Nicotine Vaccination and Nicotinic Receptor Occupancy

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Yale University

Status and phase

Completed
Phase 2

Conditions

Nicotine Dependence

Treatments

Drug: Nicotine bitartrate
Radiation: [123I]5-IA-85380
Biological: NicVAX

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT00996034
R21DA024388 (U.S. NIH Grant/Contract)
0804003655

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

Healthy Smoker
Experimental group
Description:
There is only one arm to the study. All subjects will receive NicVax, [123I]5-I-A-85380,and Nicotine bitartrate.
Treatment:
Biological: NicVAX
Radiation: [123I]5-IA-85380
Drug: Nicotine bitartrate

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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