e-Cigarettes Versus NRT Gum for Smoking Cessation

Phase 4

Terminated

• Conditions: Nicotine Addiction; Smoking Cessation
• Interventions: Other: STAM 1100mAh CE4 eGo Clearomizer; Drug: Nicotine polacrilex

• Registration Number: NCT01925781
• Lead Sponsor: Creighton University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-12
• Results First Submitted: 2015-12-10
• Results First Submitted QC: 2015-12-10
• Last Update Submitted: 2015-12-10
• Results First Posted: 2016-01-14
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
e-Cigarette	STAM 1100mAh CE4 eGo Clearomizer	STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
Nicotine polacrilex	Nicotine polacrilex	Nicotine Replacement gum

Primary Outcome Measures

Name	Time	Method
Sustained Abstinence	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 Outcome Measures

Name	Time	Method
Point Prevalence Abstinence	12 weeks	No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.

Trial Locations

Locations (1)

Creighton University; 🇺🇸 Omaha, Nebraska, United States