Smoking CessationPhase 2Zippy PDNCT07893158
A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
A Phase 2 study testing Nicotine Mint Oro Dispersible Tablet (Nic ODT) in people with Smoking Cessation and Nicotine Replacements Therapy, run by McNeil AB at 1 site in Canada.
Trial summary
The objective of the study is to evaluate the relief of momentary urge to smoke at pre-specified early post-dose time points after administration of Nic ODT compared to Placebo ODT. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Nicotine Replacements Therapy
- What is being tested?
- Nicotine Mint Oro Dispersible Tablet (Nic ODT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2026to 30 Oct 2027
- Phase
- Phase 2
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has signed and dated the informed consent document in person before participating in any study-specific procedures, indicating the participant has been informed of all pertinent aspects of the study.
- Absence of clinically relevant abnormalities as judged by the investigator on the basis of a detailed medical history, physical examination, oral health, vital signs, 12-lead electrocardiogram, and clinical laboratory tests.
- Has a Body Mass Index (BMI) between 18.5 and 34.9 kg/m2 with a total body weight ≥50.0 kg.
- Daily conventional cigarette smoker, smoking within 30 minutes of waking, who have been smoking for at least one-year preceding inclusion.
- Ability to fast for at least 12 hours before study drug administration and up to 4 hours after study drug administration and consume standard food.
- For females: Postmenopausal state or premenopausal/perimenopausal state or child bearing potential with an effective means of contraception during the study and for at least 30 days after the final dose of IP.
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- Males must be willing to utilize an acceptable form of birth control with spouse/partner during the study and for at least 30 days after the final dose of IP.
- Able to read and understand English.
- Is able to comprehend the requirements of the study (based upon clinical site personnel's assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified within the protocol.
Who cannot join
- Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the study.
- Female participants who are pregnant (as confirmed by a positive pregnancy test), breastfeeding, or planning to become pregnant during the study period will be excluded.
- Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV).
- Has a positive test for drugs of abuse and/or alcohol at screening and study check-in.
- Has hepatic impairment
- Has a history of clinically significant gastrointestinal surgery that, in the opinion of the Investigator, may affect the safety of the participant.
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- Clinically significant medical conditions that are unstable or uncontrolled and may interfere with a participant's participation in the study in the opinion of the medically qualified investigator.
- History of alcoholism or substance abuse (including marijuana), as judged by the Investigator, within 6 months preceding this study.
- History of epilepsy or seizures.
- Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction and any other conditions of the mucosal surface of the mouth that in the opinion of the investigator may affect IP absorption.
- Has the presence of a tongue piercing or a history of tongue piercing within 90 days prior to the Screening visit.
- Dosed with another investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the treatment visit, or participants who have received the last dose of IP more than 30 days or 5 half-lives (whichever is longer) prior to the treatment visit, but who are on an extended follow-up.
- Has pre-planned surgery, procedures, or personal commitments that would interfere with the conduct of the study.
- Is related to persons involved directly in the conduct of the study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees or contractors of the Sponsor or Kenvue subsidiaries, and their family).
- Reports difficulty fasting or consuming standardized meals.
- The participant, in the opinion of the PI/designee , is unlikely to comply with the protocol or is unsuitable to participate in the study due to any other reason.
- Use of other smoking cessation medications or aid(s) within 28 days before screening and during the study (e.g., NRT, buproprion, varenicline, cytisine, counselling, apps, acupuncture, or hypnosis).
- Use of any prescription or non-prescription medications within 7 days or 5 half-lives (whichever is longer) prior to first dose, and use of vitamins, dietary supplements, or herbal products within 7 days prior to administration.
- Uncontrolled hyperthyroidism or phaeochromocytoma.
- History of recent or unstable cardiovascular disease, a gastric or peptic ulcer, esophagitis, or diabetes not controlled by oral medication only.
- Other severe, acute or chronic, medical or psychiatric condition(s) or laboratory abnormality(ies) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Inflamax Research DBA Cliantha Research Limited - Ontario
Mississauga, Ontario, L4W 1V7
Patricia Couroux, pcouroux@cliantha.com
About this study
Official title: A Randomized, Double-Blind, Fasting, Pharmacodynamic Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
The objective of the study is to evaluate the relief of momentary urge to smoke at pre-specified early post-dose time points after administration of Nic ODT compared to Placebo ODT.
- Conditions
- Smoking Cessation, Nicotine Replacements Therapy
- Being tested
- Nicotine Mint Oro Dispersible Tablet (Nic ODT), Placebo Oro Dispersible Tablet (Placebo ODT)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Mint Oro Dispersible Tablet (Nic ODT)Drug
Nic ODT 2.0 mg, orally
Placebo Oro Dispersible Tablet (Placebo ODT)Drug
Placebo ODT, orally
| Study group | Role | What they receive |
|---|---|---|
| Nic ODT 2.0 mg | Experimental | Not described Receives: Drug: Nicotine Mint Oro Dispersible Tablet (Nic ODT) |
| Placebo ODT | Placebo comparator | Not described Receives: Drug: Placebo Oro Dispersible Tablet (Placebo ODT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) score change
The change from baseline in momentary urge-to-smoke VAS score (scale of 0: no urge to smoke to 100: extremely high urge to smoke).
Baseline is defined as the mean of the three pre-dose VAS assessments collected at -5, -3, and -1 minute prior to treatment administration.
Measured: 2 minutes, 1 minute, 0.75 minutes (45 seconds) and 0.5 minutes (30 seconds) after start of IP administration.
Secondary outcomes (4)
Visual Analog Scale (VAS) score change
The change from baseline in momentary urge-to-smoke VAS score (scale of 0: no urge to smoke to 100: extremely high urge to smoke).
Baseline is defined as the mean of the three pre-dose VAS assessments collected at -5, -3, and -1 minute prior to treatment administration.
Measured: At 0.25 (15 seconds), 3, 5, and 10 minutes after start of administration.
Occurrence of self-reported and observed AEs
Measured: From signing of informed consent through study completion, up to 46 days
The time from administration to the sensation of disintegration of Nic ODT.
Time from start of Nic ODT administration (tablet placed on the tongue) to the participant's first signal of perceived onset of disintegration.
Measured: Day 1, after completion of PD assessments: from start of Nic ODT administration up to approximately 5 minutes
The time for total disintegration of Nic ODT.
Time from start of Nic ODT administration to the participant's signal of complete disintegration, confirmed by mouth check.
Measured: Day 1, after completion of PD assessments: from start of Nic ODT administration up to approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start5 Oct 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893158
- Sponsor's protocol ID
- CS2025SC100297
- Acronym
- Zippy PD
- Status last verified
- 19 Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No