Clinical trial NCT04948307: OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: digital therapy
cognitive behavioral therapy
CBT
Lead sponsor: Orexo AB
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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 urine drug screen (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 opioid use disorder (OUD). However, patients may not have optimal access to faceto-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.

Eligibility 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. Currently meets the criteria for moderate or severe opioid use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-V (Appendix B).
5. Has a positive UDS for opioids at screening that is consistent with their drug use history.
6. In good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
7. 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.
8. 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:

* 1. 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).

  2. 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.

  3. Used an investigational drug within 30 days or 5 half-lives (whichever is greater) prior to randomization.

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

  5. 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.

  6. Tongue piercing, or piercings in the mouth or oral deformities that may affect sublingual absorption, in the opinion of an Investigator.

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

  8. 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.

  9. 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.

  10. A current diagnosis, other than opioid use disorder, requiring chronic opioid treatment.

  11. 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.

  13. Requires current use of medications that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 (Section 4.3.1).

  14. Any pending legal action that could affect participation or compliance in the trial.

  15. 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.

Primary outcomes:
measure: change of Opioid use
timeFrame: from week 6 to week 25
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Oceanside
country: United States
facility: North County Clinical Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Wetlin Research Associates, Inc
state: California
city: Pembroke Pines
country: United States
facility: Humanity Clinical Research
state: Florida
city: Glen Carbon
country: United States
facility: Southern Illinois Associates LLC
state: Illinois
city: Edgewood
country: United States
facility: Otrimed Clinical Research
state: Kentucky
city: Dearborn
country: United States
facility: Patient First Medical Clinic
state: Michigan
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Bronx
country: United States
facility: Dr. Vando Medical Services PC
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research Center
state: Ohio
city: West Chester
country: United States
facility: CincyScience
state: Ohio
city: Oklahoma City
country: United States
facility: Pahl Pharmaceuticals Professions
state: Oklahoma
city: Haverford
country: United States
facility: Thalia Medical Center
state: Pennsylvania
city: Kingston
country: United States
facility: MD Medical Management
state: Pennsylvania
city: Philadelphia
country: United States
facility: Medically Assisted Recovery Service
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Institute of Addiction Medicine
state: Pennsylvania
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
Study officials:
References: