Clinical trial NCT02108626: Electronic Cigarettes in Daily Dependent Smokers
Official title: A Behavioral Assessment of Electronic Cigarettes in Reducing Cue- and Withdrawal-induced Craving in Daily Dependent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Substance Withdrawal Syndrome
Nicotine Dependence
Keywords: Electronic Cigarettes
Lozenge
Nicotine
Tobacco
Dependence
Withdrawal
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Cue-induced nicotine craving
timeFrame: 1 hour after condition
Secondary outcomes:
measure: Withdrawal-induced nicotine craving
timeFrame: 3 hours after condition
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health, BACDRL Lab
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie Zawertailo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.