Nicotine addiction MedDRA version: 13.1 Level: PT Classification code 10053325 Term: Smoking cessation therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Nicachet
Product Code: 24:2009/517291
Pharmaceutical Form: Oromucosal powder in pouch
INN or Proposed INN: Nicotine
CAS Number: 54-11-5
Current Sponsor code: MA NS 11
Other descriptive n
Sponsors
Magle AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adult male and female smokers, 18-50 years, will be recruited using an advertisement in the local newspaper. Following a telephone interview to evaluate eligibility, potential participants are invited to a screening visit. The potential participants will then submit a Health Declaration that will be checked by the responsible Investigator. In order to be enrolled in the study subjects have to • be aged 18-50 years • be smoking >7 cigarettes per day • having smoked for >2 years • be motivated to stop smoking and to comply with the protocol • be able to understand written and spoken Swedish language • sign a written informed consent • show a score of >3 on the Fagerström Tolerance Questionnaire on Nicotine Dependence (FTQ) • not participate in any other clinical trial The FTQ measures nicotine dependence in tobacco smokers on a scale of 0 to 11. 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 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subjects showing the following criteria will be excluded: • symptoms from the oral mucosa, • cardiovascular disease (myocardial infarction within the preceding 3 months), • pregnancy • breast feeding • on psychotropic medication • abuse of alcohol or illegal drugs within the last 6 months • use of snuff or NRT products. • participation in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of Nicachet 4 mg nicotine powder in pouch on the oral mucosa over a 42-day smoke-free period.;Secondary Objective: To assess the efficacy of Nicachet 4 mg nicotine powder in pouch on abstinence from smoking during a 42-day smoke-free period. To assess the degree of saliva cotinine substitution with Nicachet 4 mg nicotine powder in pouch during smoking abstinence. ;Primary end point(s): Oral Saftey and Tolerability.;Timepoint(s) of evaluation of this end point: 45 days/6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Smoking abstinense;Timepoint(s) of evaluation of this end point: 45 days/6 weeks | — |
Countries
Sweden
Contacts
Public ContactPeter Fyhr
Magle AB
Outcome results
None listed