OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

NCT04948307 | Completed Results FDA Device

• 1 other identifier: OXD01-001
• Study Type: interventional
• Target: 437
• Locations: 1 country
• Sites: 21

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.

Conditions

Opioid-use Disorder

Keywords

digital therapy; cognitive behavioral therapy (CBT)

Outcome Measures

Primary Outcomes (1)

• Treatment Success Rate

  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.

  Week 6 to Week 25

Secondary Outcomes (13)

• 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

Study Arms (2)

Sublingual buprenorphine/naloxone (SL BUP/NAL) standard of care (SOC) background therapy

OTHER

Standard of care. Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice.

Other: Standard of Care

Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01

EXPERIMENTAL

Standard of care + OXD01 (digital therapy). Subjects in both groups will receive the assigned treatment for 24 weeks. Subjects in both groups may also be encouraged to participate in behavioral health therapies in accordance with the Investigator's standard of practice.

Device: OXD01 digital therapy; Other: Standard of Care

Interventions

OXD01 digital therapy DEVICE

OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.

Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01

Standard of Care OTHER

Sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling

Sublingual buprenorphine/naloxone (SL BUP/NAL) + OXD01; Sublingual buprenorphine/naloxone (SL BUP/NAL) standard of care (SOC) background therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Chronic pain that is unremitting or unstable. 12. Current DSM-V diagnosis of moderate to severe substance use disorder for psychoactive substances other than opioids, caffeine, marijuana, or nicotine.
• \. Requires current use of medications that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (Section 4.3.1).
• \. Any pending legal action that could affect participation or compliance in the trial.
• \. Is an employee of the Investigator or the trial site, with direct involvement in the proposed trial or other trials under the direction of the Investigator or trial site, or is a family member of the Investigator or an employee.

Sponsors & Collaborators

• Orexo AB: lead

Study Sites (21)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

North County Clinical Research

Oceanside, California, 92054, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

Wetlin Research Associates, Inc

San Diego, California, 92120, United States

Location

Humanity Clinical Research

Pembroke Pines, Florida, 33024, United States

Location

Southern Illinois Associates LLC

Glen Carbon, Illinois, 62034, United States

Location

Otrimed Clinical Research

Edgewood, Kentucky, 41017, United States

Location

Patient First Medical Clinic

Dearborn, Michigan, 48126, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

Dr. Vando Medical Services PC

The Bronx, New York, 10466, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

North Star Medical Research

Middleburg Heights, Ohio, 44130, United States

Location

Neuro-Behavioral Clinical Research Center

North Canton, Ohio, 44720, United States

Location

CincyScience

West Chester, Ohio, 45069, United States

Location

Pahl Pharmaceuticals Professions

Oklahoma City, Oklahoma, 73112, United States

Location

Thalia Medical Center

Haverford, Pennsylvania, 19041, United States

Location

MD Medical Management

Kingston, Pennsylvania, 18704, United States

Location

Medically Assisted Recovery Service

Philadelphia, Pennsylvania, 19116, United States

Location

Institute of Addiction Medicine

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The frequent number of site visits, interactions with the Investigators and site staff, and the general level of caregiving was elevated in comparison to the routine care provided outside of a randomized and controlled clinical trial. The design of this study may not have been optimal for testing this digital therapeutic in this population and may be considered a limitation to be avoided in future clinical studies of OXD01.

Results Point of Contact

• Title: David Capano
• Organization: Orexo US, Inc.

david.capano@orexo.com

9085079909

Study Officials

• David Capano, PharmD

  Orexo US, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 1, 2021
• Study Start: June 30, 2021
• Primary Completion: April 12, 2023
• Study Completion: May 10, 2023
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)