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Completed

NCT Number: NCT03277495

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

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.

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Health Research and Policy

Chicago, Illinois, 60608, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Combustible Cigarette Use

    Time frame: 12-weeks (end of treatment)

    Number of cigarettes smoked per day in past week

Secondary outcomes

  1. Abstinence

    Time frame: 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)

  2. Number of Cigarettes Smoked

    Time frame: 18-weeks (end of trial)

    Average 7-day cigarette rate

Other outcomes

  1. CO Level

    Time frame: 12-weeks

    CO level in ppm

  2. Blood Pressure - Systolic

    Time frame: 12-weeks

    Mean systolic blood pressure in mm hg

  3. Blood Pressure - Diastolic

    Time frame: 12-weeks

    Mean diastolic blood pressure in mm hg

  4. Heart Rate

    Time frame: 12-weeks

    beats per minute

  5. Weight

    Time frame: 12-weeks

    in pounds

  6. Self-report of Respiratory Symptoms

    Time frame: 12-weeks

    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.

  7. Nicotine Dependence

    Time frame: 12-weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Chicago

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 11, 2017
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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