Electronic Cigarettes in Daily Dependent Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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

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Substance Withdrawal Syndrome Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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E-Cigarette with nicotine

Electronic cigarette with cartridge fluid containing nicotine

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

E-Cigarette with nicotine cartridge

E-Cigarette without nicotine

Electronic cigarette with cartridge fluid containing no nicotine (placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

E-Cigarette with 0mg nicotine cartridge

Interventions

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Nicotine

E-Cigarette with nicotine cartridge

Intervention Type DRUG

Placebo

E-Cigarette with 0mg nicotine cartridge

Intervention Type DRUG

Eligibility Criteria

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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