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Mobile Health Support for Substance Use Reduction (QUIT-Mobile Trial)

N/A

Recruiting

Led By Lillian Gelberg, MD, MSPH

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using a mobile phone to monitor and give feedback on drug use will help reduce risky drug use better than just providing standard brief intervention and advice or than doing nothing special.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected. However, participants may experience discomfort from discussing personal substance use habits during counseling sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Drug Use

Secondary study objectives

30-day Timeline Follow Back (TLFB) of Drug Use

Health Service Utilizations

Health-related Quality of Life Improvement Self-Reports (MHI)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Usual CareExperimental Treatment1 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-MobileExperimental Treatment1 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: QUITExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

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