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Behavioral Pharmacology Associated With Cigar Smoking

NCT02218840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2023-02-28

No results posted yet for this study

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

Interventions

OTHER

Smoking topography

Evaluation of cigar smoking topography

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Michael R McGuire, MD · Lovelace Scientific Resources, Inc

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-01-08
Completion
2016-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218840 on ClinicalTrials.gov