Status:
COMPLETED
NicVAX/Placebo as an Aid for Smoking Cessation
Lead Sponsor:
Nabi Biopharmaceuticals
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Smoking
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Eligibility Criteria
Inclusion
- Current smoker who smokes at least 10 cigarettes a day during the past year and wants to quit smoking.
- Smokers who are in good general health.
Exclusion
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids.
- Cancer or cancer treatment in last 5 years.
- HIV infection.
- History of drug or alcohol abuse or dependence within 12 months.
- Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
- Inability to fulfill all visits for approximately 52 weeks.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00836199
Start Date
October 1 2009
End Date
July 1 2011
Last Update
May 9 2012
Active Locations (22)
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1
NicVAX Investigator
Tucson, Arizona, United States
2
NicVAX Investigator
Los Angeles, California, United States
3
NicVAX Investigator
Newport Beach, California, United States
4
NicVAX Investigator
San Diego, California, United States