NCT02108626

Electronic Cigarettes in Daily Dependent Smokers

A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to measure nicotine cue- and withdrawal-induced craving in current smokers under four distinct conditions: after smoking a conventional cigarette, an electronic cigarette (e-Cigarette) containing nicotine, an e-Cigarette without nicotine, and after taking a nicotine lozenge. Participants will be asked to attend four morning study visits after overnight smoking abstinence. Standardized questionnaires will be used to assess changes under each condition, allowing for the investigation of the efficacy of e-Cigarettes in reducing craving by replacing the behavioral component of smoking with minimal risk of adverse effects.

Detailed description

Many addiction models postulate stimuli to be linked with nicotine intake and reward after prolonged use. As such, smoking becomes more heavily based in habit, initiated by cues. Craving has been found to be a crucial component of continued smoking and relapse in response to various environmental and behavioral cues. Electronic Cigarettes (e-Cigarettes) are new smoking products emerging in consumer markets that often mimic conventional tobacco cigarettes. E-Cigarettes commonly include a cartridge, a heating element, a puff sensor, and a battery. When a user draws on the device, the heating element is activated and the cartridge fluid is vaporized. Users then inhale the aerosol containing droplets of the vaporized fluid. This study will empirically assess the efficacy of e-Cigarettes in alleviating craving by replacing the behavioral component of smoking. Using standardized questionnaires, intra-subject changes in cue- and withdrawal-induced craving after smoking an e-Cigarette without nicotine will be compared with that after either smoking a conventional cigarette, an e-Cigarette with nicotine, or taking a 4mg lozenge.

Conditions

• Substance Withdrawal Syndrome
• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Nicotine	E-Cigarette with nicotine cartridge
DRUG	Placebo	E-Cigarette with 0mg nicotine cartridge

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-04-09
• Last updated: 2015-05-05

Locations

1 site across 1 country: Canada