NCT01318668

Brief Summary

In this study the effects of a nicotine challenge on brain activity, behavior and mood will be evaluated in two groups of healthy volunteers who have a smoking habbit: The first group will undergo a series of treatments with NicVax, aimed at producing nicotine antibodies in the body and preventing nicotine to enter the brain. The second group will receive a placebo treatment. This pre-treatment (vaccination) will take place over a 18-week period. All participants will then undergo two days of testing. On each day the subjects will perform a number of psychomotor and memory tests after a challenge with nicotine (gum) or placebo(gum). Also brain activity will be studied in an fMRI scanner. We expect to see an effect on brain activation and performance only in the placebo-vaccinated group. The Nicvax vaccinated group should show activation and performance comparable to that after challenge with placebo(gum) as in this group nicotine should not cross the blood brain barrier and enter the brain

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 17, 2011

Last Update Submit

March 1, 2013

Conditions

Nicotine DependencySmoking

Keywords

fmri smoking vaccination mood

Outcome Measures

Primary Outcomes (2)

  • FMRI

    Regional blood oxygenated level dependent (BOLD) response (method: BOLD functional MRI) during resting state and during task performance, in regions of interest, before and after nicotine administration.

    at 18 and 20 weeks post vaccination

  • Reaction time

    Task performance; the number of correct response and the reaction time in a battery of psycho-motor tests.

    at 18 and 20 weeks post vaccination

Secondary Outcomes (1)

  • Mood

    18 and 20 weeks post vaccination

Study Arms (1)

Nicotine vaccination

EXPERIMENTAL

18 week treatment with Nicvax

Biological: vaccination with Nicvax

Interventions

vaccination with NicvaxBIOLOGICAL

5 vaccinations of NicVax 400ug (1 ml) over a 18 week period or matching placebo.

Also known as: NicVAX is a P. earoginosa r-Exoprotein conjugate vaccine.
Nicotine vaccination

Eligibility Criteria

Age25 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Health male right handed volunteers between 25-40 years of age.
  • Smoking at least 10 cigarettes per day

You may not qualify if:

  • Contra indications for MRI scanner
  • History of neurological or psychiatric disease
  • known immunodeficiency
  • current use of psychoactive medication
  • excessive alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6226cc, Netherlands

Location

Related Publications (1)

  • Havermans A, Vuurman EF, van den Hurk J, Hoogsteder P, van Schayck OC. Treatment with a nicotine vaccine does not lead to changes in brain activity during smoking cue exposure or a working memory task. Addiction. 2014 Aug;109(8):1260-7. doi: 10.1111/add.12577. Epub 2014 Jun 3.

    PMID: 24894701DERIVED

MeSH Terms

Conditions

Smoking

Interventions

VaccinationNicVAX

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Eric Vuurman

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

NL(1)