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NicVAX/Placebo as an Aid for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00836199
First received: February 3, 2009
Last updated: May 8, 2012
Last verified: May 2012
February 3, 2009
May 8, 2012
October 2009
July 2011   (Final data collection date for primary outcome measure)
Evaluate NicVAX as an aid to smoking cessation for long term abstinence. [ Time Frame: one year ]
Evaluate NicVAX as an aid to smoking cessation [ Time Frame: one year ]
Complete list of historical versions of study NCT00836199 on ClinicalTrials.gov Archive Site
  • Evaluate abstinence rates at multiple intervals [ Time Frame: multiple time points ]
  • Evaluate safety and immunogenicity [ Time Frame: mulitple time points ]
  • Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. [ Time Frame: multiple time points ]
Same as current
Not Provided
Not Provided
 
NicVAX/Placebo as an Aid for Smoking Cessation
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy, Immunogenicity and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) as an Aid to Smoking Cessation
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Smoking Cessation
  • Smoking
  • Tobacco Cessation
  • Biological: NicVAX vaccine
    NicVAX vaccine given 6 times over 6 months
  • Biological: Placebo vaccine
    Placebo vaccine given 6 times over 6 months
  • Placebo Comparator: Placebo vaccine
    Intervention: Biological: Placebo vaccine
  • Experimental: NicVAX vaccine
    Intervention: Biological: NicVAX vaccine
Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00836199
Nabi-4514
NIH grant # 1 RC2 DA028837-01
Yes
Not Provided
Not Provided
Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Study Director: Medical Monitor Nabi Biopharmaceuticals
Nabi Biopharmaceuticals
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP