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e-Cigarettes Versus NRT Gum for Smoking Cessation

C

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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