Electronic Cigarettes in Daily Dependent Smokers
A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
April 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 5, 2015
May 1, 2015
1.1 years
April 7, 2014
May 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cue-induced nicotine craving
Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition
1 hour after condition
Secondary Outcomes (1)
Withdrawal-induced nicotine craving
3 hours after condition
Study Arms (2)
E-Cigarette with nicotine
ACTIVE COMPARATORElectronic cigarette with cartridge fluid containing nicotine
E-Cigarette without nicotine
PLACEBO COMPARATORElectronic cigarette with cartridge fluid containing no nicotine (placebo)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any serious medical or unstable psychiatric problems requiring treatment
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health, BACDRL Lab
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
Ng G, Attwells S, Selby P, Zawertailo L. Effectiveness of Non-Nicotinic E-Cigarettes to Reduce Cue- and Abstinence-Induced Cigarette Craving in Non-Treatment Seeking Daily Dependent Smokers. Psychopharmacology (Berl). 2021 Jun;238(6):1461-1472. doi: 10.1007/s00213-021-05772-4. Epub 2021 Jan 30.
PMID: 33515267DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurie Zawertailo, PhD
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Independent Scientist
Study Record Dates
First Submitted
April 7, 2014
First Posted
April 9, 2014
Study Start
March 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 5, 2015
Record last verified: 2015-05