RCT of Woebot for Substance Use Disorders
- Funded by National Institutes of Health (NIH)
- Total publications:0 publications
Grant number: 3R44DA048712-01S1
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Key facts
Disease
COVID-19Start & end year
N/A2020Known Financial Commitments (USD)
$139,951Funder
National Institutes of Health (NIH)Principal Investigator
Athena RobinsonResearch Location
United States of AmericaLead Research Institution
Woebot Labs, Inc.Research Priority Alignment
N/A
Research Category
Therapeutics research, development and implementationResearch Subcategory
Phase 2 clinical trialSpecial Interest Tags
InnovationStudy Type
ClinicalClinical Trial Details
Clinical Trial, Phase IIBroad Policy Alignment
PendingAge Group
UnspecifiedVulnerable Population
Drug usersOccupations of Interest
Unspecified
Abstract
PROJECT SUMMARY / ABSTRACTWoebot for Substance Use Disorders (W-SUDs) is a two-phase NIDA-funded SBIR. Presently,W-SUDs, a novel digital therapeutic, is being evaluated in the Phase I pilot. Phase II willinvestigate W-SUDs's efficacy compared to an active control condition. Since the initial award,and across mere months, Covid-19 became a global pandemic, and users worldwide came toWoebot to discuss it and seek help. The company responded by building and deploying Covid-19 specific programming (W-C19) in March 2020. W-C19 elements have been integrated intoW-SUDs; we felt it was timely and appropriate to address users' concerns about the pandemicand demonstrate that Woebot was 'intelligent' to the crisis. Experts expect Covid-19's direct andindirect impact upon individuals with SUDs to be particularly heavy. These individuals oftenhave physical vulnerabilities, which increase the relative risk of death from Covid-19, and facelimited health care access -- fundamentally challenging given often comorbid mental illness.Moreover, high rates of housing insecurity hinders compliance with shelter-in- place and socialdistancing recommendations, thereby increasing contagion risk. This proposal, with the timelyaddition of a randomized controlled trial comparing W-SUDs to a waitlist control (WL),expands understanding of W-SUDs' efficacy whilst investigating Covid-19's impact uponthe SUD population. Secular trends of increased substance use are anticipated given Covid-19stressors (e.g., shelter-in- place, disease concerns, economic strife, under-/unemployment).Hence, the WL condition is essential for testing W-SUDs' efficacy in mitigating these Covid-19related downstream effects. This proposal extends the parent grant by: (i) adding a randomizedcontrolled evaluation of W-SUDs compared to WL and (ii) investigating potential between groupdifferences on (a) substance use, (b) Covid-19 related components (e.g., social distancing;employment and parental factors), and (c) other SUD treatment engagement. While 20.2 million(8.4%) American adults had a SUD within the past year, only 20% received treatment, givensignificant treatment access barriers [1]. W-SUDs: (i) is poised to reduce or eliminate commonyet significant barriers to traditional SUD treatment; (ii) offers virtual access, optimal for sociallydistancing and shelter-in-place adherence; (iii) has unconstrained and immediate scalepotential; and (iv) delivers content text-based conversation, optimal for engagement. This studyoffers immediate access to a digital therapeutic in a resource constrained, socially distancedhealthcare ecosystem for an already vulnerable and underserved population, likely faced withreadily growing psychological challenges.