Clinical Trial 42566

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San Antonio, TX 78209


Study Summary:

ICON Early Phase Services is conducting a research study for healthy adults who smoke cigarettes and are age 21 to 60. This study is being done to test the usage of cigarettes, nicotine gum and two electronic nicotine delivery systems (ENDS). There is no study drug involved. 

Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study. 

Participants will complete:

  •  1 screening visit
  •  8 consecutive overnights

To determine if you fully qualify, it will be necessary to obtain blood samples after a 12- hour fast.  You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.



If you are able to answer “YES” to the following statements, you may qualify for this study.

 

  • I am a healthy adult, meaning no significant medical conditions

 

  • I am between 21 and 60 (inclusive) years old

 

  • I weigh at least 110 lbs.

 

  • I have not participated in another clinical trial within (≤) 30 days prior to the signing of informed consent.

 

  • I smoke cigarettes only and I agree to smoke the same brand throughout the study period. 

 

  • I am willing to abstain from tobacco/nicotine use for at least 12 hours prior to each test session. 

 

  • I have not recently used any ENDS or other tobacco/nicotine containing product

 

  • I have not recently used any medication, or substance, that aids in smoking cessation

 

  • I am not employed by a tobacco/nicotine company and I do not handle tobacco/nicotine containing products (e.g., manufacturing) as part of my job

 

  • I am not postponing a decision to quit using tobacco/nicotine containing products to participate in this study

 

  • If Female, I am not pregnant or breastfeeding and I do not intend to become pregnant while on study  

 

  • If Female and capable of becoming pregnant, I agree to use contraception from the signing of consent until the end of the study.  Acceptable methods of contraception include: 

 

  • Barrier methods such as condoms (male or female), diaphragm, sponges, cervical cap and spermicide
    • Non-hormonal IUD
    • Essure procedure
    • Mirena or Kyleena
    • Vasectomized partner
    • Heterosexual abstinence if this is the preferred and usual lifestyle
    • Other methods may be approved with PI discretion.

 

  • If age 35 or over, I am not currently using systemic, estrogen-containing contraception or hormone replacement therapy

 

  • If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (tubes tied, ovaries removed, uterus removed, tubes removed).  Please provide records if possible.      

 

  • If Male and I have a partner capable of becoming pregnant, I agree to use a condom

 

  • If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above 

 

  • I am able to communicate effectively in English with the study personnel

 

  • I do not have any uncontrolled disease or any other concurrent disease or medical condition

 

  • I have not recently been treated for asthma

 

  • I do not have a history of cancer except for skin cancer that has been successfully treated

 

  • I do not have a history of bleeding or clotting disorders

 

  • I have not recently used anticoagulants or aspirin

 

  • I have not recently donated blood or plasma

 

  • I do not drink more than 21 servings of alcoholic beverages per week

 

  • I am able to refrain from strenuous physical activity (e.g., above your typical activity level), which could cause muscle aches or injury, from Screening until completion of the study

 

  • I am able to consume standardized meals. 

 

It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures.  Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit.  

No guarantees can be made regarding group assignments for any particular study.  ICON will not assume any liability for lost time, travel or failure to qualify.

To determine if you fully qualify, it will be necessary to obtain blood and urine  samples after a 12-hour fast.  You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples. 

If you fast, you should refrain from eating or drinking anything (with the exception of water) for 12 hours before your appointment.  We will be testing for tobacco use, alcohol and drug abuse.  Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. 

Be sure to bring all of your medications with you to your screening appointment. 

Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit.  We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport.  You will be required to show this same photo ID at all study visits.

You will be filling out paperwork for the study.  Please arrive at least 30 minutes in advance of your screening appointment.  If you are late for your appointment you may not be seen or may need to reschedule. 

Be advised that you may need to provide medical records as part of the screening process for this study.  If possible, please bring your full medical records with you to your screening appointment.  If you cannot bring your records with you, you must provide them before you can admit to the study.  Note that full medical records include surgical reports. 


Qualified Participants May Receive:

Qualified participants may be compensated up to $3,500 for time and travel.


Study is Available At:

ICON Early Phase Services, LLC
8307 Gault Lane
San Antonio, TX 78209
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.