Nicotine Dependence, Nicotine Dependence, Other Tobacco Product, Smoking
Conditions
Keywords
smoking, nicotine, tobacco products, electronic cigarette
Brief summary
The purpose of this study is to examine cigarette smokers' use of electronic cigarettes (e-cigarettes), and how use of e-cigarettes affects short term smoking behavior.
Detailed description
Study initiation will commence after the first telephone contact (phone pre-screen), at the baseline visit. Additional lab visits will occur at days 8, 15, and 22 (visits 2-4). At the first study visit, 2/3rds of the participants will be randomly assigned to sample e-cigarettes and 1/3rd will not. Participants in the e-cigarette group will be provided with sufficient product to sample and use as they wish, but with minimal instruction on purpose and level of use (non-use is an outcome). Smokers in the control group will smoke their own brand of cigarettes, as they wish, for the duration of the sampling period. All participants will engage in ecological momentary assessments, which will be completed 3 times daily for 3 weeks. In-person follow-up assessments will be conducted at 1, 2, and 3 months after the final lab visit (Day 22). Overall, each participant will be contacted 8 times: at the phone pre-screening, the 4 lab visits, and 3 follow-up visits.
Interventions
OTHERelectronic cigarette
OTHERcigarette group
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18+ * current smoker of at least 5 cigarettes per day for at least 1 year * at least some concern for health effects of smoking * having an easily accessible email address
Exclusion criteria
* past six month use of any e-cigarette * lifetime ever purchase of any e-cigarette * recent history of cardiovascular distress (heart attack in past year; arrhythmia; uncontrolled hypertension) * recent history (past 3 months) of Chronic Obstructive Pulmonary Disease (COPD), cancer (any non-dermatologic), or uncontrolled diabetes mellitus * pregnant or breastfeeding * any major current psychiatric impairment, including current alcohol/drug abuse/dependence * use of non-cigarette tobacco products (e.g., cigarillos) in the last 30 days * current use of any smoking cessation medications * current enrollment in a smoking cessation treatment study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of Electronic Nicotine Delivery Systems (ENDS) | study week 16 | % of participants by group used e-cigarettes in week 16 |
| Independent Purchase of an ENDs Product | study enrollment to study week 16 | % of participants by group who purchased an ENDs product on their own during the study |
| % Quit Attempts | study enrollment to study week 16 | % of participants who made any quit attempt during study |
| Point Prevalence Abstinence | week 16 | % of participants with CO-verified cigarette abstinence at study week 16 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 16 mg Electronic Nicotine Delivery Systems (ENDS) Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. | 25 |
| 24 mg Electronic Nicotine Delivery Systems (ENDS) Study Participants were randomized in a 2:1 ratio to receive electronic nicotine delivery systems (ENDS) or not.
Changes in product design, i.e., improved nicotine delivery (16mg vs. 24mg), midway through the study allowed the unexpected but compelling opportunity to examine two ENDS products compared to control group. | 21 |
| Control Group This group (1/3 of the sample) did not receive electronic cigarettes to sample and continued smoking their regular cigarettes as much or as little as they chose. | 22 |
| Total | 68 |
Baseline characteristics
| Characteristic | 24 mg Electronic Nicotine Delivery Systems (ENDS) | Control Group | 16 mg Electronic Nicotine Delivery Systems (ENDS) | Total |
|---|---|---|---|---|
| Age, Continuous | 40.9 years STANDARD_DEVIATION 12.3 | 42.3 years STANDARD_DEVIATION 14.2 | 43.3 years STANDARD_DEVIATION 14.4 | 42.2 years STANDARD_DEVIATION 13.6 |
| Race/Ethnicity, Customized Race Black or African American | 11 Participants | 9 Participants | 10 Participants | 30 Participants |
| Race/Ethnicity, Customized Race Multiracial | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 10 Participants | 13 Participants | 14 Participants | 37 Participants |
| Region of Enrollment United States | 21 participants | 22 participants | 25 participants | 68 participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 18 Participants | 41 Participants |
| Sex: Female, Male Male | 12 Participants | 8 Participants | 7 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 25 | 0 / 22 |
| other Total, other adverse events | 11 / 21 | 9 / 25 | 8 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 25 | 0 / 22 |
Outcome results
Primary
Independent Purchase of an ENDs Product
% of participants by group who purchased an ENDs product on their own during the study
Time frame: study enrollment to study week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24 mg Electronic Nicotine Delivery Systems (ENDS) | Independent Purchase of an ENDs Product | 57 percentage of participants |
| 16 mg Electronic Nicotine Delivery Systems (ENDS) | Independent Purchase of an ENDs Product | 28 percentage of participants |
| Control Group | Independent Purchase of an ENDs Product | 14 percentage of participants |
Primary
Point Prevalence Abstinence
% of participants with CO-verified cigarette abstinence at study week 16
Time frame: week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24 mg Electronic Nicotine Delivery Systems (ENDS) | Point Prevalence Abstinence | 9.5 percentage of participants |
| 16 mg Electronic Nicotine Delivery Systems (ENDS) | Point Prevalence Abstinence | 4.0 percentage of participants |
| Control Group | Point Prevalence Abstinence | 4.6 percentage of participants |
Primary
% Quit Attempts
% of participants who made any quit attempt during study
Time frame: study enrollment to study week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24 mg Electronic Nicotine Delivery Systems (ENDS) | % Quit Attempts | 47.6 percentage of participants |
| 16 mg Electronic Nicotine Delivery Systems (ENDS) | % Quit Attempts | 40 percentage of participants |
| Control Group | % Quit Attempts | 27.3 percentage of participants |
Primary
Uptake of Electronic Nicotine Delivery Systems (ENDS)
% of participants by group used e-cigarettes in week 16
Time frame: study week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 24 mg Electronic Nicotine Delivery Systems (ENDS) | Uptake of Electronic Nicotine Delivery Systems (ENDS) | 57.14 percentage of participants |
| 16 mg Electronic Nicotine Delivery Systems (ENDS) | Uptake of Electronic Nicotine Delivery Systems (ENDS) | 32 percentage of participants |
| Control Group | Uptake of Electronic Nicotine Delivery Systems (ENDS) | 13.64 percentage of participants |