RCT of Woebot for Substance Use Disorders

  • Funded by National Institutes of Health (NIH)
  • Total publications:0 publications

Grant number: 3R44DA048712-01S1

Grant search

Key facts

  • Disease

    COVID-19
  • Start & end year

    2019
    2020
  • Known Financial Commitments (USD)

    $139,951
  • Funder

    National Institutes of Health (NIH)
  • Principal Investigator

    Athena Robinson
  • Research Location

    United States of America
  • Lead Research Institution

    Woebot Labs, Inc.
  • Research Priority Alignment

    N/A
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Phase 2 clinical trial

  • Special Interest Tags

    Innovation

  • Study Type

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase II

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Drug users

  • Occupations 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.