drugset / Trial / NCT01280968
Improving the Efficacy of Anti-Nicotine Immunotherapy
Phase 2
Completed
52 enrolled
Alexey Mukhin
Novartis Pharmaceuticals · collabWake Forest University Health Sciences · collab
RandomizedParallel-groupSingle-blindBasic science
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.
Timeline
- Start
- 2010-12
- Primary completion
- 2012-09
- Completion
- 2013-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NIC002 | Vaccine | 0.1 mg | Subcutaneous |