e-Cigarettes Versus NRT Gum for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01925781
• Other study ID #: 13-16684
• Status: Terminated
• Phase: Phase 4
• First received: August 16, 2013
• Last updated: December 10, 2015
• Start date: August 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Nicotine Addiction
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Drug:
• Nicotine polacrilex
2 mg and 4 mg gum will be used according to the FDA approved product labelling

Other:
• STAM 1100mAh CE4 eGo Clearomizer

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	Point Prevalence Abstinence	No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.	12 weeks	No