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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

Study Summary

This trial will test whether a drug called centanafadine can help people quit smoking. It will last for 12 weeks, and participants will take 400mg of the drug per day.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Smoking Abstinence CO Reading
Smoking Abstinence Self Reported
Secondary outcome measures
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
245 Previous Clinical Trials
166,945 Total Patients Enrolled
Jed E Rose, Ph.D.Principal InvestigatorRose Research Center
12 Previous Clinical Trials
2,633 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
2021. "Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05066724.
~14 spots leftby Apr 2025
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