Smoking Clinical Trial
Official title:
Effect of Oral Black Raspberry Administration on Oral Cell DNA Adducts in Smokers
The purpose of this voluntary research study is to learn about the potential effects that black raspberry (BRB) lozenges may have on reducing the damage caused from cigarette smoke in mouth cells in adult smokers, which may be useful in reducing health risks associated with smoking.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 21-75 - Smoke 5 cigarettes per day or more for at least the past 12 months - Have an expired air carbon monoxide measurement of greater than 6 parts per million - No serious quit attempt in the last one month and not planning to quit in the next 4 months - Willing and able to attend all study visits - Able to read and write in English - Able to understand and provide consent to the study procedures - Willingness and ability to attend regular visits over a 14-week period and to respond to research contacts between the 5 Exclusion Criteria: - Unstable or significant medical conditions that affect participant safety or biomarker data in the past 3 months (e.g. recent heart attack, asthma or COPD) - Women currently pregnant or nursing - Use of any non-cigarette nicotine delivery product in the past 7 days (e.g. e-cigarettes, pipe or cigar) - Uncontrolled mental illness or inpatient treatment in the past 6 months; current suicide risk on clinical assessment - Any known allergy to raspberries - Use of marijuana or other illegal drugs daily or weekly in the past 3 months - Use of high dose antioxidant supplements in the past month - Use of antibiotics - Heavy drinking (>4 drinks/day, 5 days/week) - Made no serious cigarette smoking quit attempt or have used any FDA-approved smoking cessation medication in the prior 30 days - No plan to quit smoking within the next 4 months |
Country | Name | City | State |
---|---|---|---|
United States | Penn State CTSI Clinical Research Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of HPB-releasing adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks | Marker of DNA damage caused by tobacco specific nitrosamines in tobacco smoke | Baseline, end of 8-week BRB treatment | |
Secondary | Change of B[a]P adducts (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks | Marker of DNA damage caused by benzo[a]pyrene in tobacco smoke | Baseline, end of 8-week BRB treatment | |
Secondary | Change of 8-OXO-dG (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks | Biomarker of oxidative damage to DNA caused by tobacco smoke | Baseline, end of 8-week BRB treatment | |
Secondary | Change of Anthocyanin (buccal cells) from Baseline to end of BRB lozenge treatment at 8 weeks | Biomarker of exposure to the black raspberry chemopreventive anthocyanins | Baseline, end of 8-week BRB treatment | |
Secondary | Change of Cotinine (urine) from Baseline to end of BRB lozenge treatment at 8 weeks | Biomarker of tobacco smoke exposure | Baseline, end of 8-week BRB treatment | |
Secondary | Change of Creatinine (urine) from Baseline to end of BRB lozenge treatment at 8 weeks | Biomarker of urine dilution | Baseline, end of 8-week BRB treatment | |
Secondary | Change of 8-IsoP (urine) from Baseline to end of BRB lozenge treatment at 8 weeks | Biomarker of systemic oxidative stress | Baseline, end of 8-week BRB treatment |
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