At a glance
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Improving the Efficacy of Anti-Nicotine Immunotherapy
In Brief
A Phase 2 clinical trial evaluating NIC002 in Aluminum hydroxide (Alum) and Placebo Vaccine - Aluminum hydroxide for Nicotine Dependence. Completed, enrolled 52 participants across 2 sites.
Detailed Summary
The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.
Study Details
Timeline
Interventions
Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.
Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.