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NicVAX/Placebo as an Aid for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00836199
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : May 9, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Nabi Biopharmaceuticals

Brief Summary:
The purpose of this study is to evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Condition or disease Intervention/treatment Phase
Smoking Cessation Smoking Tobacco Cessation Biological: NicVAX vaccine Biological: Placebo vaccine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo vaccine Biological: Placebo vaccine
Placebo vaccine given 6 times over 6 months
Experimental: NicVAX vaccine Biological: NicVAX vaccine
NicVAX vaccine given 6 times over 6 months



Primary Outcome Measures :
  1. Evaluate NicVAX as an aid to smoking cessation for long term abstinence. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Evaluate abstinence rates at multiple intervals [ Time Frame: multiple time points ]
  2. Evaluate safety and immunogenicity [ Time Frame: mulitple time points ]
  3. Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence. [ Time Frame: multiple time points ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836199


  Show 22 Study Locations
Sponsors and Collaborators
Nabi Biopharmaceuticals
National Institute on Drug Abuse (NIDA)
Investigators
Study Director: Medical Monitor Nabi Biopharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00836199     History of Changes
Other Study ID Numbers: Nabi-4514
NIH grant # 1 RC2 DA028837-01
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: May 9, 2012
Last Verified: May 2012

Keywords provided by Nabi Biopharmaceuticals:
smoking cessation
NicVAX
smoking vaccine
smoking abstinence
smoking
tobacco cessation

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs