Evidence map›Paper›PMID 30023460›Full record

ArticleContemporary clinical trials communications2018

Cigarette Management System: An operating procedures guide to obtaining and managing investigational tobacco products for regulatory science research.

Abid Kazi, Alyse Fazzi, Nicolle M Krebs, Aimee J Merchlinski, Brenda Kline, Susan Veldheer, John P Richie, Jonathan Foulds, Tonya Lane, Eric C Donny and 1 more

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers With Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2021
    Trial
  3. Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine.American journal of preventive medicine · 2019
    Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Abid KaziDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Alyse FazziDepartment of Pharmacy, Investigational Drug Service Pharmacy, Penn State Health, Hershey, PA, United States.
Nicolle M KrebsDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Aimee J MerchlinskiDepartment of Public Health Sciences, Research Application Development, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Brenda KlineDepartment of Public Health Sciences, Research Application Development, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Susan VeldheerDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.
John P RichieDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Jonathan FouldsDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.
Tonya LaneCenter for the Evaluation of Tobacco Products, University of Minnesota, Minneapolis, MN, United States.
Eric C DonnyDepartment of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC, United States.
Joshua E MuscatDepartment of Public Health Sciences, Tobacco Center of Regulatory Science, Pennsylvania State University College of Medicine, Hershey, PA, United States.

Funding

VERY LOW NICOTINE CIGARETTES IN SMOKERS WITH SCHIZOPHRENIAU54DA031659 · NIDA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI LE, CHAP T. · 2011 to 2022
$64.7M
6 · The paper itself

Abstract

Investigational tobacco products, specifically variable nicotine content research cigarettes (SPECTRUM), are available through the National Institute of Drug Abuse Drug Supply Program. Randomized controlled trials using research cigarettes are intended to support tobacco regulatory science research. The current paper provides an in-depth look into managing research cigarettes for two multi-site clinical trials and the design of a computer-based Cigarette Management System (CMS). The paper provides guidance intended for any investigator using similar products on the operating procedures under Good Clinical Practice standards and describes features of the CMS. The CMS and procedures described have been field tested for the past three years and have dispensed over 160,000 cigarette packs to participants. The CMS can accommodate a range of practical issues with real-world study implementation making it a robust application that is scalable to any study.

Identifiers

PMID30023460
PMCPMC6024157

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.