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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of mobile phone support in helping people reduce risky drug use over a year. Participants will receive either the QUIT-Mobile intervention, which includes a mobile app for tracking and feedback on drug use, standard brief advice from a doctor, or their usual care. The trial specifically targets individuals who have used drugs moderately in the past month and are receiving care at certain clinics in Southern California. Participants should have a phone and be able to communicate in English or Spanish. The goal is to determine which approach best helps people reduce drug use and is most cost-effective. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future drug use interventions.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the QUIT Intervention, one of the treatments under study, effectively reduces risky drug use in past trials. These studies found that patients generally handled the intervention well, with no major side effects linked to the treatment itself. The intervention includes brief advice from doctors and health coaching, both common and safe practices in healthcare.

Regarding the QUIT-Mobile approach, early results suggest that adding mobile phone support, such as self-monitoring and automated feedback, is practical and acceptable to patients. Although limited safety data exists specifically for the mobile component, using mobile phones for health support is common and usually safe. Studies on mobile health support often show that patients accept it well, with no major safety issues.

Both treatments aim to enhance existing healthcare practices with additional support, making them low-risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative ways to support substance use reduction through mobile health technology. The QUIT-Mobile treatment stands out by incorporating a mobile platform that allows for personalized self-monitoring and feedback, which adapts to different patient preferences and literacy levels through web apps, text messages, and automated voice calls. This approach differs from standard care, which typically involves more traditional, face-to-face interventions, by providing continuous, tech-based support that potentially increases engagement and accessibility. Additionally, the QUIT intervention uses a structured, five-step method to directly address substance use behavior, offering a more systematic approach compared to usual care. Overall, these treatments aim to provide more tailored and accessible support, potentially leading to better outcomes in reducing substance use.

What evidence suggests that this trial's treatments could be effective for reducing risky drug use?

Research has shown that the QUIT program, one of the treatment arms in this trial, helps reduce risky drug use. One study found that participants used drugs about 4.5 fewer days per month after following the QUIT plan. This program includes brief advice from doctors and follow-up coaching sessions, which have effectively helped people reduce drug use.

Another treatment arm in this trial, QUIT-Mobile, incorporates self-monitoring and feedback through mobile phones into the QUIT program, aiming to enhance and maintain these reductions. Mobile health tools like apps and text messages have shown promise in helping people adhere to their new drug use habits. Although QUIT-Mobile is a newer method, it builds on the success of the original QUIT program by providing additional support through digital means. ^{1 2 3 6 7}

Who Is on the Research Team?

Lillian Gelberg, MD, MSPH

Principal Investigator

University of California, Los Angeles

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.

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 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?

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+

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.

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 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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4948983/

Project QUIT (Quit Using Drugs Intervention Trial) Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871617302648

A pilot replication of QUIT, a randomized controlled trial ... QUIT (Quit Using Drugs Intervention Trial) brief intervention reduced past month drug use by 4.5 days. •. QUIT protocol was efficacious in a ...

3. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT04935606

mHealth to Enhance & Sustain Drug Use Reduction of the ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5796764/

A pilot replication of QUIT, a randomized controlled trial ... The Quit Using Drugs Intervention Trial (QUIT) is the only primary care-based brief intervention protocol that has shown efficacy for reducing risky drug use ...

5. researchgate.net researchgate.net/publication/282940398_Project_QUIT_Quit_Using_Drugs_Intervention_Trial_A_randomized_controlled_trial_of_a_primary_care-based_multi-component_brief_intervention_to_reduce_risky_drug_use

A randomized controlled trial of a primary care-based multi ... With a slightly more intensive but still limited intervention, Gelberg and colleagues conducted the Quit Using Drugs Intervention Trial (QUIT) ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0376871614009612

Effect of a primary care based brief intervention trial among ... If a patient scored in the risky range on multiple drugs, providers would intervene on the patient's highest scoring drug (HSD) on the ASSIST.

7. scholars.northwestern.edu scholars.northwestern.edu/en/publications/project-quit-quit-using-drugs-intervention-trial-a-randomized-con

A randomized controlled trial of a primary care-based multi ... Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky ...