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Electronic Cigarettes in Daily Dependent Smokers

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ClinicalTrials.gov Identifier: NCT02108626
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):
Laurie Zawertailo, 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.

Condition or disease Intervention/treatment Phase
Substance Withdrawal Syndrome Nicotine Dependence Drug: Nicotine Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: E-Cigarette with nicotine
Electronic cigarette with cartridge fluid containing nicotine
Drug: Nicotine
E-Cigarette with nicotine cartridge

Placebo Comparator: E-Cigarette without nicotine
Electronic cigarette with cartridge fluid containing no nicotine (placebo)
Drug: Placebo
E-Cigarette with 0mg nicotine cartridge




Primary Outcome Measures :
  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 Outcome Measures :
  1. Withdrawal-induced nicotine craving [ Time Frame: 3 hours after condition ]
    Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108626


Locations
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Canada, Ontario
Centre for Addiction and Mental Health, BACDRL Lab
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Laurie Zawertailo, PhD Centre for Addiction and Mental Health

Additional Information:
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Responsible Party: Laurie Zawertailo, Independent Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02108626     History of Changes
Other Study ID Numbers: 001/2014
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015
Keywords provided by Laurie Zawertailo, Centre for Addiction and Mental Health:
Electronic Cigarettes
Lozenge
Nicotine
Tobacco
Dependence
Withdrawal
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action