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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108626
Enrollment
43
Registered
2014-04-09
Start date
2014-03-31
Completion date
2015-04-30
Last updated
2015-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Substance Withdrawal Syndrome

Keywords

Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal

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.

Interventions

DRUGNicotine

E-Cigarette with nicotine cartridge

DRUGPlacebo

E-Cigarette with 0mg nicotine cartridge

Sponsors

Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cue-induced nicotine craving1 hour after conditionCraving assessment after presentation of smoking- and neutral-cues 1 hour after condition

Secondary

MeasureTime frameDescription
Withdrawal-induced nicotine craving3 hours after conditionCraving assessment after presentation of smoking- and neutral-cues 3 hours after condition

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026