AL 5481-0001

San Antonio - Texas

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. 


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.


Qualified participants may be compensated up to $1,150 for time and travel.


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- 


o Intrauterine device or system for at least 3 month before admit (check in),


o 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, 


o Double barrier like condom with spermicide or diaphragm with spermicide for at least 2 weeks prior to admit.


o Sexual abstinence, defined as refraining from intercourse, when this is in line with the preferred and usual lifestyle of the subject.


o 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.  



If you are able to answer “YES” to the above questions and would like to make an appointment online please click on the following link:


CLICK HERE to make an apppointment for AL 5481-0001

** You must bring a pack of your usual cigarettes to your screening appointment.


Study Dates - Note: All dates and times are tentative and may change.

Cohort 1

COVID 19 Testing Friday Nov. 6, 2020
   
ADMIT Friday Nov. 13, 2020
DISCHARGE Monday Nov. 16, 2020

 


Notice:
In order to schedule a screening appointment online, you will be required to enter your personal information (name, date of birth, etc.) into a secure, password protected database.  Your information will remain confidential and will not be accessible by any party that does not work directly for ICON Early Phase Services.  It may be necessary for the recruitment staff to contact you by phone in the event of a schedule change or if more information is needed.  You have the right to remove your information from the database at any time by logging in to the scheduling program and choosing “My Profile” and then selecting the “Terminate Account” button.   


PURSUANT TO SECTION 30.06, 
PENAL CODE (TRESPASS BY HOLDER OF A LICENSE TO CARRY A CONCEALED HANDGUN) 
A PERSON LICENSED UNDER SUBCHAPTER H, CHAPTER 411, GOVERNMENT CODE (CONCEALED HANDGUN LAW), MAY NOT ENTER THIS PROPERTY WITH A CONCEALED HANDGUN.

 

Reference
AL 5481-0001
Name
AL 5481-0001
Details
Healthy Adult Smokers
Gender
Male or Female
Payment amount
up to $1,150
Age
21 - 45