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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

Study 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

Find a Location

Who is running the clinical trial?

Orexo ABLead Sponsor
6 Previous Clinical Trials
1,793 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have any open slots for participants in this experiment?

"Per the information available on clinicaltrials.gov, this medical experiment is actively accepting volunteers. The trial was initially publicised on June 30th 2021 and has undergone its most recent edit November 18th 2022."

Answered by AI

Are there any North-American medical centers conducting this experiment?

"The trial is accessible in twenty-one centres, from the Institute of Addiction Medicine located in Plymouth Meeting to the Neuro-Behavioral Clinical Research Center found in North Canton."

Answered by AI

How many participants are eligible for this research study?

"To complete this research trial, 400 eligible patients need to register. The study is available at the Institute of Addiction Medicine in Plymouth Meeting and Southern Illinois Associates LLC in Glen Carbon."

Answered by AI

Does this research include adults aged 55 and over?

"This clinical trial only allows patients aged between 18 and 65 to participate in the study due to its eligibility criteria."

Answered by AI

Would I qualify as a participant for this clinical research project?

"This medical trial is recruiting 400 individuals between the age of majority and 65 that are struggling with substance abuse. Furthermore, for inclusion in this experiment, it's essential that participants: exhibit no significant health irregularities as ascertained by screening; forego all buprenorphine products except those prescribed during the study; use OXD01 per guidance if chosen to be part of its group; have adequate audio-visual acuity and motor skills necessary to understand instructions and operate applications on the web; deliberately seek help for opioid dependency disorder (OUD); complete SL BUP/NAL induction such that physical withdrawal symptoms are minimized so they can"

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Thalia Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
2021. "OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948307.
~117 spots leftby Apr 2025
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