Exclusion Criteria

ASSIST Score below 4 (low use)

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

ASSIST Score above 26 indicating high use and potential serious SUD needing referral to specialty treatment

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the QUIT intervention, which includes patient screening, brief clinician advice, video doctor reinforcement, and telephone health coaching calls at 2 and 6 weeks.

6 weeks

2 telephone coaching sessions

Mobile Monitoring

Participants engage in self-monitoring of drug use and receive automated feedback via mobile app, SMS, or IVR from 6 weeks to 12 months.

46 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months.

12 months

3 follow-up assessments

Participant Groups

The QUIT-Mobile study tests if mobile phone self-monitoring can improve and maintain reduced risky drug use over a year after the initial QUIT intervention. It's a three-arm RCT comparing QUIT-Mobile (mobile-web app or texts), standard QUIT (brief advice and health coaching), and usual care.

Group I: Usual Care Experimental Treatment 1 Intervention

Usual Care participants will receive their standard medical care as usual (no provider advice or telephone coaching sessions) and all screening and study assessments. To reduce biases, Usual Care arm patients will be given a cancer screening booklet and will be shown a cancer screening Video Doctor. They will also receive 2 re-contact telephone sessions at weeks 2 and 6 corresponding to the timing of the coaching sessions for the QUIT and QUIT-Mobile arms. All participants will also receive re-contact calls monthly from 7-weeks to 12-months. The re-contact calls (5 min) provide attention control for the Usual Care arm, motivate continued trial participation by reminding them of the next research assessment, but do not provide an active intervention. At study end, the Usual Care arm will receive the QUIT video doctor and drug use reduction booklet brochure materials including overdose prevention materials and a list of clinic/community resources to help them reduce substance use.

Group II: QUIT-Mobile Experimental Treatment 1 Intervention

QUIT-Mobile will include a mobile platform with self-monitoring surveys and feedback message and robust data transfer protocols across three mobile technology platforms to meet diverse patient's preferences and needs regardless of literacy and phone type: a mobile-optimized web-app (using any smart phone's web-browser, not "native" apps), SMS (text-messaging), and IVR (automated voice calls for low literacy patients). Data collected during this study on patient platform preferences and exploratory analyses on intervention efficacy across platform types will inform the development of future effectiveness trials that can evaluate effectiveness of different mobile platforms.

Group III: QUIT Experimental Treatment 1 Intervention

The QUIT brief intervention protocol will consist of 5 steps corresponding to the 5A's approach for assisting behavior change in the clinic setting (Ask, Advise, Assess, Assist, and Arrange) that will focus on patients' HSD (highest scoring drug on the baseline ASSIST) use in the past 30 days.

QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks) is already approved in United States for the following indications:

🇺🇸 Approved in United States as QUIT Intervention for:

• Substance use disorder
• Risky drug use

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Children's Clinic (TCC) Family Health Long Beach, CA

South Central Family Health Clinic Los Angeles, CA

Wesley Health Centers Los Angeles, CA

UMMA Community Clinic Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

University of California, Los Angeles Lead Sponsor

National Institute on Drug Abuse (NIDA) Collaborator

University of Arkansas Collaborator

Medical University of South Carolina Collaborator

References

1. Australia pubmed.ncbi.nlm.nih.gov

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. [2019] Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Mobile Phone Self-monitoring and Automated Feedback to Enhance Telephone Coaching for People With Risky Substance Use: The QUIT-Mobile Pilot Study. [2023] This study evaluates the feasibility, acceptability, and perceived benefits of mobile-phone delivered self-monitoring queries and feedback integrated into the evidence-based Quit Using Drugs Intervention Trial (QUIT) screening and brief telephone health coaching intervention to prevent progression from risky drug use to addiction as the QUIT-Mobile intervention.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018] The deployment of health information technologies promises to optimize clinical outcomes for populations with substance use disorders. Electronic health records, web-based counseling interventions, and mobile phone applications enhance the delivery of evidence-based behavioral and pharmacological treatments, with minimal burden to clinical personnel, infrastructure, and work flows. This clinical case shares a recent experience utilizing mobile phone text messaging between an office-based buprenorphine provider in a safety net ambulatory clinic and a patient seeking buprenorphine treatment for opioid use disorder. The case highlights the use of text message-based physician-patient communication to facilitate unobserved "home" induction onto buprenorphine.

4. Canada pubmed.ncbi.nlm.nih.gov

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. [2023] Text messaging (short message service, SMS) interventions show promise as a way to help cigarette smokers quit. Few studies have examined the effectiveness of text messaging (SMS) programs targeting smokers associated with primary care or hospital settings.

5. England pubmed.ncbi.nlm.nih.gov

Using text messaging to prevent relapse to smoking: intervention development, practicability and client reactions. [2022] The NHS Stop Smoking Service (NHS-SSS) helps approximately half its clients to quit for 4 weeks. However, most initially successful quitters relapse within 6 months. Short message service (SMS) texting has been shown to facilitate stopping smoking. We describe the development, implementation and subsequent evaluation, in terms of practicability and client response, of an SMS text-based relapse prevention intervention (RPI) delivered within routine community and specialist National Health Service (NHS) Stop Smoking Service (SSS) provision in four Primary Care Trusts.

6. Canada pubmed.ncbi.nlm.nih.gov

Text Messaging Interventions for Reducing Alcohol Consumption Among Harmful and Hazardous Drinkers: Protocol for a Systematic Review and Meta-Analysis. [2020] Mobile phone-based interventions have become popular for lifestyle behavior change, particularly the use of text messaging as it is a technology ubiquitous in mobile phones. Reviews and meta-analyses of digital interventions for reducing harmful and hazardous use of alcohol have mainly focused on Web-based interventions; thus, there is a need for a body of evidence to guide health practitioners, policy makers, and researchers with respect to the efficacy of available text messaging interventions.

7. Switzerland pubmed.ncbi.nlm.nih.gov

Internet applications for screening and brief interventions for alcohol in primary care settings - implementation and sustainability. [2020] Screening and brief interventions head the list of effective evidence-based interventions for the prevention and treatment of alcohol use disorders in healthcare settings. However, healthcare professionals have been reluctant to engage with this kind of activity both because of the sensitive nature of the subject and because delivery is potentially time-consuming. Digital technologies for behavioral change are becoming increasingly widespread and their low delivery costs make them highly attractive. Internet and mobile technologies have been shown to be effective for the treatment of depression, anxiety, and smoking cessation in healthcare settings, and have the potential to add substantial value to the delivery of brief intervention for alcohol. Online alcohol questionnaires have been shown to elicit reliable responses on alcohol consumption and compared with conventional prevention techniques, digital alcohol interventions delivered in various settings have been found to be as effective in preventing alcohol-related harms. The last decade has seen the emergence of a range of approaches to the implementation in health care settings of referral to Internet-based applications for screening and brief interventions (eSBI) for alcohol. Research in this area is in its infancy, but there is a small body of evidence providing early indications about implementation and sustainability, and a number of studies are currently underway. This paper examines some of the evidence emerging from these and other studies and assesses the implications for the future of eSBI delivery in primary care settings.

8. England pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? [2018] Mobile-phone-based text (SMS) messaging is an effective method for delivering smoking cessation assistance; however, little is known about optimal program use. This paper reports on the use of 2 forms of interaction (reporting changes in quit status and emergency help) among users of QuitTxt, an interactive, automated text messaging advice program. We examined preferences for messaging intensity, duration of use, and their associations with short-term cessation outcome or perceived helpfulness.

9. England pubmed.ncbi.nlm.nih.gov

Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa. [2021] Brief messaging interventions, including Short Message Service (SMS) text-messages, delivered via mobile device platforms, show promise to support and improve treatment adherence. To understand how these interventions work, and to facilitate transparency, we need clear descriptions of the intervention development process.

10. England pubmed.ncbi.nlm.nih.gov

Identifying effective components for mobile health behaviour change interventions for smoking cessation and service uptake: protocol of a systematic review and planned meta-analysis. [2020] Mobile health (mHealth) interventions for smoking cessation have been shown to be associated with an increase in effectiveness. However, interventions using mobile phones to change people's behaviour are often perceived as complex interventions, and the interactions between several components within them may affect the outcome. Therefore, it is important to understand how we can improve the design of mHealth interventions using mobile phones as a medium to deliver services.

11. United States pubmed.ncbi.nlm.nih.gov

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. [2022] Text messaging programs on mobile phones have shown some promise in helping people quit smoking. Text2Quit is an automated, personalized, and interactive mobile health program that sends text messages and e-mails timed around a participant's quit date over the course of 3 months. The text messages include pre- and post-quit educational messages, peer ex-smoker messages, medication reminders and relapse messages, and multiple opportunities for interaction. Study participants were university students (N = 23) enrolled in the Text2Quit program. Participants were surveyed at baseline and at 2 and 4 weeks after enrollment. The majority of participants agreed that they liked the program at 2 and 4 weeks after enrollment (90.5% and 82.3%, respectively). Support for text messages was found to be moderate and higher than that of the e-mail and web components. Of participants, 75% reported reading most or all of the texts. On average, users made 11.8 responses to the texts over a 4-week period, although responses declined after the quit date. The interactive feature for tracking cigarettes was the most used interactive feature, followed by the craving trivia game. This pilot test provides some support for the Text2Quit program. A future iteration of the program will include additional tracking features in both the pre-quit and post-quit protocols and an easier entry into the not-quit protocol. Future studies are recommended that identify the value of the interactive and personalized features that characterize this program.