An interventional study of Brief behavioral counseling in Tobacco Use, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment
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Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.
Among the 311 studies in Tobacco Use with a site in United States, this one is the 189th largest by enrollment of the 286 interventional ones that give a count, is one of 21 that started in 2023, is one of 231 with no phase, and was the 96th registered.
421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.
Browse Tobacco Use studies →52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 18+
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 18+ · Women only
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.
This study: 21 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
311 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 22 · Phase 3 10 · Phase 4 9
First in 1992; this study’s year is marked. 21 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 63 is below the median of 127 across 352 interventional studies indexed under Tobacco Use.
Median enrollment 120 across the 286 interventional studies, 174 across the 24 observational. Of the 232 that completed or were terminated, 82 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 311 have an industry lead sponsor. The 10 most frequent:
University of Illinois at Chicago is the lead sponsor of 504 studies on the registry; 119 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
University of Illinois at Chicago has 1 study filed under Tobacco Use — fewer than ten, so there is no comparison to draw.
30 of the studies in Tobacco Use with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
| NCT07710820RAI Services CompanyA Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07598136RAI Services CompanyA Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers | 2026-12-17 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
Add all 30 to your calendar (.ics) → With an account.
Among the 311 studies in Tobacco Use with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Brief behavioral counseling
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.
Behavioral: Brief behavioral counseling
Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention
Combustible Cigarette Use
Number of cigarettes smoked per day in past week
Time frame: 12-weeks (end of treatment)
Abstinence
The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)
Time frame: 12-weeks (end of treatment)
Number of Cigarettes Smoked
Average 7-day cigarette rate
Time frame: 18-weeks (end of trial)
CO Level
CO level in ppm
Time frame: 12-weeks
Blood Pressure - Systolic
Mean systolic blood pressure in mm hg
Time frame: 12-weeks
Blood Pressure - Diastolic
Mean diastolic blood pressure in mm hg
Time frame: 12-weeks
Heart Rate
beats per minute
Time frame: 12-weeks
Weight
in pounds
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks
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).
| Milestone | Usual SREC Pods Flavor | Choice of SREC Pods Flavor |
|---|---|---|
| Started | 30 | 30 |
| Completed | 19 | 24 |
| Not completed | 11 | 6 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Assessment window closed | 6 | 2 |
Number of cigarettes smoked per day in past week
| Number of cigarettes smoked per day | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Combustible Cigarette Use | 3.79 ± 4.637 | 3.64 ± 4.598 |
The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)
| Participants | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Abstinence | 6 | 8 |
Average 7-day cigarette rate
| Number of cigarettes | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Number of Cigarettes Smoked | 7.73 ± 7.165 | 5.93 ± 3.872 |
CO level in ppm
| ppm | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| CO Level | 9.58 ± 10.469 | 10.05 ± 12.512 |
Mean systolic blood pressure in mm hg
| mm hg | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Blood Pressure - Systolic | 120.18 ± 15.129 | 120.84 ± 13.668 |
Mean diastolic blood pressure in mm hg
| mm hg | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Blood Pressure - Diastolic | 79.44 ± 12.588 | 77.83 ± 10.571 |
beats per minute
| Beats per minute | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Heart Rate | 80.1140 ± 12.78044 | 77.1167 ± 10.58468 |
in pounds
| pounds | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Weight | 175.53 ± 34.539 | 196.86 ± 68.425 |
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.
| scores on a scale | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Self-report of Respiratory Symptoms | 2.5789 ± 1.51853 | 1.6250 ± 0.76279 |
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.
| scores on a scale | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| Nicotine Dependence | 4.23 ± 2.421 | 3.53 ± 2.183 |
Collected over From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual SREC Pods Flavor | 1/30 (3.3%) | 1/30 (3.3%) | 17/30 (56.7%) |
| Choice of SREC Pods Flavors | 0/30 (0%) | 2/30 (6.7%) | 16/30 (53.3%) |
| Event | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| HospitalizationEndocrine disorders | 0/30 | 1/30 |
| HospitalizationGeneral disorders | 0/30 | 1/30 |
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/30 | 0/30 |
| Event | Usual SREC Pods Flavor | Choice of SREC Pods Flavors |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 11/30 | 11/30 |
| Throat problemsGastrointestinal disorders | 5/30 | 8/30 |
| Shortness of breathRespiratory, thoracic and mediastinal disorders | 7/30 | 5/30 |
| HeadacheNervous system disorders | 6/30 | 7/30 |
| NauseaGastrointestinal disorders | 5/30 | 3/30 |
| Mouth ProblemsGastrointestinal disorders | 5/30 | 0/30 |
| DizzinessGeneral disorders | 3/30 | 3/30 |
| DiarrheaGastrointestinal disorders | 3/30 | 1/30 |
| SweatingNervous system disorders | 2/30 | 2/30 |
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.
| Age, Continuous(years) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Mean | 42.06 ± 13.110 | 47.65 ± 10.757 | 44.81 ± 12.241 |
| Sex: Female, Male(Participants) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 20 | 19 | 39 |
| Race (NIH/OMB)(Participants) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 10 | 16 | 26 |
| White | 15 | 14 | 29 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 2 | 8 |
| Not Hispanic or Latino | 21 | 28 | 49 |
| Unknown or Not Reported | 5 | 1 | 6 |
| Combustible cigarette use(Number of cigarettes smoked per day) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Mean | 11.53 ± 7.112 | 14.16 ± 16.906 | 12.83 ± 12.858 |
| Abstinence(Participants) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
| CO level(ppm) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Mean | 16.38 ± 11.085 | 22.71 ± 17.086 | 19.49 ± 14.591 |
| Blood Pressure - Systolic(mm hg) | Usual SREC Pods Flavor | Choice of SREC Pods Flavors | Total |
|---|---|---|---|
| Mean | 115.8281 ± 17.971 | 116.9500 ± 20.582 | 116.37 ± 19.127 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 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.
Access criteria: 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.
Ran from Jul 2023 to primary completion in Aug 2024, 13 months.
Results were first posted in Feb 2026, 1 year 6 months after primary completion.
Of 167 non-industry interventional studies with no phase under Tobacco Use, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 13 months is below that.
Counting every sponsor, half of 223 studies reached it within 16 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago →