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Digital Therapeutics

Digital Therapeutics for Substance Use Disorders (DIGITS Pilot Trial)

N/A
Waitlist Available
Led By Joseph E Glass, PhD, MSW
Research Sponsored by Kaiser Permanente
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 6 months
Awards & highlights

DIGITS Pilot Trial Summary

This trial is testing digital treatments for opioids and other substance use disorders in primary care. The study will test and refine two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing).

Who is the study for?
This trial is for adults over 18 who have visited a participating primary care clinic, screened positive for substance use disorders like opioid abuse or alcohol misuse. There are no specific exclusion criteria, making it broadly accessible to those seeking help.Check my eligibility
What is being tested?
The study tests digital treatments called reSET and reSET-O in primary care settings. It explores how health coaching for patients and practice facilitation for clinicians can aid the implementation of these digital therapies as part of quality improvement efforts.See study design
What are the potential side effects?
Since this trial focuses on implementing digital therapeutics rather than medication, traditional side effects are not a concern. However, participants may experience challenges related to adapting to new technology or changes in their treatment routine.

DIGITS Pilot Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fidelity of patients use of the digital therapeutic to clinical recommendations
Reach of the digital therapeutic to patients in the primary care clinic
Secondary outcome measures
Effectiveness
Other outcome measures
Adoption
Fidelity-2
Fidelity-3
+2 more

DIGITS Pilot Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard Implementation Plus Health Coaching and Practice FacilitationExperimental Treatment3 Interventions
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O. Additionally, a practice facilitator will provide the clinic with support for implementation.
Group II: Standard Implementation Plus Health CoachingExperimental Treatment2 Interventions
The clinic in this arm will implement reSET and reSET-O with a standard implementation strategy and patients at the clinic will receive support from a health coach to help them engage with reSET and reSET-O.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health Coaching
2018
N/A
~1880
Practice Facilitation
2007
N/A
~17800
Standard Implementation
2017
N/A
~1990

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
534 Previous Clinical Trials
24,109,814 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,447 Previous Clinical Trials
2,593,366 Total Patients Enrolled
Joseph E Glass, PhD, MSWPrincipal InvestigatorKaiser Permanente
1 Previous Clinical Trials
13,000 Total Patients Enrolled

Media Library

reSET (Digital Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT04907045 — N/A
Alcohol Use Disorder Research Study Groups: Standard Implementation Plus Health Coaching, Standard Implementation Plus Health Coaching and Practice Facilitation
Alcohol Use Disorder Clinical Trial 2023: reSET Highlights & Side Effects. Trial Name: NCT04907045 — N/A
reSET (Digital Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907045 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are engaged with the current research study?

"Affirmative. According to clinicaltrials.gov, this research is recruiting participants with the original listing posted on May 6th 2021 and last updated on January 3rd 2022; it requires 700 volunteers from a single location."

Answered by AI

Is recruitment still open for participation in this experiment?

"This clinical trial is actively searching for participants, with the initial posting taking place on May 6th 2021 and being most recently updated in January 3rd 2022."

Answered by AI
~175 spots leftby Mar 2025