A Randomized, Open-label, Parallel-group Study to Evaluate the Efficacy of the Digital Therapeutic OXD01 (MODIA™) in Combination With Sublingual Buprenorphine/Naloxone for the Treatment of Opioid Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Orexo AB
- Enrollment
- 437
- Locations
- 21
- Primary Endpoint
- Treatment Success Rate
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with opioid use disorder (OUD).
Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a urine drug screen (UDS) and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a UDS and a self-report of drug use each week between the evaluation visits.
The primary objective of the 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 SL BUP/NAL alone to reduce opioid use.
Detailed 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 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. Note: No investigational product will be administered as part of this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
- •Voluntarily seeking treatment for OUD.
- •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.
- •Currently meets the criteria for moderate or severe opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (Appendix B).
- •Has a positive UDS for opioids at screening that is consistent with their drug use history.
- •In good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- •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.
- •Completed SL BUP/NAL induction, with physical withdrawal symptoms reduced so the subject is able to fulling participate in OXD01 training, if randomized to that treatment group, and is no greater than 14 days from the first dose of SL BUP/NAL induction.
Exclusion Criteria
- •Unwilling or unable to comply with the requirements of the protocol or are in a situation or condition that, in the opinion of an Investigator, may interfere with participation in the study (e.g., does not have reliable internet access).
- •History of allergy or sensitivity to naloxone, buprenorphine or other opioids, or history of any drug hypersensitivity or intolerance which, in the opinion of an Investigator, would compromise the safety of the subject.
- •Used an investigational drug within 30 days or 5 half-lives (whichever is greater) prior to randomization.
- •Received prescribed medication-assisted treatment with buprenorphine, methadone, or naltrexone for opioid use disorder within 14 days prior to screening.
- •Past or present diseases that, judged 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.
- •Tongue piercing, or piercings in the mouth or oral deformities that may affect sublingual absorption, in the opinion of an Investigator.
- •Hospitalization for a psychiatric disorder in the past 30 days, not including inpatient treatment for drug rehabilitation.
- •Schizophrenia, or other serious mental illness defined as a mental, behavioral, or emotional disorder resulting in serious functional impairment which substantially interferes with or limits participation in the study.
- •A Quick Inventory of Depression Symptoms - Self-Report (QIDS-SR, Appendix C) score ≥ 16 (severe depression) or a rating of 2 or 3 for question 12 (Thoughts of Death or Suicide) at screening.
- •A current diagnosis, other than opioid use disorder, requiring chronic opioid treatment.
Outcomes
Primary Outcomes
Treatment Success Rate
Time Frame: Week 6 to Week 25
The primary objective was to determine whether the combination of sublingual buprenorphine/naloxone (SL BUP/NAL) and OXD01 was superior to SL BUP/NAL alone to reduce opioid use, measured by the treatment success rate. Treatment success was defined as the subject having \>/=80% of urine drug tests negative for opioids plus \>/=80% of self-reports negative for illicit opioid use from Week 6 to Week 25. Each subject was evaluated as a success or failure for this metric. The percentage of subjects in each group demonstrating treatment success was tested using the Chi-square test. If the subject withdrew from the study, the urine drug tests and self-reports for illicit opioid use for all visits after withdrawal were imputed as positive. If the subject completed the study with missing visits, the missing urine drug tests and self-reports for illicit opioids were imputed as positive.
Secondary Outcomes
- Overdose Events(Weeks 1-25)
- Cumulative Response Rate(Week 6 to Week 25)
- Cumulative Response Rate - Drug Test for Illicit Use of Opioids(Week 6 to Week 25)
- Cumulative Response Rate - Self-reports of Illicit Use of Opioids(Week 6 to Week 25)
- Percentage of Subjects Abstinent(Week 25)
- Proportion of Subjects Completing the Study(Week 25)
- Global Clinical Impression - Severity(Week 13 and Week 25)
- Clinical Global Impression - Improvement(Week 13 and Week 25)
- Opioid Cravings - Change From Baseline(Day 1 (baseline) and Weeks 5, 9, 13, 17, 21 and 25.)
- Cumulative Response Rate - Illicit Non-opioid Drugs of Abuse(Week 6 to Week 25)
- Resource Use - Emergency Department Visits(Weeks 1-25)
- Resource Use - Number of Hospitalizations(Weeks 1-25)
- Resume Productive Activity(Week 25)