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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019381-90-NL

Enrollment

Registered

2010-03-16

Start date

2010-07-05

Completion date

Unknown

Last updated

2023-12-12

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

Conditions

Nicotine addiction/smoking MedDRA version: 12.1 Level: LLT Classification code 10056478 Term: Nicotine addiction MedDRA version: 12.1 Level: LLT Classification code 10056484 Term: Nicotine craving MedDRA version: 12.1 Level: LLT Classification code 10057852 Term: Nicotine dependence

Interventions

Trade Name: Nicotinell Mint 2 mg, kauwgom Product Name: Nicotinell Mint 2 mg, kauwgom Product Code: UK/H/0134/001 Pharmaceutical Form: Chewable tablet INN or Proposed INN: nicotine CAS Number: UK/H/01

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male volunteers; smoking at least 10 cigarettes a day over the past year Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: contraindications for fMRI (metal parts etc, brain trauma, psychoactive medication contraindications for the nicotine challenge (recent myocardial disease ) contraindications for vaccination; allergies, immunodifficiencies, recent malignancy or chemotherapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To show that NicVAX attenuates nicotine induced CNS effecst on brain activation and cognitive performance relative to placebo;Secondary Objective: To evaluate how these changes in CNS stimulation alter subjective measures and the addictive properties of nicotine;Primary end point(s): 1) changes in BOLD fMRI after a nicotine challenge vs placebo in NicVAX vs placebo vaccinated groups 2) changes in cognitive performance after nicotine challenge vs placebo 3) changes in subjective measures (ie craving, mood)	—

Measure

Time frame

Main Objective: To show that NicVAX attenuates nicotine induced CNS effecst on brain activation and cognitive performance relative to placebo;Secondary Objective: To evaluate how these changes in CNS stimulation alter subjective measures and the addictive properties of nicotine;Primary end point(s): 1) changes in BOLD fMRI after a nicotine challenge vs placebo in NicVAX vs placebo vaccinated groups 2) changes in cognitive performance after nicotine challenge vs placebo 3) changes in subjective measures (ie craving, mood)

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026