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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
QUIT-Mobile Trial 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.Check my eligibility
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.See study design
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.
QUIT-Mobile Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Drug Use
Secondary outcome measures
30-day Timeline Follow Back (TLFB) of Drug Use
Health Service Utilizations
Health-related Quality of Life Improvement Self-Reports (MHI)
+2 moreQUIT-Mobile 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
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,264,308 Total Patients Enrolled
7 Trials studying Substance Use
3,731 Patients Enrolled for Substance Use
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,618,770 Total Patients Enrolled
68 Trials studying Substance Use
37,926 Patients Enrolled for Substance Use
University of ArkansasOTHER
486 Previous Clinical Trials
149,393 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I can and will follow the study's data collection and follow-up schedule.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: QUIT
- Group 3: QUIT-Mobile
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Substance Use Patient Testimony for trial: Trial Name: NCT04935606 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open spots remaining in this experiment?
"That is accurate. According to the records on clinicaltrials.gov, this medical trial was initially posted in June 2021 and updated as recently as March 2022. The investigation seeks 960 individuals from 2 distinct health centres for inclusion."
Answered by AI
What is the recruitment capacity of this research?
"Affirmative. Clinicaltrials.gov has corroborated that this clinical trial was posted on June 1st 2021 and last amended on March 11th 2022; it is currently searching for 960 participants across two sites."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Kansas
What site did they apply to?
Saban Community Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I love knowing that I could help others and make a difference. The consequences from being a substance abuse user has always negatively effected myself and others around me. Being able to provide a positive outcome, help someone,or even just making a difference in a good way I feel is the least I could due after all the damage that has been done from using drugs.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Are we able to know the final research information gathered from this trial?
PatientReceived 2+ prior treatments
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