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Bronchoscopy to Study E-Cigarette Effects in Cigarette Smokers
Study Summary
This trial is studying how smoking e-cigarettes affects the lungs by looking at changes in the DNA of lung cells.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had bronchitis or pneumonia in the past year.You have had general anesthesia within the past year.You smoke at least 5 cigarettes with filters per day for at least 1 year.You have been using inhaler medications regularly in the past 2 months.You have taken antibiotics in the last 30 days.You are allergic to propylene glycol, glycerin, or any flavors used in the study.You regularly smoke cigarettes that you make yourself.You have a medical condition that could make it risky to perform a bronchoscopy, affect the accuracy of biomarker data, or increase the chances of experiencing negative effects from using an e-cigarette.You have had a bad allergic reaction to varenicline in the past.You have used e-cigarettes or other tobacco products that you burn and inhale in the past 3 months.You had a bad reaction when using an e-cigarette before.Your weight is very high, which can make it difficult to manage your breathing during the study.You have been using marijuana regularly in the past three months.You have taken any kind of steroid medication, like corticosteroids, in the last 30 days.You are allergic to any of the study medications like lidocaine, Versed, fentanyl, or Cetacaine.You have immune system disorders that require medication.You have had issues with alcohol or drug abuse in the past three months.You are currently using nicotine replacement or other products to help you quit smoking, or you plan to quit smoking within the next three months.You have been diagnosed with kidney or liver disease in the past.You have a long-term lung condition like asthma, COPD, chronic bronchitis, or restrictive lung disease that requires regular use of medications.
- Group 1: Group IV (Nicotine Replacement Therapy [NRT])
- Group 2: Group I (usual cigarette brand)
- Group 3: Group II (SREC with nicotine)
- Group 4: Group III (SREC without nicotine)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still open enrollment opportunities for this research study?
"Affirmative. Clinicaltrials.gov reveals that this medical experiment, which was launched on September 17th 2018, is presently recruiting volunteers. A total of 239 participants are needed from one location."
How many participants have signed up to take part in this trial?
"Affirmative. According to records hosted on clinicaltrials.gov, this medical experiment was published on September 17th 2018 and is actively seeking participants with an updated post from August 4th 2022. The trial requires 239 volunteers across a single site for completion."
Does this research involve participants aged 35 or older?
"Patients aged between 21 and 45 are eligible to enroll in this clinical trial."
Have past research initiatives utilized Nicotine Replacement for their studies?
"Currently, 71 trials are underway to evaluate Nicotine Replacement Therapy. Five of these studies have entered their third phase and the majority of them can be found in Augusta, Georgia. However, 204 different medical sites around the world are conducting research into this intervention."
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