Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Nabi Biopharmaceuticals National Institute on Drug Abuse (NIDA) |
---|---|
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218413 |
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.
Condition | Intervention | Phase |
---|---|---|
Smoking Cessation Tobacco Use Cessation |
Biological: NicVAX |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study to Assess Safety and Immunogenicity of Five Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) Administered to Smokers |
Enrollment: | 51 |
Study Start Date: | October 2004 |
Study Completion Date: | August 2006 |
Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 & 182
|
2: Experimental |
Biological: NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 & 182
|
3: Experimental |
Biological: NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 & 182
|
4: Experimental |
Biological: NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 & 182
|
5: Experimental |
Biological: NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 & 182
|
Tobacco use is the single leading preventable cause of death in the United States. Nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. Immunotherapy may be useful in preventing and treating nicotine dependent individuals. NicVAX is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. The purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of NicVAX in treating nicotine dependent individuals.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
University of Maastricht | |
Maastricht, Netherlands, 6229 HA |
Principal Investigator: | Gary Horwith | Nabi Biopharmaceuticals |
Principal Investigator: | Arjen De Vos, MD, PhD | Nabi Biopharmaceuticals |
Responsible Party: | Nabi Biopharmaceuticals ( Arjen DeVos/ Senior Director, Medical Affairs and Clinical Research ) |
Study ID Numbers: | NIDA-17894-2, Nabi-4505, R01-17894-2, DPMC |
Study First Received: | September 16, 2005 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00218413 |
Health Authority: | Netherlands: Independent Ethics Committee; United States: Federal Government |
Vaccine Immunogenicity Randomized Controlled Trial Addiction |
Nicotine polacrilex Smoking Behavior, Addictive Nicotine |