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CompletedNCT03277495Updated Feb 17, 2026Results posted

Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes

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

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tobacco Use

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03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (actual)

Study arms

  • Active comparator
    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.

    Behavioral: Brief behavioral counseling

  • Active comparator
    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.

    Behavioral: Brief behavioral counseling

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

05

What researchers measure

Primary outcomes

  1. Combustible Cigarette Use

    Number of cigarettes smoked per day in past week

    Time frame: 12-weeks (end of treatment)

Secondary outcomes

  1. 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)

  2. Number of Cigarettes Smoked

    Average 7-day cigarette rate

    Time frame: 18-weeks (end of trial)

Other outcomes

  1. CO Level

    CO level in ppm

    Time frame: 12-weeks

  2. Blood Pressure - Systolic

    Mean systolic blood pressure in mm hg

    Time frame: 12-weeks

  3. Blood Pressure - Diastolic

    Mean diastolic blood pressure in mm hg

    Time frame: 12-weeks

  4. Heart Rate

    beats per minute

    Time frame: 12-weeks

  5. Weight

    in pounds

    Time frame: 12-weeks

  6. 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

  7. 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

06

Results

Posted Feb 17, 2026
Limitations and caveats
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.

Participant flow

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).

Participant flow — Overall Study
MilestoneUsual SREC Pods FlavorChoice of SREC Pods Flavor
Started3030
Completed1924
Not completed116
Withdrew: Withdrawal by subject11
Withdrew: Lost to follow-up43
Withdrew: Assessment window closed62

Outcome measures

PrimaryCombustible Cigarette Use

Number of cigarettes smoked per day in past week

Time frame:
12-weeks (end of treatment)
Reported as:
Mean · Number of cigarettes smoked per day
Combustible Cigarette Use
Number of cigarettes smoked per dayUsual SREC Pods FlavorChoice of SREC Pods Flavors
Combustible Cigarette Use3.79 ± 4.6373.64 ± 4.598
SecondaryAbstinence

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)
Reported as:
Count of participants · Participants
Abstinence
ParticipantsUsual SREC Pods FlavorChoice of SREC Pods Flavors
Abstinence68
SecondaryNumber of Cigarettes Smoked

Average 7-day cigarette rate

Time frame:
18-weeks (end of trial)
Reported as:
Mean · Number of cigarettes
Number of Cigarettes Smoked
Number of cigarettesUsual SREC Pods FlavorChoice of SREC Pods Flavors
Number of Cigarettes Smoked7.73 ± 7.1655.93 ± 3.872
Other pre-specifiedCO Level

CO level in ppm

Time frame:
12-weeks
Reported as:
Mean · ppm
CO Level
ppmUsual SREC Pods FlavorChoice of SREC Pods Flavors
CO Level9.58 ± 10.46910.05 ± 12.512
Other pre-specifiedBlood Pressure - Systolic

Mean systolic blood pressure in mm hg

Time frame:
12-weeks
Reported as:
Mean · mm hg
Blood Pressure - Systolic
mm hgUsual SREC Pods FlavorChoice of SREC Pods Flavors
Blood Pressure - Systolic120.18 ± 15.129120.84 ± 13.668
Other pre-specifiedBlood Pressure - Diastolic

Mean diastolic blood pressure in mm hg

Time frame:
12-weeks
Reported as:
Mean · mm hg
Blood Pressure - Diastolic
mm hgUsual SREC Pods FlavorChoice of SREC Pods Flavors
Blood Pressure - Diastolic79.44 ± 12.58877.83 ± 10.571
Other pre-specifiedHeart Rate

beats per minute

Time frame:
12-weeks
Reported as:
Mean · Beats per minute
Heart Rate
Beats per minuteUsual SREC Pods FlavorChoice of SREC Pods Flavors
Heart Rate80.1140 ± 12.7804477.1167 ± 10.58468
Other pre-specifiedWeight

in pounds

Time frame:
12-weeks
Reported as:
Mean · pounds
Weight
poundsUsual SREC Pods FlavorChoice of SREC Pods Flavors
Weight175.53 ± 34.539196.86 ± 68.425
Other pre-specifiedSelf-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
Reported as:
Mean · scores on a scale
Self-report of Respiratory Symptoms
scores on a scaleUsual SREC Pods FlavorChoice of SREC Pods Flavors
Self-report of Respiratory Symptoms2.5789 ± 1.518531.6250 ± 0.76279
Other pre-specifiedNicotine 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
Reported as:
Mean · scores on a scale
Nicotine Dependence
scores on a scaleUsual SREC Pods FlavorChoice of SREC Pods Flavors
Nicotine Dependence4.23 ± 2.4213.53 ± 2.183

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Usual SREC Pods Flavor1/30 (3.3%)1/30 (3.3%)17/30 (56.7%)
Choice of SREC Pods Flavors0/30 (0%)2/30 (6.7%)16/30 (53.3%)
Most frequent serious events
Most frequent serious events
EventUsual SREC Pods FlavorChoice of SREC Pods Flavors
HospitalizationEndocrine disorders0/301/30
HospitalizationGeneral disorders0/301/30
DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/300/30
Most frequent other events
Most frequent other events
EventUsual SREC Pods FlavorChoice of SREC Pods Flavors
CoughRespiratory, thoracic and mediastinal disorders11/3011/30
Throat problemsGastrointestinal disorders5/308/30
Shortness of breathRespiratory, thoracic and mediastinal disorders7/305/30
HeadacheNervous system disorders6/307/30
NauseaGastrointestinal disorders5/303/30
Mouth ProblemsGastrointestinal disorders5/300/30
DizzinessGeneral disorders3/303/30
DiarrheaGastrointestinal disorders3/301/30
SweatingNervous system disorders2/302/30

Baseline characteristics

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
Age, Continuous(years)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Mean42.06 ± 13.11047.65 ± 10.75744.81 ± 12.241
Sex: Female, Male
Sex: Female, Male(Participants)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Female121224
Male201939
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
American Indian or Alaska Native101
Asian415
Native Hawaiian or Other Pacific Islander101
Black or African American101626
White151429
More than one race101
Unknown or Not Reported000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Hispanic or Latino628
Not Hispanic or Latino212849
Unknown or Not Reported516
Combustible cigarette use
Combustible cigarette use(Number of cigarettes smoked per day)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Mean11.53 ± 7.11214.16 ± 16.90612.83 ± 12.858
Abstinence
Abstinence(Participants)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Count of participants000
CO level
CO level(ppm)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Mean16.38 ± 11.08522.71 ± 17.08619.49 ± 14.591
Blood Pressure - Systolic
Blood Pressure - Systolic(mm hg)Usual SREC Pods FlavorChoice of SREC Pods FlavorsTotal
Mean115.8281 ± 17.971116.9500 ± 20.582116.37 ± 19.127

5 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Institute for Health Research and Policy
    Chicago, Illinois 60608, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · May 16, 2023
  • Informed consent form · May 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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, Sap, Icf, Csr, Analytic code

09

Registry details

Key details

Study ID
NCT03277495
Lead sponsor
University of Illinois at Chicago
Collaborators
National Institute on Drug Abuse (NIDA), University of Chicago
Responsible party
Robin Mermelstein (Distinguished Professor and Director, University of Illinois at Chicago) — Principal investigator
First posted
Sep 11, 2017
Start date
Jul 12, 2023
Primary completion
Aug 14, 2024
Completion
Aug 14, 2024
Results posted
Feb 17, 2026
Last update
Feb 17, 2026

Study contacts

Robin Mermelstein, PhD
principal investigator · University of Illinois at Chicago

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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