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Nicotine Vaccination and Nicotinic Receptor Occupancy

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nicotine Dependence

Intervention: NicVAX (Biological); [123I]5-IA-85380 (Radiation); Nicotine bitartrate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Irina Esterlis, Ph.D., Principal Investigator, Affiliation: Yale University

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.

Clinical Details

Official title: 123I-5-IA SPECT Imaging of Nicotinic Receptors and Effects of Nicotine Vaccine

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: Brain nicotine acetylcholine receptor occupancy before and after vaccine administration

Secondary outcome: Correlation of brain nicotine acetylcholine receptor occupancy with behavioral characteristics of smoking

Detailed description: The purpose of the present study is to examine the occupancy of brain β2-containing nicotinic acetylcholine receptors (β2-nAChR) by nicotine both at baseline and following administration of a nicotine vaccine. The number of brain β2-nAChR and the amount of nicotine occupancy both before and after vaccination will be measured using the nicotinic agonist [123I]5-IA-85380 ([123I]5-IA) and single photon emission computed tomography (SPECT). [123I]5-IA will be administered using the bolus plus constant infusion paradigm to smokers abstinent for 4-9 days (time period necessary for nicotine and pharmacological active metabolites to clear from brain). Three baseline SPECT images will be obtained after equilibrium has been reached (~6 hours into the [123I]5-IA infusion). Then, IV nicotine will be administered (0. 5-1. 5 mg/70 kg will be infused over 10 minutes). Following a series of 4 nicotine vaccine shots, the same procedure will be repeated for a second [123I]5-IA scan day. We hypothesize that occupancy of β2-nAChR will be significantly lower, and take longer to plateau, following nicotine vaccine administration.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Veterans Association Connecticut Hospital System, West Haven, Connecticut 06516, United States
Additional Information

Starting date: September 2009
Last updated: July 17, 2012

Page last updated: August 23, 2015

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