e-Cigarettes Versus NRT Gum for Smoking Cessation

NCT01925781 | Terminated Phase 4 Results

• 1 other identifier: 13-16684
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Addiction; Smoking Cessation

Keywords

Smoking Cessation; Nicotine Addiction; e-Cigarette; electronic nicotine delivery device; electronic cigarette; nicotine replacement therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Point Prevalence Abstinence

  12 weeks

Study Arms (2)

e-Cigarette

EXPERIMENTAL

STAM 1100mAh CE4 eGo Clearomizer e-Cigarette

Other: STAM 1100mAh CE4 eGo Clearomizer

Nicotine polacrilex

ACTIVE COMPARATOR

Nicotine Replacement gum

Drug: Nicotine polacrilex

Interventions

Nicotine polacrilex DRUG

2 mg and 4 mg gum will be used according to the FDA approved product labelling

Also known as: Nicotine Gum

Nicotine polacrilex

STAM 1100mAh CE4 eGo Clearomizer OTHER

Also known as: e-Cigarette, electronic nicotine delivery device

e-Cigarette

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Smokes at least five cigarettes per day
• No current or previous regular use of e-cigarettes
• Ready to quit smoking

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Vaping

Interventions

Tobacco Use Cessation Devices; Nicotine Chewing Gum; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Therapeutics; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Creighton University

sandrabyers@creighton.edu

402-280-4961

Study Officials

• Amy J Arouni, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (1)