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Completed

NCT Number: NCT02108626

Electronic Cigarettes in Daily Dependent Smokers

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Addiction and Mental Health, BACDRL Lab

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicotine

Drug

E-Cigarette with nicotine cartridge

Placebo

Drug

E-Cigarette with 0mg nicotine cartridge

Primary outcomes

  1. Cue-induced nicotine craving

    Time frame: 1 hour after condition

    Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition

Secondary outcomes

  1. Withdrawal-induced nicotine craving

    Time frame: 3 hours after condition

    Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2014
Registry last updated
May 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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