ICON Early Phase Services is conducting a research study for healthy adult smokers ages 21-45. The purpose of this study is to measure the effect of 2 tobacco products compared to cigarettes in adult smokers.
Clinical trial study for healthy adult smokers ages 21-45
Vital signs, ECGs, physical examinations, pregnancy and drug testing will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
• 1 screening visit
• 3 consecutive overnights
Length of study from admit to end of study is 3 days.
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8-hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. For more information, see below.
If you are able to answer “YES” to the following statements, you may qualify for this study.
• I am a healthy smoking male or female, meaning no significant medical conditions
• I am between 21 and 45 years old
• My BMI is between 18.0 and 40.0 kg/m2
• I have not participated in a clinical study within 30 days prior to the first administration of this study product and I am not currently participating in another study
• I am a regular non-menthol cigarette smoker
• If Female, I am postmenopausal or surgically sterile by hysterectomy, bilateral tubal ligation, Essure, bilateral salpingectomy or bilateral oophorectomy (documentation required)
• If Female and able to have children, I agree to use a highly effective method of contraception for the duration required by the study which include one of the following-
– Intrauterine device or system for at least 3 month before admit (check in),
– hormonal contraceptives (eg, oral, vaginal ring, transdermal patch, implant, injection) when used in combination with male condoms with spermicide, for at least 3 months before admit,
– Double barrier like condom with spermicide or diaphragm with spermicide for at least 2 weeks prior to admit.
– Sexual abstinence, defined as refraining from intercourse, when this is in line with the preferred and usual lifestyle of the subject.
– Documented sterile male partner
• I have suitable veins for multiple blood samples
• I am able to communicate effectively in English with the study personnel
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 an 8-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 8 hours before your appointment. We will be testing for drugs of abuse, tobacco and alcohol.
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.
Name of Clinical Site
8307 Gault Lane, San Antonio, TX, USA