Conditions: Smoking
Keywords: nicotine therapy fMRI/EEG replacement
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 23
Healthy volunteers: yes

Brief summary:
A single center, double blind, randomized, placebo controlled, two-treatments, two-period crossover study conducted in adult smokers.

Detailed description:
The main objective of this study is to use blood oxygen level-dependent (BOLD) functional Magnetic Resonance Imaging (fMRI) in abstinent smokers to directly evaluate the effect of the 4 milligrams (mg) nicotine lozenge on brain activation associated with visual attention. The experimental task featured 3 conditions: 1. a highly demanding cognitive/attention task, 2. a simple cognitive/attention task, and 3. simply look at a '+' symbol. During the experiment these conditions are each presented a number of times in an alternating manner while acquiring images.

Arms:
arm 1: Nicotine lozenge containing 4 mg of nicotine to be placed in mouth and suck to dissolution. arm 2: Placebo lozenge to be placed in mouth and suck to dissolution.

Interventions: intervention 1: Nicotine intervention 2: Placebo
Intervention descriptions: intervention 1: Nicotine lozenge containing 4 mg of nicotine intervention 2: Placebo lozenge

Protocol document: