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Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals

NCT00218413 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-01-12

No results posted yet for this study

Summary

Nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. The purpose of this study is to determine the effectiveness of various doses of NicVAX in treating nicotine dependent individuals.

Conditions

  • Smoking Cessation
  • Tobacco Use Cessation

Interventions

BIOLOGICAL

NicVAX

100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182

BIOLOGICAL

NicVAX

200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182

BIOLOGICAL

NicVAX

200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182

BIOLOGICAL

NicVAX

300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182

BIOLOGICAL

NicVAX

400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Nabi Biopharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gary Horwith · Nabi Biopharmaceuticals

  • Arjen De Vos, MD, PhD · Nabi Biopharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00218413 on ClinicalTrials.gov