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A Second Study of NicVAX/Placebo as an Aid for Smoking Cessation

N

Nabi Biopharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Smoking Cessation

Treatments

Biological: NicVAX Vaccine
Biological: Placebo Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01102114
Nabi-4515

Details and patient eligibility

About

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

Enrollment

1,000 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 the 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

1,000 participants in 2 patient groups, including a placebo group

Placebo Vaccine
Placebo Comparator group
Treatment:
Biological: Placebo Vaccine
NicVAX Vaccine
Experimental group
Treatment:
Biological: NicVAX Vaccine

Trial contacts and locations

25

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Data sourced from clinicaltrials.gov

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