Tobacco dependence
Conditions
Interventions
Product Name: Oromucosal Nicotine Spray
Product Code: ONS
Pharmaceutical Form: Oromucosal spray
CAS Number: 54115
Other descriptive name: Nicotine
Concentration unit: mg/ml milligram(s)/millilitre
Con
Sponsors
McNeil AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy male or female subjects between the ages of 19 and 55 years, inclusive. Health is defined as the absence of clinically relevant abnormalities as identified by a detailed medical history, a physical examination, and blood pressure, pulse rate and hemoglobin measurements, as judged by the investigator or an authorized physician. The responsible physician may order additional investigations or analyses if necessary. 2.Smoking within 30 minutes of waking up. 3.Smoking of at least 10 cigarettes daily during at least one year preceding inclusion. 4.For females: Postmenopausal state (absence of menstrual discharge for at least two years and a serum FSH level exceeding 30 IU/L) or premenopausal/perimenopausal state with an effective means of contraception (oral, injected or implanted hormonal contraceptives, intrauterine device, or status after operative sterilization), or declared absence of sexual contact during the study. 5.Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight >= 50.0 kg. 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. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the investigator or an authorized study physician, increases the risk associated with study participation or interfere with the interpretability of study results. 2.Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal, state with insufficient contraception as specified under Inclusion Criteria. 3.History of regular alcohol consumption in the 6 months before screening, exceeding weekly limits of 2 L of wine or 5 L of beer or 0.6 L of spirits for females, and 3 L of wine or 7.5 L of beer or 0.9 L of spirits for males. The investigator may lower these limits if a subject consumes different types of alcoholic beverages. 4.Use of other NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before the screening visit. 5.Treatment with an investigational product, other than those described in this protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study. 6.Pathological oral status interfering with normal muscular, sensory, or absorptive function of the oral cavity. 7.Prior regular use of nicotine mouthspray and/or nicotine lozenge. 8.Relationship to persons involved directly with the conduct of the study (i.e,, principal investigator; subinvestigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson & Johnson subsidiaries; and the family of each).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary study endpoints are the area under the urges to smoke-vs.-time curve (AUC) from start of administration until 5 minutes thereafter, AUC5min, the AUC from the start of administration until 3 minutes thereafter, AUC3min, and the AUC from the start of administration until 1 minute thereafter, AUC1min. ;Main Objective: The primary objectives of this study are: •to compare ONS (two sprays of 1 mg nicotine) and NiQuitin lozenge 2 mg after 5 hours of witnessed abstinence with respect to urges to smoke during the first 5 minutes after start of treatment., and •to compare ONS (two sprays of 1 mg nicotine) and NiQuitin lozenge 4 mg after 5 hours of witnessed abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. ;Secondary Objective: Secondary objectives are: •to compare the study treatments with respect to the 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 1, 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 evaluate acceptability of the study treatments, •to evaluate tolerability and safety of the study treatments. | — |
Countries
Sweden
Outcome results
None listed