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Electronic Cigarettes in Daily Dependent Smokers

Primary Purpose

Substance Withdrawal Syndrome, Nicotine Dependence

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Nicotine
Placebo
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Withdrawal Syndrome focused on measuring Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health, BACDRL Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

E-Cigarette with nicotine

E-Cigarette without nicotine

Arm Description

Electronic cigarette with cartridge fluid containing nicotine

Electronic cigarette with cartridge fluid containing no nicotine (placebo)

Outcomes

Primary Outcome Measures

Cue-induced nicotine craving
Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition

Secondary Outcome Measures

Withdrawal-induced nicotine craving
Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition

Full Information

First Posted
April 7, 2014
Last Updated
May 4, 2015
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02108626
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Withdrawal Syndrome, Nicotine Dependence
Keywords
Electronic Cigarettes, Lozenge, Nicotine, Tobacco, Dependence, Withdrawal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E-Cigarette with nicotine
Arm Type
Active Comparator
Arm Description
Electronic cigarette with cartridge fluid containing nicotine
Arm Title
E-Cigarette without nicotine
Arm Type
Placebo Comparator
Arm Description
Electronic cigarette with cartridge fluid containing no nicotine (placebo)
Intervention Type
Drug
Intervention Name(s)
Nicotine
Intervention Description
E-Cigarette with nicotine cartridge
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
E-Cigarette with 0mg nicotine cartridge
Primary Outcome Measure Information:
Title
Cue-induced nicotine craving
Description
Craving assessment after presentation of smoking- and neutral-cues 1 hour after condition
Time Frame
1 hour after condition
Secondary Outcome Measure Information:
Title
Withdrawal-induced nicotine craving
Description
Craving assessment after presentation of smoking- and neutral-cues 3 hours after condition
Time Frame
3 hours after condition

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health, BACDRL Lab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33515267
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.
Results Reference
derived
Links:
URL
http://www.camh.net/research
Description
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

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Electronic Cigarettes in Daily Dependent Smokers

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