Evidence map›Paper›PMID 39453550›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2024

Assessment of Abuse Liability and Nicotine Pharmacokinetics of glo Heated Tobacco Products in a Randomized, Crossover Study.

Milly N Kanobe, Patrudu Makena, Kristen Prevette, Sarah A Baxter

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05114863 (An In-Clinic Confinement Study to Assess Elements of Abuse Liability for a Heated Tobacco Product), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT05114863 nacompletednot on this map

An In-Clinic Confinement Study to Assess Elements of Abuse Liability for a Heated Tobacco Product (20020064) With Four Non-Combusted Cigarette Variants (40007385 - 40007388)

TypeinterventionalSponsorRAI Services CompanyRan2021 to 2022Enrolled75ConditionsSmoking, Smoking Behaviors, Tobacco Use, Tobacco SmokingArmsProduct A1, Product B, Product C, Product D, Product A2
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
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

4 authors.

Milly N KanobeRAI Services Company, 401 N. Main Street, Winston-Salem, NC, 27101, USA. kanobem@rjrt.com.ORCID http://orcid.org/0009-0006-2259-5481
Patrudu MakenaRAI Services Company, 401 N. Main Street, Winston-Salem, NC, 27101, USA.ORCID http://orcid.org/0000-0001-7199-0628
Kristen PrevetteRAI Services Company, 401 N. Main Street, Winston-Salem, NC, 27101, USA.ORCID http://orcid.org/0009-0000-1457-3561
Sarah A BaxterRAI Services Company, 401 N. Main Street, Winston-Salem, NC, 27101, USA.ORCID http://orcid.org/0000-0001-9473-9719

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveHeated tobacco products (HTPs) are a class of non-combustible, inhaled tobacco products with the potential to reduce the harm associated with cigarette smoking due to reduced cigarette smoke toxicant exposure. Subjective and nicotine pharmacokinetics measures taken over the course of product use provide a framework for abuse liability (AL) assessment of tobacco and nicotine products as well as information on adoption potential for a new tobacco product, which are important aspects for premarket tobacco product authorization by the US Food and Drug Administration. This study aimed to assess the AL of glo HTPs, operated in either Standard or Boost Modes, compared with high- and low-AL comparators (subjects' usual brand cigarettes and nicotine gum, respectively).

methodsNicotine uptake and pharmacodynamics measures (including subjective and physiological measures) were assessed in a clinical study of 75 healthy adult non-menthol or menthol smokers using an open-label, randomized crossover study design. Comparisons were made between glo HTPs (Standard or Boost Modes) and each of usual brand (UB) cigarettes and nicotine gum to evaluate nicotine exposure and subjective effects measures.

resultsNicotine uptake, as reflected in the area under the curve (AUC) at 15 and 240 min after product use (AUC

conclusionglo HTPs demonstrated lower AL than combustible cigarettes while delivering sufficient nicotine to support product adoption among current smokers. This positions glo HTPs as a potential tool in tobacco harm reduction, offering a less harmful alternative to traditional cigarettes. TRIAL REGISTRY: Clinical trial ID NCT05114863.

Indexed as

Cross-Over StudiesNicotineTobacco ProductsAdolescentAdultArea Under CurveFemaleHot TemperatureHumansMaleMiddle AgedNicotine Chewing GumTobacco Use DisorderYoung AdultNicotineNicotine Chewing Gum

Identifiers

PMID39453550
PMCPMC11549183

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.