Status:
COMPLETED
A Study of Unfiltered Cigarettes Among Committed Smokers
Lead Sponsor:
San Diego State University
Collaborating Sponsors:
California State University, San Marcos
Tobacco Related Disease Research Program
Conditions:
Cigarette Smoking
Tobacco Smoking
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes There will be a 1-wee...
Detailed Description
This innovative research project will assess the acceptability among committed smokers of switching to unfiltered cigarettes from filtered cigarettes and compare the measurement of exposure to nicotin...
Eligibility Criteria
Inclusion
- Are non-institutionalized, and
- Able to provide informed consent, and
- Are ages 21 to 65, and
- Smoke at least 25 days per month, and
- Smoke at least 5 cigarettes per day on the days they smoke, and
- Have been smoking cigarettes for at least 1 year, and
- Have smoked exclusively Camel or Pall Mall cigarettes over the past two weeks, or are willing to do so for the two weeks prior to, and for seven weeks during, the study, and
- Are fluent in English, and
- Have regular access to a telephone, and
- Have smoked only filtered cigarettes for the past year, and
- Have access to transportation to California State University, San Marcos (CSUSM), and
- Report primary (≥50% of the time) smoking of cigarettes, allowing for secondary use of other tobacco products, and
- Agree to the terms of the trial
Exclusion
- Do not meet one or more of the above inclusion criteria, or
- Self-report uncontrolled diabetes (i.e., diagnosed with diabetes, and it is not being managed by a physician), or
- Present to the enrollment visit with a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 105 mm Hg, or
- Self-report involvement in another clinical trial, or
- Self-report hospitalization for psychiatric issues or had a heart-related event (e.g. heart attack) at enrollment or within the past 30 days, or
- Self-report attempts to quit or cut down on smoking in past 30 days, or
- Self-report use of pharmacotherapy to aid smoking cessation within the past 30 days, or
- Are breastfeeding, pregnant, or may become pregnant during the next six months, or
- Are planning to move out of San Diego in the next 9 weeks, or
- Do not meet expected expired carbon monoxide (CO) measurements of smokers (Expired CO measurements\>10 parts per million (ppm) will confirm status as a current smoker of at \>5 cigarettes/day on the initial visit), or
- Are deemed mentally unstable (i.e., psychotic, under influence of drugs or alcohol, or unable to comprehend the call or meeting) or physically unfit (i.e, physically unwell) to participate in the study based on the researcher's determination at the enrollment visit
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03749876
Start Date
January 17 2019
End Date
June 30 2020
Last Update
October 22 2020
Active Locations (1)
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1
California State University San Marcos
San Marcos, California, United States, 92096