NCT05066724

Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will explore the efficacy and tolerability of centanafadine at a dose of 400 mg per day of centanafadine in promoting smoking abstinence in adult smokers seeking to quit.

Detailed description

This single-group, open-label study of 50 participants will explore the potential of centanafadine in promoting smoking abstinence in adult smokers seeking to quit. The efficacy and tolerability of centanafadine at a dose of 400 mg total daily dose (TDD) (200 mg twice a day (BID)) approximately 4 to 6 hours apart (during a 7-week treatment period) will be compared with a benchmark of abstinence based on historical data from clinical trials of varenicline, viewed as the most efficacious pharmacotherapy currently approved by the FDA.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Centanafadine	400 mg total daily dose Centanafadine Sustained Release, oral tablets

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2021-10-04
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study