Nicotine Vaccination and Nicotinic Receptor Occupancy

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Collaborators: Nabi Biopharmaceuticals; National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine; Vaccines

Criteria

Inclusion Criteria:

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

• Good general health

Exclusion Criteria:

• 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.