NCT05976646

Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion

Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion (AUVELITY) as an Adjunctive Treatment for Buprenorphine/Naloxone for Opioid Use Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. The compound to be studied in this protocol will be a pre-configured combination of 45mg dextromethorphan with 105 mg Bupropion (AuvelityTM, hereafter referred as Auvelity). Notably, other NMDA receptor antagonists such as ketamine have also been shown to rapidly improve mood and reduce suicidality. OUD has also been linked to histories of trauma and syndromes of negative mood, where opioid use in many individuals was initially motivated by a desire to alleviate a negative mood state. Lastly, using the NIDA Phenotyping Battery, our group has also found negative emotionality to be part of a constellation of neurofunctional domains that are associated with SUD severity. Taken together, providing AUVELITY as an adjunctive treatment to buprenorphine could be an avenue to target crucial underlying mechanisms of OUD and improve OUD treatment outcomes.

Conditions

• Addiction
• Opioid Use
• Substance Use Disorders
• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Placebo	Subjects who are randomized to placebo will receive identical capsules to the test product at the same time periods noted above, administered orally.
DRUG	Auvelity	Orally-administered combination of 45 mg dextromethorphan with 105 mg Bupropion (trade name Auvelity). Auvelity will initially be administered orally once daily for three days. After 3 days on once daily AUVELITY, the participants will begin taking AUVELITY twice daily for 4 additional days as recommended in the FDA-approved prescribing information.

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2023-08-04
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study