Smoking CessationPhase 2NCT05066724
Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
A Phase 2 study testing Centanafadine in people with Smoking Cessation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Centanafadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2021to 31 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed the informed consent form (ICF) and is able to read and understand the information provided in the ICF.
- Smokers 21 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
- Has an expired air carbon monoxide (CO) reading of at least 10 ppm at screening.
- At screening, express a desire to quit smoking within the next 30 days.
- Body mass index (BMI) of 18 to 40 kg/m2, inclusive at screening.
- Willing and able to comply with the requirements of the study.
- Owns a smartphone with text message and data capabilities compatible with necessary surveys.
Who cannot join
- Participants of childbearing potential (CBP) who are breastfeeding and/or have a positive pregnancy test result.
- Participant presenting with, or having a history of, uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure > 95 mmHg) or symptomatic hypotension.
- Participants with known ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, coronary artery bypass surgery, or other serious cardiac problems that would place him/her at increased vulnerability to the sympathomimetic effects of stimulant medication.
- History of seizures (after the age of 17 years).
- Participants of CBP or sexually active participants unless they agree to practice 2 different methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of Investigation Medicinal Product (IMP) for participants of CBP, and 30 days after the last dose of IMP for participants with partners who are of CBP. Unless the participant is sterile (i.e., participants who have had a bilateral oophorectomy or hysterectomy or who have been postmenopausal for at least 12 consecutive months; or participants who have had a bilateral orchidectomy) or remains abstinent, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pills, birth control injection, birth control implant, birth control patch, condom with spermicide, or sponge with spermicide. Participants who do not agree to refrain from donating sperm from screening through 30 days after the last dose of IMP.
- Participant has a history of dermatologic adverse reactions secondary to any drug exposure or any active/uncontrolled dermatologic disease.
Show all 16Show fewer
- Currently taking antidepressants (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), Tricyclic antidepressants (TCAs), or monoamine oxidase inhibitors (MAOIs)), antipsychotics (such as butyrophenones, thioxanthenes, atypical antipsychotics or other heterocyclics), benzodiazepines, hypnotics, or medications that prolong corrected QT Interval (QTc). MAOI's taken within 30 days of screening.
- Screening (Visit 1) or Baseline (Visit 2) Columbia-Suicide Severity Rating Scale (C-SSRS) score greater than 0 (any answer "Yes") for the SUICIDAL IDEATION section or greater than 0 for the SUICIDAL BEHAVIOR section (any answer "Yes").
- Substance use disorder within 12 months prior to screening.
- Participants that have a positive alcohol test (via breathalyzer or blood), a positive drug screen for illicit drugs (Table 6.3.5) at screening or baseline.
- Participants who test positive for marijuana at screening may be enrolled if they have no evidence of a substance use disorder and if they agree to refrain from use for the duration of the trial.
- Any participant who has any other medical or physical condition(s) that, in the opinion of the investigator, may prevent the participant from completing the trial or would go against the participant's best interest with participation in the trial. This would include any significant illness or unstable medical condition that could lead to difficulty complying with the protocol.
- Participants with abnormal laboratory tests, vital sign results, or ECG findings which in the investigator's judgment are medically significant and that would impact the safety of the participant or the interpretation of the trial results.
- Participants with a history of prior exposure to centanafadine.
- Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black \& Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy, or other smoking cessation treatments (e.g., bupropion as Zyban, or varenicline) within 14 days of screening.
- Participants who participated in a clinical trial and were exposed to interventional trial medication within the last 30 days prior to screening or who participated in more than 2 interventional clinical trials within the past year.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rose Research Center
Charlotte, North Carolina, 28262
Rose Research Center
Raleigh, North Carolina, 27617
About this study
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.
Read the 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
- Being tested
- Centanafadine
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentanafadineDrug
400 mg total daily dose Centanafadine Sustained Release, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Centanafadine | Experimental | 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. Receives: Drug: Centanafadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Continuous Smoking Abstinence Rate
Participants were considered abstinent from combustible cigarettes if the participant self-reported tobacco abstinence (no cigarette smoking, not even a puff) assessed by responses to daily messages throughout Weeks 4-7. Any participants lost to follow-up after receiving the investigational product, or who have smoked during Weeks 4-7 were counted as non-abstinent. The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
Measured: Weeks 4 to 7
Percentage of Participants With Continuous Smoking Abstinence Rate Determined Based on Expired Air Carbon Monoxide (CO) Reading Assessed Using the Vitalograph Breath CO Monitor
Participants were considered abstinent from combustible cigarettes if the participants had an exhaled CO level of less than 5 parts per million (ppm) measured using the Vitalograph Breath CO monitor. Participants with actual data that they were smoking (CO value ≥ 5 ppm or any smoking record in self-report) were counted as non-abstinent The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
Measured: Weeks 4 to 7
Secondary outcomes (1)
Percentage of Participants With Nausea
Nausea was only considered when it was a treatment-emergent adverse event (TEAE). A TEAE is defined as an adverse event (AE) which starts after start of first IMP or an AE continues from baseline of the specific corresponding duration and was serious, trial drug-related or results in death, discontinuation, interruption or reduction of IMP.
Measured: From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start15 Sep 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jed E Rose, Ph.D., Principal investigator, Rose Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066724
- Sponsor's protocol ID
- 405-201-00055
- Status last verified
- May 2025
- First submitted
- 23 Sep 2021
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Centanafadine SR as a Potential Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT05066724
- Acronym / sponsor ID
- 405-201-00055
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Centanafadine | Experimental | Drug: CentanafadineParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Has signed the informed consent form (ICF) and is able to read and understand the information provided in the ICF.
- Smokers 21 to 65 years of age (inclusive) at screening.
- Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
- Has an expired air carbon monoxide (CO) reading of at least 10 ppm at screening.
- At screening, express a desire to quit smoking within the next 30 days.
Key exclusion criteria (16 listed)
- Participants of childbearing potential (CBP) who are breastfeeding and/or have a positive pregnancy test result.
- Participant presenting with, or having a history of, uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure > 95 mmHg) or symptomatic hypotension.
- Participants with known ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, coronary artery bypass surgery, or other serious cardiac problems that would place him/her at increased vulnerability to the sympathomimetic effects of stimulant medication.
- History of seizures (after the age of 17 years).
- Participants of CBP or sexually active participants unless they agree to practice 2 different methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of Investigation Medicinal Product (IMP) for participants of CBP, and 30 days after the last dose of IMP for participants with partners who are of CBP. Unless the participant is sterile (i.e., participants who have had a bilateral oophorectomy or hysterectomy or who have been postmenopausal for at least 12 consecutive months; or participants who have had a bilateral orchidectomy) or remains abstinent, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pills, birth control injection, birth control implant, birth control patch, condom with spermicide, or sponge with spermicide. Participants who do not agree to refrain from donating sperm from screening through 30 days after the last dose of IMP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centanafadine400 mg total daily dose Centanafadine Sustained Release, oral tablets | Drug | Centanafadine |
Primary outcome
Percentage of Participants With a Continuous Smoking Abstinence Rate
Time frame: Weeks 4 to 7
Participants were considered abstinent from combustible cigarettes if the participant self-reported tobacco abstinence (no cigarette smoking, not even a puff) assessed by responses to daily messages throughout Weeks 4-7. Any participants lost to follow-up after receiving the investigational product, or who have smoked during Weeks 4-7 were counted as non-abstinent. The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
Percentage of Participants With Continuous Smoking Abstinence Rate Determined Based on Expired Air Carbon Monoxide (CO) Reading Assessed Using the Vitalograph Breath CO Monitor
Time frame: Weeks 4 to 7
Participants were considered abstinent from combustible cigarettes if the participants had an exhaled CO level of less than 5 parts per million (ppm) measured using the Vitalograph Breath CO monitor. Participants with actual data that they were smoking (CO value ≥ 5 ppm or any smoking record in self-report) were counted as non-abstinent The binomial confidence interval was based on normal approximation. If the number of abstinent or the number of non-abstinent ≤ 5, exact method was used.
1 secondary outcome
Percentage of Participants With Nausea
Time frame: From first dose of study drug to 7 days after receiving last dose (Up to Week 8)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed E Rose, Ph.D. principal investigator
Rose Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Centanafadine in people with Smoking Cessation, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Continuous Smoking Abstinence Rate (time frame: Weeks 4 to 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.