Phase 2 Completed N=14 Health Services Research

Nicotine Vaccination and Nicotinic Receptor Occupancy

Source: ClinicalTrials.gov NCT00996034 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcomePrimary: Mean of the Average Nicotine Binding % at Scan 1 and Scan 2 — 54.9; 49.1 percentage of average nicotine binding — p=<0.05

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.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.