Prevention of Oral DNA Damage by Black Raspberries

Completed · Not applicable

Conditions studied: Oral Cancer, Smoking, DNA Damage, Oxidative Stress

In brief

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.

Key facts

Study ID

NCT04372914

Run by

Milton S. Hershey Medical Center

People needed

69

Starts

2021-10-07

Expected to finish

2024-12-06

Last updated by the study team

2026-02-20

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Penn State CTSI Clinical Research Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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