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Behavioural Intervention
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of 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
No Placebo-Only Group
Summary
This trial is testing a new digital therapy tool called OXD01 along with standard medication to help patients with opioid addiction. The goal is to see if this combination can better reduce opioid use compared to medication alone. The digital tool provides therapy sessions through devices to support mental health.
Eligible Conditions
- Opioid Use Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 6 to week 25
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 6 to week 25
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change of Opioid use
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Orexo ABLead Sponsor
6 Previous Clinical Trials
1,793 Total Patients Enrolled