Drug Use Clinical Trial
— QUIT-MobileOfficial title:
mHealth to Enhance & Sustain Drug Use Reduction of the QUIT BI in Primary Care
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=320/arm, n=960 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).
Status | Recruiting |
Enrollment | 960 |
Est. completion date | March 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years old and older receiving care at study clinics. - Have a phone number at which they can be contacted over time during the study (to conduct follow-up health education phone calls). - Have a primary care visit with a regular clinic provider on the date of recruitment and enrollment. - English or Spanish-speaking. - ASSIST score between 4 and 26 indicating risky (moderate) drug use, and used the substance in the past 30 days. - Able (not cognitively impaired) and willing to cooperate with data collection and research procedures, including and 2-week, 6-week, and 3, 6, 12-month follow-up assessments. - Planning to be in the Los Angeles area for the next 12 months so they can complete the study period. Exclusion Criteria: - Pregnancy: Women who report being pregnant at the time of randomization will be excluded from participation. This latter exclusion criterion is based on the following reasons: (a) The interaction of drug use (in any amount) and fetal-maternal health is physiologically complex and beyond the scope of this proposed intervention. (b) Drug users who are pregnant are considered high-risk pregnancies. - 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. We will create a unique identifier based on a set of questions that we have used in our prior studies that combines aspects about the potential subject (mother's first name, father's first name, month and day of birth) that will screen them out if they screen again in the future. - ASSIST Score above 26 indicating high use and potential serious SUD needing referral to specialty treatment: The RA will receive a message that the subject scored 27+ on alcohol or any drugs on the WHO ASSIST (i.e. indication of possible severe substance use disorder). The RA will inform the patient that they are at risk for certain health behaviors and ask the patient if they want to disclose this information to their doctor. If they agree to disclose information to their doctor then we will fill out a letter informing the doctor of patient's potential more serious substance use disorder. We will also provide the patient with a list of local substance use disorder treatment referrals. - ASSIST Score below 4 (low use): These patients are not eligible for enrollment in the trial. - Subject Enrolled in a Substance Use Treatment Program: Subjects enrolled in a treatment program are excluded from the study. |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Clinic (TCC) Family Health | Long Beach | California |
United States | Saban Community Clinic | Los Angeles | California |
United States | South Central Family Health Clinic | Los Angeles | California |
United States | UMMA Community Clinic | Los Angeles | California |
United States | Wesley Health Centers | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Medical University of South Carolina, National Institute on Drug Abuse (NIDA), University of Arkansas |
United States,
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Bone C, Gelberg L, Vahidi M, Leake B, Yacenda-Murphy J, Andersen RM. Under-reporting of Risky Drug Use Among Primary Care Patients in Federally Qualified Health Centers. J Addict Med. 2016 Nov/Dec;10(6):387-394. doi: 10.1097/ADM.0000000000000246. — View Citation
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Gelberg L, Andersen RM, Rico MW, Vahidi M, Natera Rey G, Shoptaw S, Leake BD, Serota M, Singleton K, Baumeister SE. A pilot replication of QUIT, a randomized controlled trial of a brief intervention for reducing risky drug use, among Latino primary care patients. Drug Alcohol Depend. 2017 Oct 1;179:433-440. doi: 10.1016/j.drugalcdep.2017.04.022. Epub 2017 Jun 13. — View Citation
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Padwa H, Ni YM, Barth-Rogers Y, Arangua L, Andersen R, Gelberg L. Barriers to drug use behavior change among primary care patients in urban United States community health centers. Subst Use Misuse. 2014 May;49(6):743-51. doi: 10.3109/10826084.2013.866962. Epub 2013 Dec 20. — View Citation
Reddy AT, Andersen RM, Gelberg L. Clinicians' Beliefs and Practices Regarding Drug Use Care of Their Community Health Center Patients. J Addict Med. 2015 Nov-Dec;9(6):447-53. doi: 10.1097/ADM.0000000000000158. — View Citation
Singleton KW, Lan M, Arnold C, Vahidi M, Arangua L, Gelberg L, Bui AA. Wireless data collection of self-administered surveys using tablet computers. AMIA Annu Symp Proc. 2011;2011:1261-9. Epub 2011 Oct 22. — View Citation
Swendeman D, Sumstine S, Aguilar E, Gorbach PM, Comulada WS, Gelberg L. 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. J Addict Med. 2021 Apr 1;15(2):120-129. doi: 10.1097/ADM.0000000000000707. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug Use | 30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at baseline. | Baseline | |
Primary | Drug Use | 30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 3-month follow-up. | 3-month follow-up | |
Primary | Drug Use | 30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 6-month follow-up. | 6-month follow-up | |
Primary | Drug Use | 30-day self-reports of drug use (due to sporadic use patterns of moderate/risky drug users) with urine screen to validate underreporting given detection windows of 1-3 days for most drugs (except cannabis) measured at 12-month follow-up. | 12-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (SF-12) | Mental health status/QoL (SF-12):
i. Physical Functioning: [1=Yes, Limited A Lot; 3= No, Not Limited At All] ii. Role- Physical: [1=Yes; 2=No] iii. Bodily Pain: [1=Not At All; 5=Extremely] iv. General Health: [1=Excellent; 5=Poor] v. Vitality: [1=All of the Time; 6=None of the Time] vi. Social Functioning: [1=All of the Time; 6=None of the Time] vii. Role- Emotional: [1=Yes; 2=No] viii. Mental Health [1=All of the Time; 6=None of the Time] |
Baseline | |
Secondary | Health-related Quality of Life Improvement Self-Reports (SF-12) | Mental health status/QoL (SF-12):
i. Physical Functioning: [1=Yes, Limited A Lot; 3= No, Not Limited At All] ii. Role- Physical: [1=Yes; 2=No] iii. Bodily Pain: [1=Not At All; 5=Extremely] iv. General Health: [1=Excellent; 5=Poor] v. Vitality: [1=All of the Time; 6=None of the Time] vi. Social Functioning: [1=All of the Time; 6=None of the Time] vii. Role- Emotional: [1=Yes; 2=No] viii. Mental Health [1=All of the Time; 6=None of the Time] |
3-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (SF-12) | Mental health status/QoL (SF-12):
i. Physical Functioning: [1=Yes, Limited A Lot; 3= No, Not Limited At All] ii. Role- Physical: [1=Yes; 2=No] iii. Bodily Pain: [1=Not At All; 5=Extremely] iv. General Health: [1=Excellent; 5=Poor] v. Vitality: [1=All of the Time; 6=None of the Time] vi. Social Functioning: [1=All of the Time; 6=None of the Time] vii. Role- Emotional: [1=Yes; 2=No] viii. Mental Health [1=All of the Time; 6=None of the Time] |
6-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (SF-12) | Mental health status/QoL (SF-12):
i. Physical Functioning: [1=Yes, Limited A Lot; 3= No, Not Limited At All] ii. Role- Physical: [1=Yes; 2=No] iii. Bodily Pain: [1=Not At All; 5=Extremely] iv. General Health: [1=Excellent; 5=Poor] v. Vitality: [1=All of the Time; 6=None of the Time] vi. Social Functioning: [1=All of the Time; 6=None of the Time] vii. Role- Emotional: [1=Yes; 2=No] viii. Mental Health [1=All of the Time; 6=None of the Time] |
12-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (MHI) | Two additional mental health questions will be collected at baseline, 3-, 6-, and 12-months follow-ups using the Mental Health Inventory (MHI) survey :
i. "How much of the time during the past 4 weeks:" Have you been a very nervous person? [1=All of the Time; 6=None of the Time] Have you felt so down in the dumps that nothing could cheer you up? [1=All of the Time; 6=None of the Time] |
Baseline | |
Secondary | Health-related Quality of Life Improvement Self-Reports (MHI) | Two additional mental health questions will be collected at baseline, 3-, 6-, and 12-months follow-ups using the Mental Health Inventory (MHI) survey :
i. "How much of the time during the past 4 weeks:" Have you been a very nervous person? [1=All of the Time; 6=None of the Time] Have you felt so down in the dumps that nothing could cheer you up? [1=All of the Time; 6=None of the Time] |
3-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (MHI) | Two additional mental health questions will be collected at baseline, 3-, 6-, and 12-months follow-ups using the Mental Health Inventory (MHI) survey :
i. "How much of the time during the past 4 weeks:" Have you been a very nervous person? [1=All of the Time; 6=None of the Time] Have you felt so down in the dumps that nothing could cheer you up? [1=All of the Time; 6=None of the Time] |
6-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (MHI) | Two additional mental health questions will be collected at baseline, 3-, 6-, and 12-months follow-ups using the Mental Health Inventory (MHI) survey :
i. "How much of the time during the past 4 weeks:" Have you been a very nervous person? [1=All of the Time; 6=None of the Time] Have you felt so down in the dumps that nothing could cheer you up? [1=All of the Time; 6=None of the Time] |
12-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (WHOQoLBREF) | Insomnia (WHOQoLBREF) as assessed by, "Do you have any difficulties with sleeping?" [1=Not at all; 5=An extreme amount] | Baseline | |
Secondary | Health-related Quality of Life Improvement Self-Reports (WHOQoLBREF) | Insomnia (WHOQoLBREF) as assessed by, "Do you have any difficulties with sleeping?" [1=Not at all; 5=An extreme amount] | 3-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (WHOQoLBREF) | Insomnia (WHOQoLBREF) as assessed by, "Do you have any difficulties with sleeping?" [1=Not at all; 5=An extreme amount] | 6-month follow-up | |
Secondary | Health-related Quality of Life Improvement Self-Reports (WHOQoLBREF) | Insomnia (WHOQoLBREF) as assessed by, "Do you have any difficulties with sleeping?" [1=Not at all; 5=An extreme amount] | 12-month follow-up | |
Secondary | Health Service Utilizations | Health services utilization self-reports using 6- and 12-month recall periods of: # ED visits, # hospitalizations, # hospital days, # and type of outpatient visits. Self-reports are valid for 12-month recall. Electronic Health Records will be reviewed for additional data. | Baseline | |
Secondary | Health Service Utilizations | Health services utilization self-reports using 6- and 12-month recall periods of: # ED visits, # hospitalizations, # hospital days, # and type of outpatient visits. Self-reports are valid for 12-month recall. Electronic Health Records will be reviewed for additional data. | 3-month follow-up | |
Secondary | Health Service Utilizations | Health services utilization self-reports using 6- and 12-month recall periods of: # ED visits, # hospitalizations, # hospital days, # and type of outpatient visits. Self-reports are valid for 12-month recall. Electronic Health Records will be reviewed for additional data. | 6-month follow-up | |
Secondary | Health Service Utilizations | Health services utilization self-reports using 6- and 12-month recall periods of: # ED visits, # hospitalizations, # hospital days, # and type of outpatient visits. Self-reports are valid for 12-month recall. Electronic Health Records will be reviewed for additional data. | 12-month follow-up | |
Secondary | 30-day Timeline Follow Back (TLFB) of Drug Use | TLFB will be assessed by including a calendar in the study web application where participants will click each day they used their highest scoring drug. Reported use on each day is then summed to achieve a summary score for the total number of days that drugs were used. | Baseline | |
Secondary | 30-day Timeline Follow Back (TLFB) of Drug Use | TLFB will be assessed by including a calendar in the study web application where participants will click each day they used their highest scoring drug. Reported use on each day is then summed to achieve a summary score for the total number of days that drugs were used. | 3-month follow-up | |
Secondary | 30-day Timeline Follow Back (TLFB) of Drug Use | TLFB will be assessed by including a calendar in the study web application where participants will click each day they used their highest scoring drug. Reported use on each day is then summed to achieve a summary score for the total number of days that drugs were used. | 6-month follow-up | |
Secondary | 30-day Timeline Follow Back (TLFB) of Drug Use | TLFB will be assessed by including a calendar in the study web application where participants will click each day they used their highest scoring drug. Reported use on each day is then summed to achieve a summary score for the total number of days that drugs were used. | 12-month follow-up |
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