At a glance
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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
In Brief
A Phase 2 clinical trial evaluating TA-NIC and Placebo for Smoking. Completed, enrolled 522 participants across 9 sites.
Detailed Summary
Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year. This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.
Study Details
Timeline
Interventions
TA-NIC vaccine will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.
Placebo will be administered to each subject as 7 single doses administered at Weeks 0, 2, 4, 6, 8, 12, and 16.