Tobacco UseNCT03277495

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

A study testing Brief behavioral counseling in people with Tobacco Use, run by University of Illinois Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Tobacco Use
What is being tested?: Brief behavioral counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2023to 14 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

men and women 21 years of age or older;
daily smoking rate of 3 cigarettes/day or greater for at least one year;
interested in reducing cigarette use;
willing to try e-cigarettes;
able to attend in-person assessments over the next 5 months;
English speaking; and
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.

Who cannot join

current use of any smoking cessation medication or participation in a smoking cessation program or study;
current daily ENDS user;
pregnancy if female; and
no two members of the same household may participate in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Institute for Health Research and Policy
Chicago, Illinois, 60608

Other trials in United States

About this study

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.

Conditions: Tobacco Use
Being tested: Brief behavioral counseling
Medical subject headings: Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brief behavioral counselingBehavioural
Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention

Study groups in NCT03277495
Study group	Role	What they receive
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. Receives: Behavioral: Brief behavioral counseling
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. Receives: Behavioral: Brief behavioral counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Combustible Cigarette Use
Number of cigarettes smoked per day in past week
Measured: 12-weeks (end of treatment)

Secondary outcomes (2)

Abstinence
The proportion of participants who achieve total abstinence from combustible cigarettes (defined as no cigarette smoking in the past 7 days)
Measured: 12-weeks (end of treatment)
Number of Cigarettes Smoked
Average 7-day cigarette rate
Measured: 18-weeks (end of trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 202314 Aug 2024

First posted11 Sep 2017
Study start12 Jul 2023
Primary completion14 Aug 2024
Study completion14 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco UseStudies of the same condition, open and under way.
More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03277495
Sponsor's protocol ID: 2017-0948
Other IDs: 1U01DA045524-01
Status last verified: Jan 2026
First submitted: 7 Sep 2017
Last updated: 17 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Use trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes
ClinicalTrials.gov ID: NCT03277495
Acronym / sponsor ID: 2017-0948
Conditions: Tobacco Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: University of Illinois ChicagoUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of Chicago
Study start: 12 Jul 2023 (actual)
Primary completion: 14 Aug 2024 (actual)
Study completion: 14 Aug 2024 (actual)
First posted: 11 Sep 2017 (actual)
Results: Posted 17 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Week 18 (One Month Follow-up). Participants complete a final survey.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Usual SREC pods Flavor	Active comparator	Behavioral: Brief behavioral counselingThe 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.
Choice of SREC pods Flavors	Active comparator	Behavioral: Brief behavioral counselingThe 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

men and women 21 years of age or older;
daily smoking rate of 3 cigarettes/day or greater for at least one year;
interested in reducing cigarette use;
willing to try e-cigarettes;
able to attend in-person assessments over the next 5 months;

Key exclusion criteria (4 listed)

current use of any smoking cessation medication or participation in a smoking cessation program or study;
current daily ENDS user;
pregnancy if female; and
no two members of the same household may participate in this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brief behavioral counselingStaff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention	Behavioural	Choice of SREC pods Flavors, Usual SREC pods Flavor

Primary outcome

Combustible Cigarette Use
Time frame: 12-weeks (end of treatment)
Number of cigarettes smoked per day in past week

2 secondary outcomes

Abstinence
Time frame: 12-weeks (end of treatment)
Number of Cigarettes Smoked
Time frame: 18-weeks (end of trial)

Results and safety

Results posted to the registry on 17 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual SREC Pods Flavor	30	19
Choice of SREC Pods Flavor	30	24

Primary outcome: Combustible Cigarette Use

Time frame: 12-weeks (end of treatment). Mean (Standard Deviation). Unit: Number of cigarettes smoked per day

Measure	Usual SREC Pods Flavor n = 19	Choice of SREC Pods Flavors n = 22
Value	3.79 (4.637)	3.64 (4.598)

Population analysed: All participants who received at least one dose of SREC and completed the EOT visit at Week 14

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the start of treatment until the last in-person visit/End of treatment for a total of 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual SREC Pods Flavor	1 of 30 (3.3%)	17 of 30 (56.7%)	1 of 30
Choice of SREC Pods Flavors	2 of 30 (6.7%)	16 of 30 (53.3%)	0 of 30

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robin Mermelstein, PhD principal investigator

University of Illinois Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brief behavioral counseling in people with Tobacco Use, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combustible Cigarette Use (time frame: 12-weeks (end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03277495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.