Back to resultse-Cigarettes Versus NRT Gum for Smoking Cessation
Primary Purpose
Nicotine Addiction, Smoking Cessation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nicotine polacrilex
STAM 1100mAh CE4 eGo Clearomizer
Sponsored by
About this trial
This is an interventional supportive care trial for Nicotine Addiction focused on measuring Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy
Eligibility Criteria
Inclusion Criteria:
- Smokes at least five cigarettes per day
- No current or previous regular use of e-cigarettes
- Ready to quit smoking
Exclusion Criteria:
- Use of smokeless or pipe tobacco
- Smoke more than 40 cigarettes per day
- Pregnant or breastfeeding
- Unable to chew gum due to dental or jaw problems
- Myocardial infarction (heart attack) within the previous 12 months
- Hypersensitivity to propylene glycol or nicotine gum
Sites / Locations
- Creighton University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
e-Cigarette
Nicotine polacrilex
Arm Description
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
Nicotine Replacement gum
Outcomes
Primary Outcome Measures
Sustained Abstinence
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
Secondary Outcome Measures
Point Prevalence Abstinence
No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.
Full Information
NCT ID
NCT01925781
First Posted
August 16, 2013
Last Updated
December 10, 2015
Sponsor
Creighton University
1. Study Identification
Unique Protocol Identification Number
NCT01925781
Brief Title
e-Cigarettes Versus NRT Gum for Smoking Cessation
Official Title
e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
IND required
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Creighton University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Addiction, Smoking Cessation
Keywords
Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
e-Cigarette
Arm Type
Experimental
Arm Description
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
Arm Title
Nicotine polacrilex
Arm Type
Active Comparator
Arm Description
Nicotine Replacement gum
Intervention Type
Drug
Intervention Name(s)
Nicotine polacrilex
Other Intervention Name(s)
Nicotine Gum
Intervention Description
2 mg and 4 mg gum will be used according to the FDA approved product labelling
Intervention Type
Other
Intervention Name(s)
STAM 1100mAh CE4 eGo Clearomizer
Other Intervention Name(s)
e-Cigarette, electronic nicotine delivery device
Primary Outcome Measure Information:
Title
Sustained Abstinence
Description
No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Point Prevalence Abstinence
Description
No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Smokes at least five cigarettes per day
No current or previous regular use of e-cigarettes
Ready to quit smoking
Exclusion Criteria:
Use of smokeless or pipe tobacco
Smoke more than 40 cigarettes per day
Pregnant or breastfeeding
Unable to chew gum due to dental or jaw problems
Myocardial infarction (heart attack) within the previous 12 months
Hypersensitivity to propylene glycol or nicotine gum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy J Arouni, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68178
Country
United States
12. IPD Sharing Statement
Learn more about this trial
e-Cigarettes Versus NRT Gum for Smoking Cessation
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