Electronic Cigarettes in Daily Dependent Smokers

Nicotine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108626
• Other study ID #: 001/2014
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2014
• Last updated: May 4, 2015
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Substance Withdrawal Syndrome

Intervention

Drug:
• Nicotine
E-Cigarette with nicotine cartridge
• Placebo
E-Cigarette with 0mg nicotine cartridge

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health, BACDRL Lab	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cue-induced nicotine craving	Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition	1 hour after condition	No
Secondary	Withdrawal-induced nicotine craving	Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition	3 hours after condition	No

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital. It is fully affiliated with the University of Toronto, and is a PAHO/WHO Collaborating Centre