Safety and Tolerability Study of medicinal snuff.

• Conditions: icotine addiction; MedDRA version: 13.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2011-001764-21-SE
• Lead Sponsor: Magle AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>To assess the degree of saliva cotinine substitution with Nicachet 4 mg nicotine powder in pouch during smoking abstinence.<br>;Primary end point(s): Oral Saftey and Tolerability.;Timepoint(s) of evaluation of this end point: 45 days/6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Smoking abstinense;Timepoint(s) of evaluation of this end point: 45 days/6 weeks