A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers

NCT07893158 | Recruiting Phase 2

• 1 other identifier: CS2025SC100297
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Nicotine Replacements Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At 0.25 (15 seconds), 3, 5, and 10 minutes after start of administration.

• Occurrence of self-reported and observed AEs

  From signing of informed consent through study completion, up to 46 days

• The time from administration to the sensation of disintegration of Nic ODT.

  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.

  Day 1, after completion of PD assessments: from start of Nic ODT administration up to approximately 5 minutes

Study Arms (2)

Nic ODT 2.0 mg

EXPERIMENTAL

Drug: Nicotine Mint Oro Dispersible Tablet (Nic ODT)

Placebo ODT

PLACEBO COMPARATOR

Drug: Placebo Oro Dispersible Tablet (Placebo ODT)

Interventions

Nicotine Mint Oro Dispersible Tablet (Nic ODT) DRUG

Nic ODT 2.0 mg, orally

Nic ODT 2.0 mg

Placebo Oro Dispersible Tablet (Placebo ODT) DRUG

Placebo ODT, orally

Placebo ODT

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Inflamax Research DBA Cliantha Research Limited - Ontario

Mississauga, Ontario, L4W 1V7, Canada

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Kenvue GCO Clinical Mailbox

CONTACT

18779295131; KenvueClinical_KV@kenvue.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 23, 2026
• Study Start: October 5, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10-19

Locations

CA (1)