A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation
This is a multicenter, double-blind, randomized, placebocontrolled, 3-arm, Phase 2 study
evaluating the efficacy and safety of TA-NIC as an aid for smoking cessation in smokers
motivated to quit within 12 weeks. At the start of the study, each subject will set a Target
Quit Date, which must be within 12 weeks after first injection. Each subject will receive 7
injections (vaccinations) from Weeks 0 to 16. Subjects will be encouraged to follow a phased
reduction in cigarette consumption leading up to the Target Quit Date. All vaccinated
subjects will be offered a counseling session at each clinic visit and will be contacted by
telephone at Weeks 1, 3, 5, 7, 9, 14, 18, and 21 to provide up to 10 minutes of support and
counseling for their smoking cessation. Smoking cessation will be measured during a 4-week
assessment period from Week 22 to Week 26. Smoking cessation will be defined as complete
abstinence during this 4-week period. Subject follow-up will continue to Week 52.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
4-week assessment period quit rate at Week 26 measured by self-reported abstinence in the 4 weeks immediately prior to the 26 week visit and supported by CO breath test data
Week 26
No
Krefetz
Principal Investigator
CNS Research Institute, P.C
United States: Food and Drug Administration
TA-NIC/04
NCT00633321
May 2007
February 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Centennial Medical Group | Elkridge, Maryland 21075 |
Benchmark Research | Sacramento, California 95816 |
Benchmark Research | Metairie, Louisiana 70006 |
Columbia Medical Practice | Columbia, Maryland 21045 |
CNS Research Institute, P.C. | Clementon, New Jersey 08021 |
CRI Worldwide, LLC Kirkbride Center | Philadelphia, Pennsylvania 19139 |
Benchmark Research | Austin, Texas 78705 |
Benchmark Research - Fort Worth | Fort Worth, Texas 76135 |