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Behavioural Intervention

OXD01 digital therapy for Opioid Use Disorder

N/A
Waitlist Available
Research Sponsored by Orexo AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 6 to week 25
Awards & highlights

Summary

This trial is testing whether a digital therapeutic called MODIA, when used with a standard treatment for opioid addiction called sublingual buprenorphine/naloxone, is more effective than sublingual buprenorphine/naloxone alone in reducing opioid use. The trial will enroll 400 participants who will be randomly assigned to receive either the combination treatment or sublingual buprenorphine/naloxone alone. The trial will last 24 weeks, and participants will be evaluated weekly for the first 4 weeks, then every other week from weeks 5-12, and then monthly from weeks 13-25.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 6 to week 25
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 6 to week 25 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change of Opioid use

Trial Design

2Treatment groups
Experimental Treatment
Group I: SL BUP/NAL SOC background therapyExperimental Treatment1 Intervention
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.
Group II: SL BUP/NAL + OXD01Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OXD01 digital therapy
2021
N/A
~440

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Who is running the clinical trial?

Orexo ABLead Sponsor
6 Previous Clinical Trials
1,793 Total Patients Enrolled
~109 spots leftby Jul 2025