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An fMRI-study on the effects of NicVAX® and placebo on Central Nervous System activation and behaviour following a nicotine challenge.

An fMRI-study on the effects of NicVAX® and placebo on Central Nervous System activation and behaviour following a nicotine challenge. - fMRI study NicVAX

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36778
Enrollment
48
Registered
2010-03-24
Start date
2011-03-31
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

De verslavende eigenschappen van nicotine en de mogelijke behandeling dmv vaccinatie worden onderzocht, rookgedrag levert een verhoogd risico op een scala van medische aandoeningen, preventie of vroege behandeling is daardoor gewenst. nicotine addiction smoking

Interventions

The group will be randomised in two subgroups, one will recieve 5 injections with NicVAX, 4 weeks inbetween in the alternating deltoid muscle, the other group will recieve placebo vaccinations. On

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male,18-45 years of age, smoking at least 10 cigarettes/day the last year, right handed in general good health

Exclusion criteria

Exclusion criteria: Vaccination exclusion: allergic reactions, known immunodeficiencies, current or recent malignancy or chemotherapy fMRI exclusion: claustrofobia, metalic implants etc, use of psychofarmaca nicotine challenge: buccumucosal leasions

Design outcomes

Primary

MeasureTime frame
correlation between nicotine specific antibody and 1) the BOLD response during resting state, during the smoking-cue reactivity paradigm and during task performance; in regions of interest associated with the specific tasks; 2) the number of correct response and the reaction time;

Secondary

MeasureTime frame
Correlation between nicotine specific antibody and subjective signs of nicotine addiction, measured with several questionnaires

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)