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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-7 weeks

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%

Study treatment Arm

Swallowed Capsules Cohort

Sprinkled Onto Applesauce Cohort

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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