Status:
COMPLETED
Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals
Lead Sponsor:
Nabi Biopharmaceuticals
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Smoking Cessation
Tobacco Use Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nic...
Detailed Description
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects...
Eligibility Criteria
Inclusion
- Current smoker
- Good general health, including mental health
- Alveolar carbon monoxide level greater than or equal to 10 ppm
Exclusion
- Prior exposure to NicVAX
- Known allergy to any of the components of NicVAX
- Use of any smoking cessation aide
- Pregnant or breastfeeding
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00218413
Start Date
October 1 2004
End Date
August 1 2006
Last Update
January 12 2017
Active Locations (1)
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1
University of Maastricht
Maastricht, Netherlands, 6229 HA