Auvelity for Opioid Use Disorder
Trial Summary
What is the purpose of this trial?
The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as antidepressants, antiepileptics, and CNS stimulants, at least two weeks before starting the study medication. If you are on these medications, you will need to discontinue them to participate.
What data supports the effectiveness of the drug combination of dextromethorphan and bupropion for opioid use disorder?
Is Auvelity (dextromethorphan and bupropion) generally safe for humans?
There is limited safety data available for the combination of dextromethorphan and bupropion in humans, but bupropion alone has been studied for smoking cessation and methamphetamine use disorder, showing some safety in those contexts. Further studies are needed to confirm the safety of the combination specifically for opioid use disorder.13567
How does the drug Auvelity differ from other treatments for opioid use disorder?
Auvelity is unique because it includes bupropion, which is known for its role in smoking cessation and depression treatment by affecting noradrenaline and dopamine levels in the brain. This mechanism might offer a novel approach for opioid use disorder, differing from traditional treatments that often focus on opioid receptor interactions.7891011
Research Team
Frederick G Moeller
Principal Investigator
Virginia Commonwealth University
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Auvelity or placebo as an adjunctive treatment to buprenorphine/naloxone for opioid use disorder
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator