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

NCT ID: NCT03277495

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-12
• Study Completion Date: 2024-08-14

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Brief behavioral counseling

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Brief behavioral counseling

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Robin Mermelstein

Distinguished Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Mermelstein, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

Institute for Health Research and Policy

Chicago, Illinois, United States

Countries

United States

Other Identifiers

1U01DA045524-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0948

Identifier Type: -

Identifier Source: org_study_id