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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

Study 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?

National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,713 Total Patients Enrolled
Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,885,027 Total Patients Enrolled
Frederick G MoellerPrincipal InvestigatorVirginia Commonwealth University

Frequently Asked Questions

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

Is eligibility for this investigation restricted to those under 25 years of age?

"This medical trial is inviting adults aged between 18 and 65 to participate."

Answered by AI

Are there presently any opportunities to participate in this experiment?

"Affirmative. Per the information available on clinicaltrials.gov, this study is actively seeking participants; first listed in September 18th 2023 and updated lastly on that same day. The trial requires 18 people to be recruited from a single medical centre."

Answered by AI

To which demographics does this research offer access?

"This clinical trial is recruiting 18 individuals with opioid use disorder that fall within the ages of eighteen and sixty-five. To be considered, a male or female applicant must have DSM-5 criteria for OUD of at least moderate severity, currently engaged in MOUD treatment for two weeks before screening, tested positive on their urine drug screen during screening to document buprenorphine usage, registered a score of mild or greater (>6) on the Quick Inventory Depressive Symptomatology (16-Item), females must not be pregnant/lactating and those who are childbearing potential must agree to practice an acceptable form of"

Answered by AI

How many participants have been accepted to take part in this experiment?

"Affirmative. Information on clinicaltrials.gov demonstrates that this medical experiment is currently recruiting; the initial posting was made on September 18th and it has undergone a recent update for the same date. This study necessitates 18 participants from one particular location to continue its research endeavours."

Answered by AI

Who else is applying?

What site did they apply to?
CARI Research Clinic- VCU Institute for Drug and Alcohol Studies
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have been. Treatment years.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
2023. "Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05976646.
All > Addiction
~10 spots leftby Jan 2025
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