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NCT02218840 · ClinicalTrials.gov registry record

Behavioral Pharmacology Associated With Cigar Smoking

A clinical trial, sponsored by Food and Drug Administration (FDA).

Completed
Registry status
77
Enrollment target

NCT02218840: Completed study, sponsored by Food and Drug Administration (FDA).

NCT02218840 is a clinical trial that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02218840 has completed, sponsored by Food and Drug Administration (FDA).

COMPLETED
Registry status
77 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • OTHER Smoking topography

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2014-04
Est. Completion 2016-03-02
Food and Drug Administration (FDA)

23 total trials

What the finished NCT02218840 record still lists

NCT02218840 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Smoking topography is the first listed.

NCT02218840 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02218840 about?

NCT02218840 is a clinical study titled "Behavioral Pharmacology Associated With Cigar Smoking". 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 ...

What is the current status of trial NCT02218840?

This trial is currently completed. The enrollment target is 77 participants. The study started on 2014-04. Estimated completion is 2016-03-02.

What interventions are being tested in trial NCT02218840?

The interventions under investigation include: Smoking topography (OTHER).

Who is sponsoring clinical trial NCT02218840?

This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02218840, the US trial registry maintained by the National Library of Medicine. NCT02218840 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.