EUCTR2007-003250-29-DKActive, not recruitingNot Applicable
A randomised, placebo-controlled, multi-centre study on the efficacy of Niccine, a vaccine for nicotine, in smoking relapse prevention, assessed in abstinent, adult smokers.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Independent Pharmaceutica AB
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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 investigational 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).
Investigators
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