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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DA045524-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Chicago | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual SREC pods Flavor | Active Comparator | The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor. |
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| Choice of SREC pods Flavors | Active Comparator | The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief behavioral counseling | Behavioral | Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Combustible Cigarette Use | Number of cigarettes smoked per day in past week | 12-weeks (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days) | 12-weeks (end of treatment) |
| Number of Cigarettes Smoked |
| Measure | Description | Time Frame |
|---|---|---|
| CO Level | CO level in ppm | 12-weeks |
| Blood Pressure - Systolic | Mean systolic blood pressure in mm hg | 12-weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Mermelstein, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Health Research and Policy | Chicago | Illinois | 60608 | United States |
Within two years after the final data collection is completed, the investigators will create a completely de-identified data set will that obfuscate any variable that might potentially be used to identify an individual study participant. Data collection instruments, codebooks, and other data documentation will be made available in conjunction with this dataset in a standard format that is readable across a variety of applications and operating system platforms.
Data will become available no later than two years after the final data collection is completed. There is no time frame identified for stopping the sharing of the data.
A data sharing agreement will be required for release of any data. Individuals requesting a copy of study data will need to submit a detailed research plan that includes the purpose of the proposed research, the variables required, the duration of the analysis phase, IRB approval with FWA information, investigator training in human subjects and other approvals specific to the individual datasets. They will also be required to submit a Data Protection Plan or Institutional Privacy Policy, describing the computing environment in which data will be managed and analyzed and how physical access to computing equipment will be controlled. Data will only be released once all IRB approvals and Human Subjects concerns have been addressed.
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual SREC Pods Flavor | The liquid in the e-cigarette refills contained nicotine and came in either tobacco or menthol. Participants in this condition received SREC pods in their usual cigarette flavor. Those who smoked menthol received only menthol pods and those who smoked regular cigarettes received tobacco pods. |
| FG001 | Choice of SREC Pods Flavor | The liquid in the e-cigarette refills contained nicotine and came in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant received SREC pods in their choice of flavor. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data collected for all participants who provided consent to participate in the study and completed their baseline visit prior to randomized assignment to intervention groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual SREC Pods Flavor | The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor. |
| BG001 | Choice of SREC Pods Flavors |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean age in years | Participants who completed the baseline visit prior to randomization |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combustible Cigarette Use | Number of cigarettes smoked per day in past week | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | Number of cigarettes smoked per day | 12-weeks (end of treatment) |
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From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks
Participants completed an adverse events questionnaire at every visit and staff also collected data if participants reported information between visits during appointment reminder phone calls.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual SREC Pods Flavor | The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their usual flavor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Endocrine disorders | Systematic Assessment | short term hospitalization for diabetes management; not at all related to the SREC |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 83% of cough reports were categorized as mild. 75% were deemed unrelated to SREC use (e.g., illness, seasonal allergies, etc.) |
Our ability to detect differences by treatment condition was hindered by the relatively small sample size and challenges with recruitment. Although participants in the Flavor Choice condition did take and sample multiple flavors, some were concerned about the policy context surrounding flavors and e-cigarettes given that Chicago (study site) had banned flavored e-cigarettes, and they did not want to use a product that they would not be able to obtain legally after the study was over.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robin Mermelstein | University of Illinois Chicago | 3129961469 | robinm@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2023 | Jan 6, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | Jan 6, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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).
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Average 7-day cigarette rate
| 18-weeks (end of trial) |
| Blood Pressure - Diastolic | Mean diastolic blood pressure in mm hg | 12-weeks |
| Heart Rate | beats per minute | 12-weeks |
| Weight | in pounds | 12-weeks |
| Self-report of Respiratory Symptoms | Self-reported respiratory health was measured by computing the average of four items designed to assess severity of respiratory symptoms including: cough, phlegm production, shortness of breath, and irritation in throat and lungs. Participants rated each symptom on a scale from 1 (None) to 10 (Severe) with higher total scores indicating more severe respiratory health problems. | 12-weeks |
| Nicotine Dependence | Nicotine dependence was measured using the Fagerstrom Test for Nicotine Dependence (FTND). Total scores calculated using the sum of six items and can range from 0 to 12 with higher scores indicating higher nicotine dependence. | 12-weeks |
| Assessment Window Closed |
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The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex: Female, Male | Participant Sex, Female or Male | Participants who completed the baseline visit prior to randomization | Count of Participants | Participants |
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| Race (NIH/OMB) | Participant Race | Participants who completed the baseline visit prior to randomization | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Participant Ethnicity | Participants who completed the baseline visit prior to randomization | Count of Participants | Participants |
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| Combustible cigarette use | Number of cigarettes smoked per day in past week | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | Number of cigarettes smoked per day |
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| Abstinence | The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days) | Participants who completed the baseline visit prior to randomization | Count of Participants | Participants |
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| CO level | CO level in ppm | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | ppm |
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| Blood Pressure - Systolic | Mean systolic blood pressure in mm hg | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | mm hg |
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| Blood Pressure - Diastolic | Mean diastolic blood pressure in mm hg | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | mm hg |
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| Heart Rate | beats per minute | Participants who completed the baseline visit and heart rate was collected N = 31 Usual SREC pods Flavor; N = 30 Choice of SREC pods Flavors. Missing cases were attributed equipment malfunction or participant refusal. | Mean | Standard Deviation | Beats per minute |
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| Weight | Weight in pounds | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | pounds |
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| nicotine dependence | Nicotine dependence was measured using the Fagerstrom Test for Nicotine Dependence (FTND). Total scores calculated using the sum of six items and can range from 0 to 12 with higher scores indicating higher nicotine dependence. | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | scores on a scale |
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| self-report of respiratory symptoms | Self-reported respiratory health was measured by computing the average of four items designed to assess severity of respiratory symptoms including: cough, phlegm production, shortness of breath, and irritation in throat and lungs. Participants rated each symptom on a scale from 1 (None) to 10 (Severe) with higher total scores indicating more severe respiratory health problems. | Anyone who completed the baseline visit prior to randomization | Mean | Standard Deviation | scores on a scale |
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| Secondary | Abstinence | The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days) | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Count of Participants | Participants | 12-weeks (end of treatment) |
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| Secondary | Number of Cigarettes Smoked | Average 7-day cigarette rate | All participants who completed the follow up period at Week 18 | Posted | Mean | Standard Deviation | Number of cigarettes | 18-weeks (end of trial) |
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| Other Pre-specified | CO Level | CO level in ppm | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | ppm | 12-weeks |
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| Other Pre-specified | Blood Pressure - Systolic | Mean systolic blood pressure in mm hg | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | mm hg | 12-weeks |
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| Other Pre-specified | Blood Pressure - Diastolic | Mean diastolic blood pressure in mm hg | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | mm hg | 12-weeks |
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| Other Pre-specified | Heart Rate | beats per minute | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | Beats per minute | 12-weeks |
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| Other Pre-specified | Weight | in pounds | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | pounds | 12-weeks |
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| Other Pre-specified | Self-report of Respiratory Symptoms | Self-reported respiratory health was measured by computing the average of four items designed to assess severity of respiratory symptoms including: cough, phlegm production, shortness of breath, and irritation in throat and lungs. Participants rated each symptom on a scale from 1 (None) to 10 (Severe) with higher total scores indicating more severe respiratory health problems. | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
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| Other Pre-specified | Nicotine Dependence | Nicotine dependence was measured using the Fagerstrom Test for Nicotine Dependence (FTND). Total scores calculated using the sum of six items and can range from 0 to 12 with higher scores indicating higher nicotine dependence. | All participants who received at least one dose of SREC and completed the EOT visit at Week 14 | Posted | Mean | Standard Deviation | scores on a scale | 12-weeks |
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| 1 |
| 30 |
| 1 |
| 30 |
| 17 |
| 30 |
| EG001 | Choice of SREC Pods Flavors | The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. The participant will receive SREC pods in their choice of flavor. | 0 | 30 | 2 | 30 | 16 | 30 |
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| Hospitalization | General disorders | Non-systematic Assessment | unknown, participant declined to provide details to staff and did not return for any additional in-person visits |
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| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Participant had a cancer diagnosis and surgery prior to enrollment; death was not related to SREC use |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 89% of reports were categorized as mild. 79% were deemed unrelated to SREC use (e.g., illness, seasonal allergies, etc.) |
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| Headache | Nervous system disorders | Systematic Assessment | 50% of reports were categorized as mild. 72% were deemed unrelated to SREC use (e.g., illness, seasonal allergies, stress, etc.) |
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| Throat problems | Gastrointestinal disorders | Systematic Assessment | 69% of reports were categorized as mild. 56% were deemed unrelated to SREC use (e.g., illness, allergies, cigarette smoking, etc.) |
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| Nausea | Gastrointestinal disorders | Systematic Assessment | 70% of reports were categorized as mild. 50% were deemed unrelated to SREC use (e.g., illness, seasonal allergies, side effects of other medications, etc.) |
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| Mouth Problems | Gastrointestinal disorders | Systematic Assessment | 86% of reports were categorized as mild or moderate. 50% were deemed unrelated to SREC use (e.g., dental problem, illness, allergies, etc.) |
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| Dizziness | General disorders | Systematic Assessment | 71% of reports were categorized as mild. 66% were deemed unrelated to SREC use (e.g., illness, other medications, etc.) |
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| Sweating | Nervous system disorders | Systematic Assessment | 83% of reports were categorized as mild. 79% were deemed unrelated to SREC use (e.g., illness, known side effect of another medication, physical demands of job, etc.) |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | 50% of reports were categorized as mild. 100% were deemed unrelated to SREC use (e.g., illness, food poisoning, etc.) |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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