Trial Outcomes & Findings for e-Cigarettes Versus NRT Gum for Smoking Cessation (NCT NCT01925781)

NCT ID: NCT01925781

Last Updated: 2016-01-14

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 10 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-01-14

Participant Flow

Participant milestones

Measure	e-Cigarette STAM 1100mAh CE4 eGo Clearomizer e-Cigarette	Nicotine Polacrilex Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Overall Study STARTED	5	5
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

e-Cigarettes Versus NRT Gum for Smoking Cessation

Baseline characteristics by cohort

Measure	e-Cigarette n=5 Participants STAM 1100mAh CE4 eGo Clearomizer e-Cigarette	Nicotine Polacrilex n=5 Participants Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling	Total n=10 Participants Total of all reporting groups
Age, Continuous	42 years n=5 Participants	44 years n=7 Participants	43 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	e-Cigarette n=3 Participants STAM 1100mAh CE4 eGo Clearomizer e-Cigarette	Nicotine Polacrilex n=1 Participants Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Sustained Abstinence	0 participants	1 participants

SECONDARY outcome

Timeframe: 12 weeks

No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.

Outcome measures

Measure	e-Cigarette n=3 Participants STAM 1100mAh CE4 eGo Clearomizer e-Cigarette	Nicotine Polacrilex n=1 Participants Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Point Prevalence Abstinence	1 participants	1 participants

Adverse Events

e-Cigarette

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nicotine Polacrilex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	e-Cigarette n=5 participants at risk STAM 1100mAh CE4 eGo Clearomizer e-Cigarette	Nicotine Polacrilex n=5 participants at risk Nicotine Replacement gum Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling
Respiratory, thoracic and mediastinal disorders Throat dry/irritated	20.0% 1/5 • Number of events 1	0.00% 0/5

Additional Information

Director of Clinical Trials

Creighton University

Phone: 402-280-4961

Email: sandrabyers@creighton.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place