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Auvelity for Opioid Use Disorder

Phase 1 & 2
Recruiting
Led By Frederick G Moeller
Research Sponsored by Virginia Commonwealth University
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 during each pk study visit from visit start to end, up to approximately 8 hours
Awards & highlights

Summary

This trial aims to study how a new drug impacts safety & effectiveness for opioid use disorder (OUD) patients on buprenorphine treatment.

Who is the study for?
This trial is for adults aged 18-65 with moderate to severe Opioid Use Disorder (OUD) who are currently on stable buprenorphine treatment. They must have a positive urine test for buprenorphine, mild depression symptoms or greater, and agree to use contraception if applicable. Excluded are those on certain medications like antidepressants, with serious health issues, significant heart abnormalities, or recent suicidal behavior.Check my eligibility
What is being tested?
The study tests the combination of Dextromethorphan and Bupropion (Auvelity) against a placebo in people with OUD. It aims to assess drug interactions and early signs of effectiveness in reducing negative feelings, cravings, and withdrawal symptoms associated with opioid addiction.See study design
What are the potential side effects?
Potential side effects may include reactions similar to those seen with buprenorphine or dextromethorphan use such as gastrointestinal distress, mood changes, dizziness or sedation. Specific side effects related to Auvelity will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during each pk study visit from visit start to end, up to approximately 8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and during each pk study visit from visit start to end, up to approximately 8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety- as measured by Adverse events
Safety- as measured by blood pressure
Safety- as measured by heart rate
+2 more
Secondary outcome measures
Buprenorphine PK

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AuvelityExperimental Treatment1 Intervention
Orally-administered combination of dextromethorphan with Bupropion (trade name Auvelity)
Group II: PlaceboPlacebo Group1 Intervention
Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
702 Previous Clinical Trials
22,886,771 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,565 Total Patients Enrolled
Frederick G MoellerPrincipal InvestigatorVirginia Commonwealth University
~6 spots leftby Jan 2025