Electronic Cigarettes in Daily Dependent Smokers

Study Overview
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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.

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.

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

Conditions
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Substance Withdrawal Syndrome, Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine
* Drug: Placebo


Participation Criteria
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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 Exclusion Criteria: Any serious medical or unstable psychiatric problems requiring treatment Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: E-Cigarette with nicotine<br>Electronic cigarette with cartridge fluid containing nicotine | Drug: Nicotine<br>* E-Cigarette with nicotine cartridge<br>|
| Placebo Comparator: E-Cigarette without nicotine<br>Electronic cigarette with cartridge fluid containing no nicotine (placebo) | Drug: Placebo<br>* E-Cigarette with 0mg nicotine cartridge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cue-induced nicotine craving | Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition | 1 hour after condition | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal-induced nicotine craving | Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition | 3 hours after condition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal