Status:
COMPLETED
Behavioral Pharmacology Associated With Cigar Smoking
Lead Sponsor:
Food and Drug Administration (FDA)
Conditions:
Cigar Smoking
Eligibility:
All Genders
18-99 years
Brief Summary
Lovelace Scientific Resources is conducting clinical research study for cigar smokers. This study will be evaluating the behaviors of cigar smokers and the short term effects of cigar smoking. A ciga...
Detailed Description
This study seeks to better understand dependence behaviors in small and large cigar smokers. All recruited cigar smokers will be self-defined as users on ≥ 1 day(s) per week for the past 6 months. The...
Eligibility Criteria
Inclusion
- Willing to voluntarily sign the IRB approved informed consent form (ICF)
- Willing to complete all the requirements of the study
- Male or Female, ≥ 18 years of age
- Female subjects must be either:
- Surgically sterile defined as having had a hysterectomy, bilateral oophorectomy, or tubal ligation, amenorrheic for at least two years prior to screening visit, or otherwise incapable of becoming pregnant Or Willing to practice an effective method of birth control if sexually active, taking hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel, or abstinence may be used as a method of birth control
- Must be either a primary cigar or a secondary cigar smoker. Must have a self-reported history of using cigars on ≥1 day per week for the past 6 months
- Primary cigar users must report no significant prior use of cigarettes (\< 100 cigarettes in lifetime and no use of cigarettes in the past 6 months)
- Secondary cigar users must self-report regular use of cigarettes in the past before making the switch to cigars, and must report no use of cigarettes in the past 6 months
- Must be able to self-report inhaling behavior as either inhaler or non-inhaler
- Must be able to identify primary type of cigars smoked as either small cigar (including cigarillos), large cigars, or premium cigars
- English-speaking volunteers who are not seeking treatment for smoking cessation at the time of the study
- Have an exhaled carbon monoxide (CO) level of \<10 ppm at visit 2
- Demonstrate no clinically significant contraindications for study participation, in the judgment of the Principal Investigator
Exclusion
- Women of Child Bearing Potential (WOCBP) with a positive urine human chorionic gonadotropin (Urine β- hCG) pregnancy test within 10 days prior to Visit 2
- Pregnant and/or nursing females
- Use of any other type tobacco product (except cigars), non-tobacco nicotine-containing product(s), smoking cessation medications, such as varenicline (Chantix®) and bupropion (Zyban®), or NRT (Nicotine Replacement Therapy) within 60 days of study enrollment
- Have any previous self-reported medical adverse reaction to nicotine or tobacco, (for example nausea, headache and chest pain)
- Subjects who self-report a clinically significant concomitant disease or illness at either screening or visit 2, including but not limited to depression, schizophrenia, uncontrolled respiratory or cardiovascular disease, which in the opinion of the Principal Investigator or designee would preclude safe and /or successful completion of this study
- Subject demonstrates an elevated liver function of ≥ 2 times the upper limit of normal at screening
- Subject demonstrates an elevated renal function of ≥ 2 times the upper limit of normal at screening
- Subject intends to stop smoking cigars in the next month
- Unwilling to abstain from cigar smoking and all tobacco and nicotine use for at least 24 hours prior to exposure, Visit 2
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2016
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT02218840
Start Date
April 1 2014
End Date
March 2 2016
Last Update
February 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, United States, 87108