Nicotine Addiction, Smoking Cessation
Conditions
Keywords
Smoking Cessation, Nicotine Addiction, e-Cigarette, electronic nicotine delivery device, electronic cigarette, nicotine replacement therapy
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.
Interventions
2 mg and 4 mg gum will be used according to the FDA approved product labelling
OTHERSTAM 1100mAh CE4 eGo Clearomizer
Sponsors
Creighton University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Abstinence | 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
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence Abstinence | 12 weeks | No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| e-Cigarette STAM 1100mAh CE4 eGo Clearomizer e-Cigarette | 5 |
| Nicotine Polacrilex Nicotine Replacement gum
Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | e-Cigarette | Total | Nicotine Polacrilex |
|---|---|---|---|
| Age, Continuous | 42 years | 43 years | 44 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 5 participants | 10 participants | 5 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| e-Cigarette | Sustained Abstinence | 0 participants |
| Nicotine Polacrilex | Sustained Abstinence | 1 participants |
Secondary
Point Prevalence Abstinence
No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| e-Cigarette | Point Prevalence Abstinence | 1 participants |
| Nicotine Polacrilex | Point Prevalence Abstinence | 1 participants |