Conditions: Smoking Cessation
Keywords: provoked craving
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 320
Healthy volunteers: yes

Brief summary:
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.

Detailed description:

Arms:
arm 1: mint nicotine mouth film, buccal administration arm 2: nicotine lozenge, buccal administration

Interventions: intervention 1: Nicotine
Intervention descriptions: intervention 1: Comparison of different dosage forms of nicotine

Protocol document: