Clinical trial NCT00836199: NicVAX/Placebo as an Aid for Smoking Cessation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Smoking
Tobacco Cessation
Keywords: smoking cessation
NicVAX
smoking vaccine
smoking abstinence
smoking
tobacco cessation
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-02-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Evaluate NicVAX as an aid to smoking cessation for long term abstinence.
timeFrame: one year
Secondary outcomes:
measure: Evaluate abstinence rates at multiple intervals
timeFrame: multiple time points
measure: Evaluate safety and immunogenicity
timeFrame: mulitple time points
measure: Evaluate withdrawal symptoms, smoking satisfaction, cigarette consumption and nicotine dependence.
timeFrame: multiple time points
Other outcomes:
Locations:
city: Tucson
country: United States
facility: NicVAX Investigator
state: Arizona
city: Los Angeles
country: United States
facility: NicVAX Investigator
state: California
city: Newport Beach
country: United States
facility: NicVAX Investigator
state: California
city: San Diego
country: United States
facility: NicVAX Investigator
state: California
city: Denver
country: United States
facility: NicVAX Investigator
state: Colorado
city: Farmington
country: United States
facility: NicVAX Investigator
state: Connecticut
city: Miami
country: United States
facility: NicVAX Investigator
state: Florida
city: St. Petersburg
country: United States
facility: NicVAX Investigator
state: Florida
city: Boise
country: United States
facility: NicVAX Investigator
state: Idaho
city: Lexington
country: United States
facility: NicVAX Investigator
state: Kentucky
city: Baltimore
country: United States
facility: NicVAX Investigator
state: Maryland
city: College Park
country: United States
facility: NicVAX Investigator
state: Maryland
city: Boston
country: United States
facility: NicVAX Investigator
state: Massachusetts
city: Minneapolis
country: United States
facility: NicVAX Investigator
state: Minnesota
city: Omaha
country: United States
facility: NicVAX Investigator
state: Nebraska
city: Rochester
country: United States
facility: NicVAX Investigator
state: New York
city: Raleigh
country: United States
facility: NicVAX Investigator
state: North Carolina
city: Portland
country: United States
facility: NicVAX Investigator
state: Oregon
city: Draper
country: United States
facility: NicVAX Investigator
state: Utah
city: Norfolk
country: United States
facility: NicVAX Investigator
state: Virginia
city: Seattle
country: United States
facility: NicVAX Investigator
state: Washington
city: Madison
country: United States
facility: NicVAX Investigator
state: Wisconsin
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Fahim RE, Kessler PD, Fuller SA, Kalnik MW. Nicotine vaccines. CNS Neurol Disord Drug Targets. 2011 Dec;10(8):905-15. doi: 10.2174/187152711799219343.