NCT01280968

Improving the Efficacy of Anti-Nicotine Immunotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Alexey Mukhin · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
BIOLOGICAL	NIC002 in Aluminum hydroxide (Alum)	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.
BIOLOGICAL	Placebo Vaccine - Aluminum hydroxide	Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-09-01
• Completion: 2013-04-01
• First posted: 2011-01-21
• Last updated: 2014-03-05
• Results posted: 2013-12-18

Locations

2 sites across 1 country: United States