Tobacco Dependence
Conditions
Interventions
Trade Name: Nicorette Pepparmint 1 mg/spray, munhålespray, lösning
Product Name: Nicorette Pepparmint 1 mg/spray
Pharmaceutical Form: Oromucosal spray, suspension
INN or Proposed INN: Nicotine
CAS Num
Sponsors
McNeil AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subject between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as judged by the Investigator on the basis of a detailed medical history, physical examination, blood pressure, and pulse rate measurements. The responsible Investigator may request additional investigations or analyses if necessary. 2. Smoking of at least 10 cigarettes daily during at least one year preceding inclusion. 3. Smoking within 30 minutes of waking up. 4. Has a Body Mass Index between 17.5 and 32.0 kg/m2 with a total body weight > 50 kg. 5. Females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum Follicle Stimulating Hormone (FSH) level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected, implanted, transdermal, hormonal contraceptives, vaginal contraceptive ring, intrauterine device, or status after operative sterilization) during the study and 30 days thereafter, single male partner who has had a vasectomy, or abstinence from heterosexual intercourse, during the study and 30 days thereafter. 6. Males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study and 30 days thereafter. 7. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. 8. Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures specified in the protocol. 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 64 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of medications other than contraceptives specified in Inclusion Criterion 5 or occasional use of other medications approved by the Investigator. 2. Known sensitivity to any ingredient of the studied formulations. 3. Females: pregnancy and/or breastfeeding. 4. History of alcoholism or substance abuse, as judged by the Investigator, within the past 6 months preceding this study. 5. Treatment with an investigational drug, other than those described in this protocol, within 3 months preceding this study and until the last treatment visit of the study. 6. Use of drugs indicated for smoking cessation or history of a quit attempt within than 3 months preceding the screening visit. 7. Pathological oral status interfering with absorptive function of the oral cavity. 8. Relationship to persons involved directly with the conduct of the study (i.e., PI; sub Investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the families of each).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • to compare ONS, two sprays of 1 mg nicotine, and one Tabex tablet of 1.5 mg cytisine after 12 hours of overnight abstinence with respect to reduction of urges to smoke during the first 5 minutes after start of treatment, and • to compare the two treatments with respect to the urges-to-smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline. ;Primary end point(s): The primary study endpoints are the mean average score changes from baseline up to 30, 45, and 60 seconds, 3 and 5 minutes and, furthermore, the mean reduction in urges to smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline.;Timepoint(s) of evaluation of this end point: Pre-dose and 30, 45, and 60 seconds, 3, and 5 minutes after treatment is given.;Secondary Objective: • to compare the study treatments with respect to the estimated time to a 25%, 50%, 75%, and 90% reduction of the baseline urges-to-smoke score, • to compare the proportion of subjects reaching 25%, 50%, 75%, and 90% reduction of the baseline urges to smoke within 30, 45, and 60 seconds, 3, 5, and 10 minutes for the study treatments, • to describe the urges-to-smoke profile of the study treatments during 2 hours after dose, • to compare the study treatments with respect to the urges-to-smoke scores at 30, 45, and 60 seconds, 3 and 5 minutes vs. baseline, and during the first 5 minutes, in the fraction of the subjects reporting “tough” baseline urges to smoke, • to compare the study treatments with respect to negative affect related nicotine withdrawal symptoms (depressed mood, irritability, anxiety, and difficulty concentrating), • to evaluate preference of the study treatments with respect to craving relief, • to evaluate tolerability and safety of the study treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include the times to 25%, 50%, 75%, and 90% reduction of baseline urges-to-smoke scores, the proportion of subjects reaching 25%, 50% 75%, and 90% reduction of the baseline urges to smoke within 30, 45, and 60 seconds, and 3, 5, and 10 minutes, depressed mood, irritability, anxiety and difficulty concentrating, preference of study treatments with respect to craving relief, and observed or spontaneously reported AEs.;Timepoint(s) of evaluation of this end point: 30, 45, and 60 seconds, 3, 5 and 10 minutes after treatment is given. | — |
Countries
Sweden
Contacts
Public ContactGlobal Regulatory Affairs OTC Hsbg
McNeil AB
Outcome results
None listed