NicVAX/Placebo as an Aid for Smoking Cessation

Phase 3CompletedNCT00836199

Nabi Biopharmaceuticals1,000 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,000

Conditions

Smoking Cessation Smoking Tobacco Cessation

Interventions

NicVAX vaccineBIOLOGICAL

NicVAX vaccine given 6 times over 6 months

Placebo vaccineBIOLOGICAL

Placebo vaccine given 6 times over 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (22)

NicVAX Investigator

Tucson, Arizona, United States

NicVAX Investigator

Los Angeles, California, United States

Outcomes

Primary Outcomes

Evaluate NicVAX as an aid to smoking cessation for long term abstinence.

Time frame: one year

Secondary Outcomes

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

Data from ClinicalTrials.gov

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