Nicotine Vaccination and Nicotinic Receptor Occupancy

Completed · Phase 2

Conditions studied: Nicotine Dependence

In brief

This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker. In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.

Key facts

Study ID

NCT00996034

Run by

Yale University

People needed

14

Starts

2009-09-01

Expected to finish

2011-02-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Current smoker who smokes at least 10-25 cigarettes a day
• Good general health

You may not qualify if…

• Subjects with a pacemaker or other ferromagnetic material in body.
• Prior exposure to NicVAX or any other nicotine vaccine.
• Use of systemic steroids or other immunosuppressive agent
• History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness
• Cancer or cancer treatment in last 5 years
• HIV infection
• Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin), within 30 days prior to administration of NicVAX and for the duration of the study.
• Inability to fulfill all visits and examination procedures for approximately 20 weeks.

Where it is running

• Veterans Association Connecticut Hospital System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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