Status:
COMPLETED
Nicotine Vaccination and Nicotinic Receptor Occupancy
Lead Sponsor:
Yale University
Collaborating Sponsors:
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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. ...
Detailed Description
The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine...
Eligibility Criteria
Inclusion
- Current smoker who smokes at least 10-25 cigarettes a day
- Good general health
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00996034
Start Date
September 1 2009
End Date
February 1 2011
Last Update
December 24 2015
Active Locations (1)
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1
Veterans Association Connecticut Hospital System
West Haven, Connecticut, United States, 06516