This study aims to provide initial insights into the impact of orally delivered nicotine on attentional performance in adult occasional users of nicotine pouches. Nicotine will be administered via a dissolvable tablet for approximately 10 minutes. The main objective of this exploratory study is to characterize the effect of nicotine on attentional performance, using metrics derived from Continuous Performance Test (CPT). Additionally, a second CPT assessment will be conducted two hours after the first administration to explore the potential sustained effects of nicotine on attention as an exploratory objective.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
NICOTINE TABLET (nicotine content 0mg; Mint flavor)
NICOTINE TABLET (nicotine content 0.5mg; Mint flavor)
NICOTINE TABLET (nicotine content 1.0mg; Mint flavor)
NICOTINE TABLET (nicotine content 1.5mg; Mint flavor)
NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
CTC Clinical Trial Consultants AB
Uppsala, Sweden
Change in attentional performance after 15 minutes
To evaluate the effect of nicotine on attentional performance following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine. Attentional performance will be assessed 15 minutes after the start of product use using the Conners Continuous Performance Test (CPT).
Time frame: 15 minutes after the start of product use
Change in attentional performance after 2 hours
To evaluate the effect of nicotine on attentional performance following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine. Attentional performance will be assessed 2 hours after the start of product use using the Conners Continuous Performance Test (CPT).
Time frame: 2 hours after the start of product use
Change in self-reported craving for nicotine pouch use
Participants will rate their craving on a 100 mm unipolar scale (0 = no craving, 100 = strong craving) in response to the question: "How strong is your craving for using a nicotine pouch?" following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine.
Time frame: 10 minutes after the start of product use
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