Safety and Effectiveness of NicVAX in Treating Nicotine Dependent Individuals
NCT ID: NCT00218413
Last Updated: 2017-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2004-10-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
2
NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
3
NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182
4
NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
5
NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
Interventions
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NicVAX
100 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
NicVAX
200 μg, Formulation A, on Days 0, 21, 42, 91 \& 182
NicVAX
200 μg, Formulation B, on Days 0, 21, 42m 91 \& 182
NicVAX
300 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
NicVAX
400 μg, Formulation B, on Days 0, 21, 42, 91 \& 182
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Good general health, including mental health
* Alveolar carbon monoxide level greater than or equal to 10 ppm
Exclusion Criteria
* Known allergy to any of the components of NicVAX
* Use of any smoking cessation aide
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Nabi Biopharmaceuticals
INDUSTRY
Responsible Party
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Nabi Biopharmaceuticals
Principal Investigators
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Gary Horwith
Role: PRINCIPAL_INVESTIGATOR
Nabi Biopharmaceuticals
Arjen De Vos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Nabi Biopharmaceuticals
Locations
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University of Maastricht
Maastricht, , Netherlands
Countries
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Other Identifiers
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Nabi-4505
Identifier Type: -
Identifier Source: secondary_id
R01-17894-2
Identifier Type: -
Identifier Source: secondary_id
DPMC
Identifier Type: -
Identifier Source: secondary_id
NIDA-17894-2
Identifier Type: -
Identifier Source: org_study_id
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