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Clinical Trial 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.

Clinical Trial Description

This single-group, open-label study of 50 subjects 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05066724
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact Derek Mercedes
Phone 7043502999
Email [email protected]
Status Recruiting
Phase Phase 2
Start date September 13, 2021
Completion date October 10, 2022

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