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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine for Smoking Cessation

Phase 2
Waitlist Available
Led By Jed E Rose, Ph.D.
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
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 4-7 weeks
Awards & highlights

Summary

This trial is testing centanafadine, a medication taken regularly, to help adult smokers quit. The study aims to see if this medication can reduce cravings or make quitting easier.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-7 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Smoking Abstinence CO Reading
Smoking Abstinence Self Reported
Secondary study objectives
REDUCTION IN INCIDENCE OF NAUSEA

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT04081363
14%
Vessel Puncture Site Bruise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Swallowed Capsules Cohort
Sprinkled Onto Applesauce Cohort

Trial Design

1Treatment groups
Experimental Treatment
Group I: CentanafadineExperimental Treatment1 Intervention
Participants will receive centanafadine sustained release (SR) tablets, orally at a TDD of 400 milligrams (mg), administered as 200 mg doses, BID, approximately 4 to 6 hours apart, for a total of 7 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Centanafadine
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
264 Previous Clinical Trials
170,030 Total Patients Enrolled
Jed E Rose, Ph.D.Principal InvestigatorRose Research Center
12 Previous Clinical Trials
2,633 Total Patients Enrolled
~12 spots leftby Sep 2025
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