Healthy Volunteers between 19 and 60 years of age motivated and willing to quit smoking. MedDRA version: 20.0 Level: PT Classification code 10057852 Term: Nicotine dependence System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Nicorette Freshfruit Gum, 4 mg
Product Name: Nicorette Freshfruit
Pharmaceutical Form: Medicated chewing-gum
INN or Proposed INN: NICOTINE RESINATE
Other descriptive name: NICOTINE RESINAT
Sponsors
McNeil AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Motivated and willing to quit smoking. 2. Healthy male or female subjects between the ages of 19 and 60 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the investigator based on a detailed medical history, physical examination, blood pressure and pulse rate measurements. The responsible investigator may request additional investigations or analyses to consider Nicorette Freshfruit label warnings and precautions if necessary. 3. Smoking more than 20 cigarettes per day regularly during at least one year prior to inclusion. 4. For females: Postmenopausal state (absence of menstrual discharge for at least one year and or premenopausal/perimenopausal state with an effective means of contraception (Section 9.3.4) during the study and 30 days thereafter. 5. For males: No pregnant spouse or partner at screening/baseline and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and 30 days thereafter. 6. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. 7. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol, and able and willing to use an e-diary during the study period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study. 1. Hypersensitivity to the ingredients/components of the investigational products. 2. Current use of any contra-indicated medicine according to label for Nicorette Freshfruit. 3. Females: Pregnancy and/or breast-feeding. 4. History of alcoholism or substance abuse in the six months before screening/baseline, as judged by the Investigator. 5. Treatment with an investigational drug within 3 months preceding the first dose of study treatment. 6. Use of nicotine Chewing Gum the last 6 months. 7. Use of other therapies for smoking cessation the last 3 months, including, but not limited to NRT, varenicline, and cytisine. 8. Current use of e-cigarettes. 9. Preplanned surgery or procedures during the study period, if this may interfere with the conduct of the study. 10. Subjects ineligible to participate based on the “warning and precautions” section of the label, based on the judgement of the Investigator. 11. Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson (J&J) subsidiaries; and the families of each). 12. Member of the same household as another participant in the study. 13. Subjects working night shifts during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To better understand the pharmacodynamics of the nicotine gum, the current study will investigate the benefits over a placebo gum with regards to withdrawal symptoms, including urges to smoke, and the effect on the willpower to quit smoking and/or to resist a cigarette. Primary objective: To evaluate the effect of 4 mg nicotine chewing gum on participants’ perceived relief of overall withdrawal symptoms including urges to smoke, compared to placebo, over the first 2 treatment days. ;Secondary Objective: Secondary objectives: To evaluate the effect of 4 mg nicotine chewing gum on: 1. Participants’ relief of overall withdrawal symptoms, compared to placebo, over Days 3 to 7 and Days 8 to 14, respectively. 2. Participants’ relief of individual withdrawal symptoms, compared to placebo, over Days 1 and 2, Days 3 to 7 and Days 8 to 14, respectively. 3. Participants’ change in perceived self-efficacy in quitting smoking, compared to placebo, at the Week 1 visit. 4. Participants’ perceived willpower to quit smoking, relative to placebo, at Days 2, 7 and 14, respectively. 5. Participants’ perceived willpower to resist a cigarette, relative to placebo, at Days 2, 7 and 14. 6. CO-verified continuous smoking abstinence, relative to placebo, over 1 and 2 weeks. In addition, the tolerability and safety and compliance with the study treatments will be evaluated.;Primary end point(s): Mean of daily self-assessed VAS ratings of overall relief of withdrawal symptoms over Days 1 and 2. ;Timepoint(s) of evaluation of this end point: Days 1 and 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints 1. Mean of daily self-assessed VAS ratings of relief of overall withdrawal symptoms over Days 3 to 7 and Days 8 to 14, respectively. 2. Mean of daily self-assessed VAS ratings of relief of individual withdrawal symptoms (urge to smoke, depressed mood, irritability, frustration, restlessness, increased appetite, stress, difficulty concentrating) over Days 1 and 2, Days 3 to 7, and Days 8 to 14, respectively. 3. Perceived change in self-efficacy in quitting smoking on a 7-grade scale (1 = much less confident; 7 = much more confident) at the Week 1 visit. 4. Self-assessed ratings of change in willpower to quit smoking on a 7-grade categorical scale (1 = much weaker willpower; 7 = much stronger willpower) after 2, 7 and 14 days, respectively. 5. Self-assessed ratings of change in willpower to resist a cigarette on a 7-grade categorical scale (1 = much weaker willpower; 7 = much stronger willpower) after 2, 7 and 14 days, respectively. 6. Daily recordings of number of cigarettes smoked. 7. Daily recordings of use of study treatment. 8. Self-reported and CO-verified (<10 ppm) smoking abstinence since start of study, evaluated at the Week 1 and Week 2 (End of study) visits.;Timepoint(s) of evaluation of this end point: Day 1, 2, 7, 8 and 14; Visit: Week 1 and 2 | — |
Countries
Poland
Contacts
Public ContactGlobal Regulatory Affairs OTC Hsbg
McNeil AB
Outcome results
None listed