Mobile Health Support for Substance Use Reduction

(QUIT-Mobile Trial)

Recruiting at 4 trial locations

Overseen By Leticia Cazares, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Pregnancy, High SUD, Treatment program, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

600 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{1 8 9 10 11}

Research Team

Lillian Gelberg, MD, MSPH

Principal Investigator

University of California, Los Angeles

Dallas Swendeman, PhD, MPH

Principal Investigator

University of California, Los Angeles

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

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

Treatment Details

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.

Participant Groups

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

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

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. 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. Tofighi, B., Grossman, E., Sherman, S., et al.[2018]

A text messaging (SMS) program developed for adult smokers in primary care received high ratings for clarity and usefulness, with 96% of messages rated positively by participants.

Patients expressed a desire for personalized messages, inclusion of e-cigarette information, and graphics, while also identifying gaps in knowledge about nicotine replacement therapy (NRT) safety and effectiveness, highlighting the importance of tailoring interventions to meet smokers' needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Real-Time Ratings With Qualitative Interviews to Develop a Smoking Cessation Text Messaging Program for Primary Care Patients. Kruse, G., Park, ER., Shahid, NN., et al.[2023]

The SMS text-based relapse prevention intervention (RPI) was well received by clients and staff in the NHS Stop Smoking Service, with 70% of participants finding it helpful and 85% responding to interactive messages.

Among the 202 clients who had been abstinent for 4 weeks, 32% maintained continuous abstinence at 6 months, indicating that the RPI may effectively support long-term quitting, although further controlled trials are needed to confirm its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using text messaging to prevent relapse to smoking: intervention development, practicability and client reactions. Snuggs, S., McRobbie, H., Myers, K., et al.[2022]

This systematic review and meta-analysis aims to evaluate the effectiveness of text messaging interventions in reducing alcohol consumption among harmful drinkers, addressing a gap in existing research that has primarily focused on web-based interventions.

The study will assess key outcomes such as weekly alcohol consumption and frequency of heavy drinking, using rigorous methods to ensure the quality of evidence, which could provide valuable insights for health practitioners and policymakers.

NCBI (Pubmed)

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. Bendtsen, M.[2020]

Digital technologies, such as online alcohol questionnaires and mobile applications, are effective in delivering brief interventions for alcohol use disorders, providing reliable responses and comparable outcomes to traditional methods.

The implementation of electronic screening and brief interventions (eSBI) in healthcare settings is still developing, but early evidence suggests they can enhance the prevention of alcohol-related harms and improve the efficiency of healthcare professionals' engagement with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet applications for screening and brief interventions for alcohol in primary care settings - implementation and sustainability. Wallace, P., Bendtsen, P.[2020]

In a study involving 924 smokers using the QuitTxt program, most participants (68.9%) preferred the default messaging frequency of 4-8 texts per day, and the median duration of use was 27 days, indicating a generally positive reception of the program.

Despite some users not fully reporting their quit status, many still found QuitTxt helpful, suggesting that consistent reporting may not be crucial for the program's effectiveness in supporting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? Balmford, J., Borland, R.[2018]

The StAR2D intervention, designed to improve diabetes treatment adherence through SMS text messages, was developed using a systematic four-phase approach that included evidence gathering, message design, stakeholder consultation, and pre-testing in Malawi and South Africa.

The intervention was informed by behavior change theories and tailored to the local context, emphasizing the importance of thorough development processes for effective public health interventions.

NCBI (Pubmed)

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. Leon, N., Namadingo, H., Bobrow, K., et al.[2021]

This systematic review aims to evaluate the effectiveness of mobile health (mHealth) interventions for smoking cessation by analyzing randomized controlled trials, which will help identify how to improve the design of these interventions.

The review will use a random-effects meta-analysis to summarize the effectiveness of mHealth interventions, focusing on self-reported smoking abstinence and service uptake, providing a comprehensive understanding of how mobile phone-based strategies can support smokers in quitting.

NCBI (Pubmed)

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. Kingkaew, P., Glidewell, L., Walwyn, R., et al.[2020]

The Text2Quit program, which sends personalized text messages and emails to support smoking cessation, was well-received by university students, with 90.5% liking the program at 2 weeks and 82.3% at 4 weeks after enrollment.

Participants engaged actively with the program, averaging 11.8 responses to texts in the first 4 weeks, indicating that the interactive features, especially tracking cigarette use, were effective in maintaining user involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. Abroms, LC., Ahuja, M., Kodl, Y., et al.[2022]

References

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

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. [2019]

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]

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

Mobile Phone Messaging During Unobserved "Home" Induction to Buprenorphine. [2018]

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]

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

Using text messaging to prevent relapse to smoking: intervention development, practicability and client reactions. [2022]

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]

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

Internet applications for screening and brief interventions for alcohol in primary care settings - implementation and sustainability. [2020]

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

How do smokers use a smoking cessation text messaging intervention? [2018]

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]

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]

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

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program. [2022]