Protocol Description

Medication-assisted treatment, the current standard for opioid addiction, is the use of medications in combination with counseling and behavioral therapies to provide a “whole-patient” approach to the treatment of opioid use disorder (OUD). However, patients may not have optimal access to face-to-face clinical behavioral health services. Digital therapeutics can help bridge the gap between accessible services and optimal treatment of OUD, the primary goal of which is to reduce the use of opioids. OXD01 is a device-based digital therapeutic, designed to offer individuals diagnosed with OUD quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing. This study is being conducted to determine the value of OXD01 when combined with medication to change opioid use patterns in subjects with OUD.


Eligibility Criteria

You may be eligible to participate in this study if you meet the following criteria:

Inclusion criteria:

  1. Male or female 18 – 65 years of age at the screening visit, fluent in English and able to read, comprehend, and willingly sign the informed consent form (ICF)
  2. Voluntarily seeking treatment for OUD
  3. In the judgment of the Investigator, has the appropriate hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand internet-based applications
  4. Has a positive urine drug screen (UDS) for opioids at screening that is consistent with their drug use history
  5. In good health as determined by lack of clinically significant abnormalities in health assessments performed at screening
  6. Agrees not to take any buprenorphine products other than those prescribed by the Investigator during participation in the study and agrees to use OXD01 as directed if randomized to that treatment group


Clinical Trial Investigator

Dr. Aimee Gonzalez, Principal Investigator