- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108626
Electronic Cigarettes in Daily Dependent Smokers
May 4, 2015 updated by: Laurie Zawertailo, Centre for Addiction and Mental Health
A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2S1
- Centre for Addiction and Mental Health, BACDRL Lab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E-Cigarette with nicotine
Electronic cigarette with cartridge fluid containing nicotine
|
E-Cigarette with nicotine cartridge
|
Placebo Comparator: E-Cigarette without nicotine
Electronic cigarette with cartridge fluid containing no nicotine (placebo)
|
E-Cigarette with 0mg nicotine cartridge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cue-induced nicotine craving
Time Frame: 1 hour after condition
|
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
Time Frame: 3 hours after condition
|
Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition
|
3 hours after condition
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 7, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Estimate)
May 5, 2015
Last Update Submitted That Met QC Criteria
May 4, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Substance Withdrawal Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- 001/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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