e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
Overview
- Phase
- Phase 4
- Intervention
- STAM 1100mAh CE4 eGo Clearomizer
- Conditions
- Nicotine Addiction
- Sponsor
- Creighton University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Sustained Abstinence
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
e-Cigarette
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
Intervention: STAM 1100mAh CE4 eGo Clearomizer
Nicotine polacrilex
Nicotine Replacement gum
Intervention: Nicotine polacrilex
Outcomes
Primary Outcomes
Sustained Abstinence
Time Frame: 12 weeks
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 Outcomes
- Point Prevalence Abstinence(12 weeks)