The intended indication for the drug under investigation is smoking relapse prevention. Tobacco smoking has been identified as the single largest preventable cause of morbidity and premature death in the developed world. The prevalence of smoking range from about 20 to 50 per cent in the developed countries and from a global perspective, tobacco smoking continues to increase. The study will be performed in smokers. MedDRA version: 9.1 Level: LLT Classification code 10056478 Term: Nicotine addic
Conditions
Interventions
Product Name: Niccine
Product Code: Niccine
Pharmaceutical Form: Injection*
Pharmaceutical form of the placebo: Injection*
Route of administration of the placebo: Intramuscular use
Sponsors
Independent Pharmaceutica AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cigarette smokers, smoking on average at least 10 cigarettes per day, has fewer than three months of abstinence in the past year and is motivated to quit. 2. Men or women, 25 to 50 years of age (inclusive). 3. Women of childbearing capacity must use a reliable contraceptive method, e.g. the double barrier method, an intra-uterine device or oral contraceptive. 4. Positive for exhaled carbon monoxide (CO), >5 ppm. 5. Healthy and with normal findings in the pre-study physical examination (as judged by the Investigator) 6. Has signed the Informed Consent Form 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. Pregnant and lactating female 2. Previous treatment with any nicotine vaccine 3. Vaccination with any other vaccine product from four weeks before first dose or planned vaccination until four weeks after the last vaccination with the investgational product. 4. Vaccination with any other medicinal product containing TT within two years prior to enrolment. 5. Concurrent use of any drug that may have a negative effect on the immune system (as judged by the investigator) 6. Use of antidepressant or antipsychotic drugs within six months prior to enrolment in the study 7. Concurrent use of any other nicotine containing product than cigarettes 8. Current diagnosis or a history of repeated depressive episodes or of anxiety disorders or psychosis. 9. Clinical diagnosis of moderate to severe asthma or COPD or emphysema. 10. Unstable heart disease (as judged by the Investigator). 11. Use of any smoking cessation drugs within six months of enrolment in the study. 12. Known hyper reactivity to previous vaccinations with TT. 13. Known or suspected allergy or hypersensitivity to any of the components in the investigational or reference products. 14. Suspected abuse or misuse of alcohol or any of the drugs tested for during screening. 15. Diseases with immunological etiology, e.g. autoimmune disorders. 16. History of cancer. 17. Positive serology for HIV and/or Hepatitis B and/or Hepatitis C. 18. Participation in another clinical study within three months prior to enrolment or during the present study. 19. If the Investigator, for any other reason, assesses that the Subject should not be included (e.g. planned travel, expected low compliance, expected withdrawal).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Safety Relapse prevention at six, nine and twelve months Point prevalence Nicotine withdrawal Exhaled carbon monoxide Immunogenicity of Niccine Time to first relapse Smoking habits (including compensatory smoking) Continouse abstinence Craving;Primary end point(s): The primary end point is to evaluate Niccines effect on preventing smoking relapses in Subjects that have recently quit smoking. Relapses will be assessed by smoking questionnaires.;Main Objective: The main objective of the study is to evaluate the efficacy of Niccine compared to placebo, on relapse prevention at twelve months after the first vaccination with the study drug. The objective will be explored following six intramuscular injections of the study drug in subjects who have recently quit smoking with the smoking cessation aid Varenicline. | — |
Countries
Denmark, Sweden
Outcome results
None listed