Addiction - Opioid Use Disorder Study

Quality Psychotherapy Intervention

One challenge for healthcare providers working on the front of the current opioid crisis is to improve the availability and access to treatment, particularly behavioral health services. The evidence is that many patients who require behavioral health services are not getting access or chose not to engage in face-to-face therapy. New modes of service delivery are necessary to close the gap between patients and the treatment required for recovery from addiction.

Currently, patients do not have the accessibility to have face-to-face clinical behavioral health services. So, what would happen if you added Digital therapeutics into the mix to help bridge the gap between accessible services and optimal treatment of OUD?

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. The study is being conducted to determine the value of OXD01 when combined with medication to change opioid use patterns in subjects with OUD.

Primary Objective of the Study

The primary objective of this study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to BUP/NAL alone to reduce opioid use.

The results are going to be measured by the treatment success rate.

The study participants will receive compensation up to $780 for time and travel.

Selected Inclusion Criteria

1. Voluntarily seeking treatment for OUD.
2. Has a positive UDS for opioids at screening that is consistent with your drug use history.
3. Agrees not to take any buprenorphine products other than those prescribed by the investigator during participation in the study and agrees to use OXDO1 as directed if randomized to that treatment group.
4. Completed SL BUP/NAL induction, with physical withdrawal symptoms reduced so you can fully participate in OXDO1 training (if randomized to that group).
5. No greater than 14 days from the first dose of SL BUP/NAL induction.

Selected Exclusion Criteria

1. Unwilling or unable to comply with the requirements of the protocol or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study (e.g., does not have reliable internet access)

2. Received prescribed medication-assisted treatment with buprenorphine, methadone, or naltrexone for opioid use disorder within 14 days prior to screening.

3. Tongue piercing, or piercings in the mouth or oral deformities that may affect sublingual absorption.

4. Past or present diseases that, judge by an investigator and based on available medical history/records, may jeopardize the safety of the subject, or impact the validity of the study results.

5. Hospitalization for a psychiatric disorder in the past 30 days, not including inpatient treatment for drug rehabilitation.

The Process

Approximately 510 opioid dependent males and females will be screened to randomize approximately 400 subjects. Subjects will be scheduled for evaluation visits, which will include a UDS and a self-report of drug use, weekly during the first four weeks of treatment, every other week from weeks 5 through 12, and monthly through 24 weeks. Subjects will also return to the site for a UDS, and a self-report of drug use each week between the evaluation visits.