A Study of Unfiltered Cigarettes Among Committed Smokers

Completed · Not applicable

Conditions studied: Cigarette Smoking, Tobacco Smoking

In brief

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-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (determined at time of randomization), and a 3-week washout period, followed by post-washout baseline week, and a crossover to 2 weeks of smoking the opposite condition.

Key facts

Study ID

NCT03749876

Run by

San Diego State University

People needed

37

Starts

2019-01-17

Expected to finish

2020-06-30

Last updated by the study team

2020-10-22

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California State University San Marcos — San Marcos, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.