Clinical trial NCT03277495: Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes
Official title: Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Chicago
First posted: 2017-09-11
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Combustible cigarette use
timeFrame: 12-weeks (end of treatment)
Secondary outcomes:
measure: Abstinence
timeFrame: 12-weeks (end of treatment)
measure: Number of cigarettes smoked
timeFrame: 18-weeks (end of trial)
Other outcomes:
measure: CO level
timeFrame: 12-weeks
measure: Blood Pressure
timeFrame: 12-weeks
measure: Heart Rate
timeFrame: 12-weeks
measure: Weight
timeFrame: 12-weeks
measure: self-report of respiratory symptoms
timeFrame: 12-weeks
measure: nicotine dependence
timeFrame: 12-weeks
Locations:
city: Chicago
country: United States
facility: Institute for Health Research and Policy
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Robin Mermelstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: