Evidence map›Paper›PMID 39012011›Full record

Trial reportNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco2024

Varenicline Over-The-Counter Trial on Efficacy and Safety.

Jennifer Pearson, Mitchell A Nides, Alana Cataldo, Marisol Martinez, Jackie Morales, Ryan Seltzer, Jonathan Kurka, Matthew Broussard, Scott J Leischow

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

9 authors.

Jennifer PearsonDepartment of Health Behavior, Policy, and Administration Sciences, University of Nevada-Reno, Reno, Nevada, USA.ORCID 0000-0002-1400-5932
Mitchell A NidesLA Clinical Trials LLC, Los Angeles, California, USA.
Alana CataldoCollege of Health Solutions, Arizona State University, Tempe, Arizona, USA.
Marisol MartinezLA Clinical Trials LLC, Los Angeles, California, USA.
Jackie MoralesLA Clinical Trials LLC, Los Angeles, California, USA.
Ryan SeltzerCollege of Health Solutions, Arizona State University, Tempe, Arizona, USA.
Jonathan KurkaCollege of Health Solutions, Arizona State University, Tempe, Arizona, USA.
Matthew BroussardCollege of Health Solutions, Arizona State University, Tempe, Arizona, USA.
Scott J LeischowCollege of Health Solutions, Arizona State University, Tempe, Arizona, USA.

Funding

Varenicline OTC Trial on Efficacy and SafetyR01DA044125 · NIDA · ARIZONA STATE UNIVERSITY-TEMPE CAMPUS · PI DANIULAITYTE, RAMINTA · 2017 to 2021
$2.6M
NIDA NIH HHS R01 DA044125Pfizer WI234549
6 · The paper itself

Abstract

introductionVarenicline helps people who smoke quit at rates 2-3 times greater than placebo. Currently, in the United States, varenicline is not available over the counter (OTC). AIMS AND

methodsIn this study, we assessed the safety and efficacy of 1 mg and 0.5 mg varenicline as an OTC medication for smoking cessation in comparison to placebo. This randomized, double-blind, placebo-controlled study was performed at two clinical sites in the United States of n = 313 people. The treatment period was 12 weeks. During the COVID pandemic, the protocol was modified to allow remote participation; verification of smoking status was via breath carbon monoxide levels for in-person visits and mailed urine cotinine kits for the remote participants.

resultsThere was no difference in biologically confirmed continuous abstinence by condition between weeks 8 and 12; however, the odds of biologically confirmed point prevalence abstinence were higher for those in the 1 mg b.i.d. condition than for those in the placebo condition at week 12 (OR 3.39; 95% CI 1.49, 7.71), and were higher for those assigned to the 1.0 mg b.i.d. condition than the 0.5 mg b.i.d. condition at week 12 (OR 2.37; 95% CI 1.11, 5.05). Adverse events were modest, and as expected (vivid dreams and nausea in the medication conditions).

conclusionsThe results are suggestive that varenicline is safe and effective as an OTC medication.

Indexed as

Nonprescription DrugsSmoking CessationSmoking Cessation AgentsVareniclineAdultCOVID-19Double-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeUnited StatesNonprescription DrugsSmoking Cessation AgentsVarenicline

Identifiers

PMID39012011
PMCPMC12476975

What OpenQuestion holds

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Registered trials

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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.