600 Participants Needed

Mobile Health Support for Substance Use Reduction

(QUIT-Mobile Trial)

Recruiting at 4 trial locations
SS
LC
Overseen ByLeticia Cazares, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.26789

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.1231011

Who Is on the Research Team?

LG

Lillian Gelberg, MD, MSPH

Principal Investigator

University of California, Los Angeles

DS

Dallas Swendeman, PhD, MPH

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.
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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
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks)
  • QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months)
  • Usual Care
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: QUIT-MobileExperimental Treatment1 Intervention
Group III: QUITExperimental Treatment1 Intervention

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:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

University of Arkansas

Collaborator

Trials
500
Recruited
153,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Published Research Related to This Trial

Text messaging interventions for individuals with illicit drug and alcohol dependence are both acceptable and feasible, as shown by a systematic review of 11 studies.
These interventions have been associated with improved clinical outcomes, including better medication adherence and increased engagement with support groups, while also addressing various therapeutic targets like motivation and relapse prevention.
Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature.Tofighi, B., Nicholson, JM., McNeely, J., et al.[2019]
The QUIT-Mobile intervention, which involved mobile-phone delivered self-monitoring surveys and feedback, was found to be feasible and acceptable among 20 participants with risky substance use, primarily Black/African American and Latino men.
Nineteen out of 20 participants reported that the self-monitoring surveys helped them adhere to their drug use reduction goals, indicating that integrating mobile self-monitoring into substance use interventions can enhance self-management and support coaching efforts.
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.Swendeman, D., Sumstine, S., Aguilar, E., et al.[2023]
Health information technologies, like mobile phone applications and electronic health records, can improve treatment outcomes for people with substance use disorders by making evidence-based therapies more accessible and easier to implement.
A clinical case demonstrated that using text messaging for communication between a buprenorphine provider and a patient allowed for effective home induction onto buprenorphine, showing a practical application of technology in managing opioid use disorder.
Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine.Tofighi, B., Grossman, E., Sherman, S., et al.[2018]

Citations

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. [2019]
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]
Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]
Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. [2023]
Using text messaging to prevent relapse to smoking: intervention development, practicability and client reactions. [2022]
Text Messaging Interventions for Reducing Alcohol Consumption Among Harmful and Hazardous Drinkers: Protocol for a Systematic Review and Meta-Analysis. [2020]
Internet applications for screening and brief interventions for alcohol in primary care settings - implementation and sustainability. [2020]
How do smokers use a smoking cessation text messaging intervention? [2018]
Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa. [2021]
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]
11.United Statespubmed.ncbi.nlm.nih.gov
Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. [2022]
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