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e-Cigarettes Versus NRT Gum for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT01925781
Recruitment Status : Terminated (IND required)
First Posted : August 20, 2013
Results First Posted : January 14, 2016
Last Update Posted : January 14, 2016
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nicotine Addiction Smoking Cessation Drug: Nicotine polacrilex Other: STAM 1100mAh CE4 eGo Clearomizer Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: e-Cigarettes Versus Nicotine Replacement Therapy for Smoking Cessation
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
Experimental: e-Cigarette
STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
 Other: STAM 1100mAh CE4 eGo Clearomizer
Other Names:
  • e-Cigarette
  • electronic nicotine delivery device
Active Comparator: Nicotine polacrilex
Nicotine Replacement gum
 Drug: Nicotine polacrilex
2 mg and 4 mg gum will be used according to the FDA approved product labelling
Other Name: Nicotine Gum


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Point Prevalence Abstinence [ Time Frame: 12 weeks ]
    No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925781


Locations
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United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Creighton University
Investigators
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Principal Investigator: Amy J Arouni, MD Creighton University
More Information
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Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01925781    
Other Study ID Numbers: 13-16684
First Posted: August 20, 2013    Key Record Dates
Results First Posted: January 14, 2016
Last Update Posted: January 14, 2016
Last Verified: December 2015
Keywords provided by Creighton University:
Smoking Cessation
Nicotine Addiction
e-Cigarette
 electronic nicotine delivery device
electronic cigarette
nicotine replacement therapy
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action