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

NCT03277495 | Completed Results

• 2 other identifiers: 2017-09481U01DA045524-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Combustible Cigarette Use

  Number of cigarettes smoked per day in past week

  12-weeks (end of treatment)

Secondary Outcomes (2)

• Abstinence

  12-weeks (end of treatment)

• Number of Cigarettes Smoked

  18-weeks (end of trial)

Other Outcomes (7)

• CO Level

  12-weeks

• Blood Pressure - Systolic

  12-weeks

• Blood Pressure - Diastolic

  12-weeks

Study Arms (2)

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.

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.

Behavioral: Brief behavioral counseling

Interventions

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

Choice of SREC pods Flavors; Usual SREC pods Flavor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Chicago: collaborator
• University of Illinois at Chicago: lead

Study Sites (1)

Institute for Health Research and Policy

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

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.

Results Point of Contact

• Title: Dr. Robin Mermelstein
• Organization: University of Illinois Chicago

robinm@uic.edu

3129961469

Study Officials

• Robin Mermelstein, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor and Director

Model Details: 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).

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: July 12, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: February 17, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)