Tobacco Use
Conditions
Brief summary
The primary goal of this study is to examine whether cigarette smokers can reduce their use of conventional, combustible cigarettes by switching to a Standardized Research E-Cigarette (SREC); whether participants can maintain these reductions and use of SRECs over a 12-week period; and whether there are changes in subjective and objective measures of health, appeal and acceptability of the products used during this time frame.
Detailed description
The investigators will enroll 120 conventional cigarette smokers who report smoking at least 3 cigarettes/day. Following completion of baseline questionnaires and a week of ecological momentary assessments (EMA) tracking participants usual smoking behavior, participants will be stratified (by sex) and randomly assigned with a 1:1 allocation ratio to one of two conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC pods in their choice of flavor (N = 60). The SREC pods used in this study come in tobacco, menthol, blueberry, and watermelon flavors. No other flavors will be available to use with the SREC. Counseling at Week 2. Participants in both conditions will receive brief behavioral counseling on reducing their combustible cigarette use by substitution with SREC. Staff will work with participants to set individual goals for reduction during this first week, with the goal of achieving at least 75% reduction in the number of combustible cigarettes smoked by the end of the week, and all are encouraged to reduce further. Participants will also be told not to use any other combustible tobacco products. During the week, participants will complete a daily text or web report on number of cigarettes smoked and SREC pods used. Week 3 Visit. Participants will bring back all used and unused pods for adherence counts, complete a brief questionnaire about subjective reactions and potential adverse effects, and provide breath CO. Participants will meet with study staff to review their progress with switching to SREC and receive continued behavioral counseling to substitute SREC for cigarettes. Participants will receive SREC refill pods and will start a second 7-day EMA protocol. Week 4 Visit. EMA debriefing to check for compliance and any problem reports; return of used and unused pods, complete assessments; review of progress with switching to SREC. Participants will receive a 2 week supply of SREC pods. Weeks 5-13. Participants return to the study office every 2 weeks to return pods, receive a new supply, and provide breath CO. During the week, participants will continue daily use reports via web/text. Week 14 (End-of-Treatment). Participants return to the study office to complete a full assessment battery. They will be encouraged to continue to stay off/reduce all combustible cigarettes, but will not receive additional SREC refills from the study. Week 18 (One Month Follow-up). Participants complete a final survey.
Interventions
BEHAVIORALBrief behavioral counseling
Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention
Sponsors
University of Illinois at Chicago
National Institute on Drug Abuse (NIDA)
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be stratified by sex and randomly assigned with a 1:1 allocation ratio to one of two conditions: 1) to receive SREC pods in their usual flavor (N = 60); and 2) to receive SREC pods in their choice of flavor (N = 60).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. men and women 21 years of age or older; 2. daily smoking rate of 3 cigarettes/day or greater for at least one year; 3. interested in reducing cigarette use; 4. willing to try e-cigarettes; 5. able to attend in-person assessments over the next 5 months; 6. English speaking; and 7. breath CO of 3ppm or greater (assessed at baseline visit). Women who are of child-bearing age cannot be pregnant and must agree to use an approved form of birth control during the study.
Exclusion criteria
1. current use of any smoking cessation medication or participation in a smoking cessation program or study; 2. current daily ENDS user; 3. pregnancy if female; and 4. no two members of the same household may participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combustible Cigarette Use | 12-weeks (end of treatment) | Number of cigarettes smoked per day in past week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence | 12-weeks (end of treatment) | The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days) |
| Number of Cigarettes Smoked | 18-weeks (end of trial) | Average 7-day cigarette rate |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobin Mermelstein, PhD
University of Illinois at Chicago
Participant flow
Recruitment details
We screened 726 individuals and enrolled a sample of 63 smokers who completed the baseline questionnaire and started their first week of the ecological momentary assessment (EMA).
Pre-assignment details
Randomization to the treatment arm occurred after participants completed the initial week of the EMA. Three individuals were dropped before randomization because of failure to complete and return the EMA data collection device and to return for the in-person visit. Sixty participants were thus randomized to the two treatment arms, with 30 randomized to the Usual Flavor condition and 30 to the Flavor Choice condition.
Baseline characteristics
| Characteristic | — |
|---|---|
| Abstinence | 0 Participants |
| Age, Continuous | 42.06 years STANDARD_DEVIATION 13.11 |
| Blood Pressure - Diastolic | 78.2667 mm hg STANDARD_DEVIATION 15.048 |
| Blood Pressure - Systolic | 116.37 mm hg STANDARD_DEVIATION 19.127 |
| CO level | 16.38 ppm STANDARD_DEVIATION 11.085 |
| Combustible cigarette use | 12.83 Number of cigarettes smoked per day STANDARD_DEVIATION 12.858 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Heart Rate | 77.6889 Beats per minute STANDARD_DEVIATION 13.96347 |
| nicotine dependence | 6.2 scores on a scale STANDARD_DEVIATION 1.57268 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| self-report of respiratory symptoms | 3.1210 scores on a scale STANDARD_DEVIATION 1.99465 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight | 193.81 pounds STANDARD_DEVIATION 54.718 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 |
| other Total, other adverse events | 17 / 30 | 16 / 30 |
| serious Total, serious adverse events | 1 / 30 | 2 / 30 |
Outcome results
None listed