Behavioral Pharmacology Associated With Cigar Smoking

NCT02218840 | Completed DMC

• 1 other identifier: 14-021CTP
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigar Smoking

Keywords

cigar smoker; smoking; behavioral pharmacology; smoking topography

Outcome Measures

Primary Outcomes (1)

• Assess Beharioral/Self-Reported Aspects of Cigar Smoking

  Characterize and quantify dependence, withdrawal relief, cravings, puff topography

  4 weeks

Secondary Outcomes (1)

• Evaluate smoking exposure

  4 weeks

Study Arms (1)

Behavioral

Evaluation of cigar smoking topography

Other: Smoking topography

Interventions

Smoking topography OTHER

Evaluation of cigar smoking topography

Behavioral

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Food and Drug Administration (FDA): lead

Study Sites (1)

Lovelace Scientific Resources, Inc

Albuquerque, New Mexico, 87108, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine

MeSH Terms

Conditions

Cigar Smoking; Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Michael R McGuire, MD

  Lovelace Scientific Resources, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 18, 2014
• Study Start: April 1, 2014
• Primary Completion: January 8, 2016
• Study Completion: March 2, 2016
• Last Updated: February 28, 2023

Record last verified: 2014-08

Locations

US (1)