Clinical trial for Smoking Cessation
Official title A Study of Nicotine Orodispersible Tablet on Craving Relief of Male and Female Smoker Volunteers
ClinicalTrials.gov ID: NCT07893158
What this study is testing
What is Nicotine Mint Oro Dispersible Tablet (Nic ODT)?
This is an investigational nicotine tablet being studied to help people stop smoking. It is designed to release nicotine through the mouth lining to help reduce the urge to smoke.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a nicotine tablet works better than a pretend tablet. It looks at how well it stops the urge to smoke right after taking it.
- Who it's for
- You may be able to join if you are a smoker who wants to quit.
- What's involved
- You would take a small tablet by mouth. You would report how strong your urge to smoke is at set times.
- Time commitment
- The study involves short visits to check your cravings after taking the tablet.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Has signed and dated the informed consent document in person before participating in any study-specific procedures, indicating the participant has...
- Absence of clinically relevant abnormalities as judged by the investigator on the basis of a detailed medical history, physical examination, oral...
- 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.
You likely can't join 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...
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Mississauga, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mississauga, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.