Electronic Cigarettes in Daily Dependent Smokers

Phase 4

Completed

• Conditions: Substance Withdrawal Syndrome; Nicotine Dependence
• Interventions: Drug: Nicotine; Drug: Placebo

• Registration Number: NCT02108626
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Current daily smoker
• Smoke minimum of 10 cigarettes per day
• Fagerstrom Test of Nicotine Dependence Score equal or greater than 3
• Never used an e-Cigarette prior to the study
• No intention to quit smoking within the next 3 months
• Able to provide written informed consent
• Able and willing to attend scheduled appointments

Exclusion Criteria

• Any serious medical or unstable psychiatric problems requiring treatment
• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
E-Cigarette with nicotine	Nicotine	Electronic cigarette with cartridge fluid containing nicotine
E-Cigarette without nicotine	Placebo	Electronic cigarette with cartridge fluid containing no nicotine (placebo)

Primary Outcome Measures

Name	Time	Method
Cue-induced nicotine craving	1 hour after condition	Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition

Secondary Outcome Measures

Name	Time	Method
Withdrawal-induced nicotine craving	3 hours after condition	Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition

Trial Locations

Locations (1)

Centre for Addiction and Mental Health, BACDRL Lab; 🇨🇦 Toronto, Ontario, Canada