e-Cigarettes Versus NRT Gum for Smoking Cessation

Creighton University

Status and phase: Terminated; Phase 4

Conditions: Nicotine Addiction; Smoking Cessation

Treatments: Other: STAM 1100mAh CE4 eGo Clearomizer; Drug: Nicotine polacrilex

Study type: Interventional

Funder types: Other

Identifiers

NCT01925781

13-16684

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

e-Cigarette

Experimental group

Description:

STAM 1100mAh CE4 eGo Clearomizer e-Cigarette

Treatment:

Other: STAM 1100mAh CE4 eGo Clearomizer

Nicotine polacrilex

Active Comparator group

Description:

Nicotine Replacement gum

Treatment:

Drug: Nicotine polacrilex