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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Brief behavioral counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathleen Diviak, PhD; Phone Number: 312-996-2327; Email: kdiviak@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • Institute for Health Research and Policy
      • Contact: Kathleen Diviak, PhD; Phone Number: 312-996-2327; Email: kdiviak@uic.edu
      • Principal Investigator: Robin Mermelstein, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention
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; Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combustible cigarette use	number of cigarettes smoked per week	12-weeks (end of treatment)

Secondary Outcome Measures

Outcome Measure	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	The total number of cigarettes smoked in the 7 days prior to the last assessment	18-weeks (end of trial)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CO level	in ppm	12-weeks
Blood Pressure	systolic blood pressure and 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	The St. George's Respiratory Questionnaire (SGRQ)	12-weeks
nicotine dependence	Fagerstrom Test for Nicotine Dependence	12-weeks

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Drug Abuse (NIDA); University of Chicago
• Investigators: Principal Investigator: Robin Mermelstein, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2017-0948 (Other Identifier: M D Anderson Cancer Center); 1U01DA045524-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No