Predictors and Consequences of Combustible Cigarette Smokers' Switch to Standardized Research E-Cigarettes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The investigators will enroll 120 conventional cigarette smokers who report smoking at least 7 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 by whether they use menthol cigarettes) and randomly assigned with a 1:1 allocation ratio to one of two conditions: 1) nicotine SREC (N = 60); and 2) placebo SREC (N = 60). Both staff and participants will be blind to assignment. 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.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: nicotine SREC The liquid in the e-cigarette refills contains nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. |
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
Other: Nicotine present in the SREC device and refills
Nicotine is present in the liquid in the SREC device and all refills. Two-thirds of the sample will receive nicotine in their SREC; one-third will not (placebo)
|
| Placebo Comparator: placebo SREC The liquid in the e-cigarette refills does not contain nicotine and comes in the following flavors: tobacco, menthol, blueberry, and watermelon. |
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
|
Outcome Measures
Primary Outcome Measures
- Combustible cigarette use [12-weeks (end of treatment)]
number of cigarettes smoked per week
Secondary Outcome Measures
- Abstinence [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)
- Number of cigarettes smoked [18-weeks (end of trial)]
The total number of cigarettes smoked in the 7 days prior to the last assessment
Other Outcome Measures
- CO level [12-weeks]
in ppm
- Blood Pressure [12-weeks]
systolic blood pressure and diastolic blood pressure in mm hg
- Heart Rate [12-weeks]
beats per minute
- Weight [12-weeks]
in pounds
- self-report of respiratory symptoms [12-weeks]
The St. George's Respiratory Questionnaire (SGRQ)
- nicotine dependence [12-weeks]
Fagerstrom Test for Nicotine Dependence
Eligibility Criteria
Criteria
Inclusion Criteria:
-
men and women 21 years of age or older;
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daily smoking rate of 7 cigarettes/day or greater for at least one year;
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interested in reducing cigarette use;
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willing to try e-cigarettes;
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able to attend in-person assessments over the next 5 months;
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English speaking; and
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breath CO of 10ppm 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:
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current use of any smoking cessation medication or participation in a smoking cessation program or study;
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current daily ENDS user;
-
pregnancy if female; and
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no two members of the same household may participate in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Illinois at Chicago
- National Institute on Drug Abuse (NIDA)
- University of Chicago
Investigators
- Principal Investigator: Robin Mermelstein, PhD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-0948
- 1U01DA045524-01