Status:
COMPLETED
Efficacy of NicVAX in Smokers Who Want to Quit Smoking
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
Nabi Biopharmaceuticals
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether vaccination with NicVAX will result in a higher continuous abstinence rate than vaccination with placebo in smokers who want to quit smoking. In addit...
Detailed Description
Cigarette smoking is responsible for over 400,000 (1 out of every 5) deaths in the United States each year. Most smokers are aware of the health consequences and want to quit, but have difficulty doin...
Eligibility Criteria
Inclusion
- Smokes at least 15 cigarettes per day
- Wants to quit smoking
- Good general health
- Negative pregnancy test prior to study entry
- Carbon monoxide level greater than 10 ppm
Exclusion
- Prior exposure to NicVAX or any other nicotine vaccine
- Known allergic reaction to alum or any of the components of the vaccine
- Use of steroids, immunosuppressive agents or other medication that might interfere with an immune response
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00318383
Start Date
May 1 2006
End Date
December 1 2007
Last Update
January 12 2017
Active Locations (9)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
University of California
San Francisco, California, United States, 94143
3
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
4
Department of Public & Community Health
College Park, Maryland, United States, 20742