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Behavioral Pharmacology Associated With Cigar Smoking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218840
Recruitment Status : Unknown
Verified August 2014 by Food and Drug Administration (FDA).
Recruitment status was:  Recruiting
First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Collaborators:
Lovelace Scientific Resources, Inc
Lovelace Biomedical and Environmental Research Institute
Information provided by (Responsible Party):
Food and Drug Administration (FDA)

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 cigar is defined as a cylinder of tobacco wrapped in a tobacco leaf for smoking. There are small cigars with filters that resemble cigarettes and large cigars that do not have filters. Because cigars come in so many shapes and sizes, the nicotine content varies as well. The way that a cigar smoker consumes the cigar can also have an effect on how much nicotine is absorbed. This study seeks to understand nicotine consumption and addiction in cigar smokers.

Study participation will last 1 to 4 weeks and will include 2 study-related visits. Your visits may include a physical exam, medical history review, questionnaires, blood collections, providing a urine sample, an exhaled breath test, having your vital signs collected and smoking a cigar. You will be videotaped while you smoke your cigar so that we can review the technique you use while smoking.

STUDY HYPOTHESES:

  • Significant reductions in craving and withdrawal will be reported after ad libitum smoking of a cigar compared to self-report prior to cigar smoking.
  • Cigar smokers will show a range of nicotine dependence, with a subset of users exceeding minimal criteria for nicotine dependence.
  • Levels of nicotine, cotinine, Carbon Monoxide (CO), and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) will increase significantly from pre- to post-cigar smoking.
  • Small cigar/cigarillo users will demonstrate greater levels of dependence and greater relief from craving and withdrawal compared to large cigar users.

Condition or disease Intervention/treatment
Cigar Smoking Other: Smoking topography

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Study Type : Observational
Estimated Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Behavioral Pharmacology Associated With Cigar Smoking
Study Start Date : April 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Group/Cohort Intervention/treatment
Behavioral
Evaluation of cigar smoking topography
Other: Smoking topography
Evaluation of cigar smoking topography




Primary Outcome Measures :
  1. Assess Beharioral/Self-Reported Aspects of Cigar Smoking [ Time Frame: 4 weeks ]
    Characterize and quantify dependence, withdrawal relief, cravings, puff topography


Secondary Outcome Measures :
  1. Evaluate smoking exposure [ Time Frame: 4 weeks ]
    Identifying smoking puff topography and laboratory markers of exposure (nicotine, NNAL, breath CO, and cotinine).


Biospecimen Retention:   Samples Without DNA
blood, urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects will be cigar smokers who are not seeking treatment for smoking cessation and who are not currently using any other type of tobacco, but may be former users.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218840


Contacts
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Contact: Michael R McGuire, MD 505.348.9500

Locations
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United States, New Mexico
Lovelace Scientific Resources, Inc Recruiting
Albuquerque, New Mexico, United States, 87108
Principal Investigator: Michael R McGuire, MD         
Sponsors and Collaborators
Food and Drug Administration (FDA)
Lovelace Scientific Resources, Inc
Lovelace Biomedical and Environmental Research Institute
Investigators
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Principal Investigator: Michael R McGuire, MD Lovelace Scientific Resources, Inc
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Responsible Party: Food and Drug Administration (FDA)
ClinicalTrials.gov Identifier: NCT02218840    
Other Study ID Numbers: 14-021CTP
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: August 18, 2014
Last Verified: August 2014
Keywords provided by Food and Drug Administration (FDA):
cigar smoker
smoking
behavioral pharmacology
smoking topography