Phase 2
N=14
Nicotine Vaccination and Nicotinic Receptor Occupancy
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00996034 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 — 54.9; 49.1 percentage of average nicotine binding — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NicVAX (Biological); [123I]5-IA-85380 (Radiation); Nicotine bitartrate (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 |
54.9; 49.1 | <0.05 sig |
Summary
This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker.
In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.
Eligibility Criteria
Inclusion Criteria
- Current smoker who smokes at least 10-25 cigarettes a day
- Good general health
Exclusion Criteria
- Subjects with a pacemaker or other ferromagnetic material in body.
- Prior exposure to NicVAX or any other nicotine vaccine.
- Use of systemic steroids or other immunosuppressive agent
- History of significant neurological, cardiovascular, hepatic, endocrine, renal, liver, psychiatric or thyroid illness
- Cancer or cancer treatment in last 5 years
- HIV infection
- Use of varenicline (Chantix), bupropion (Wellbutrin, Zyban), mecamylamine (Inversin), within 30 days prior to administration of NicVAX and for the duration of the study.
- Inability to fulfill all visits and examination procedures for approximately 20 weeks.
Data sourced from ClinicalTrials.gov (NCT00996034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.