Evidence map›Paper›PMID 24297304›Full record

ReviewPsychopharmacology2014

An efficient early phase 2 procedure to screen medications for efficacy in smoking cessation.

Kenneth A Perkins, Caryn Lerman

Open access · greenAbstract readReview
In one paragraph

Review in Psychopharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.8field-weighted citation impact, top 9% of its field
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

17 citing papers in PubMed, 32 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. The Nicotine Metabolite Ratio is Associated With Early Smoking Abstinence Even After Controlling for Factors That Influence the Nicotine Metabolite Ratio.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  5. Initial Evaluation of Fenofibrate for Efficacy in Aiding Smoking Abstinence.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
    Trial
  6. Does Extended Pre Quit Bupropion Aid in Extinguishing Smoking Behavior?Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2015
    Trial
  7. Trial
  8. The 2022 Ferno Award Address: CrEATE, an Efficient Crossover Evaluation of Addiction Treatment Efficacy.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2023
    Article
  9. Review
  10. Review
  11. Initial Cross-Over Test of A Positive Allosteric Modulator of Alpha-7 Nicotinic Receptors to Aid Cessation in Smokers With Or Without Schizophrenia.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2018
    Article
  12. Validating Use of Internet-Submitted Carbon Monoxide Values by Video to Determine Quit Status.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2017
    Article
  13. Withdrawal-Related Changes in Delay Discounting Predict Short-Term Smoking Abstinence.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2017
    Article
  14. Article
  15. Review
  16. Review
  17. 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

2 authors at 2 institutions in 1 country.

Kenneth A PerkinsWestern Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA, perkinska@upmc.edu.
Caryn Lerman
University of Pennsylvania · USUniversity of Pittsburgh · US

Funding

Neuroimaging Abstinence and Medication ResponseP50CA143187 · NCI · UNIVERSITY OF PENNSYLVANIA · PI AUDRAIN-MCGOVERN, JANET E · 2009 to 2013
$8.6M
NCI NIH HHS CA143187NCI NIH HHS P50 CA143187
6 · The paper itself

Abstract

rationaleInitial screening of new medications for potential efficacy (i.e., Food and Drug Administration (FDA) early phase 2), such as in aiding smoking cessation, should be efficient in identifying which drugs do, or do not, warrant more extensive (and expensive) clinical testing.

objectivesThis focused review outlines our research on development, evaluation, and validation of an efficient crossover procedure for sensitivity in detecting medication efficacy for smoking cessation. First-line FDA-approved medications of nicotine patch, varenicline, and bupropion were tested as model drugs, in three separate placebo-controlled studies. We also tested specificity of our procedure in identifying a drug that lacks efficacy, using modafinil.

resultsThis crossover procedure showed sensitivity (increased days of abstinence) during week-long "practice" quit attempts with each of the active cessation medications (positive controls) versus placebo, but not with modafinil (negative control) versus placebo, as hypothesized. Sensitivity to medication efficacy signal was observed only in smokers high in intrinsic quit motivation (i.e., already preparing to quit soon) and not smokers low in intrinsic quit motivation, even if monetarily reinforced for abstinence (i.e., given extrinsic motivation).

conclusionsA crossover procedure requiring less time and fewer subjects than formal trials may provide an efficient strategy for a go/no-go decision whether to advance to subsequent phase 2 randomized clinical trials with a novel drug. Future research is needed to replicate our results and evaluate this procedure with novel compounds, identify factors that may limit its utility, and evaluate its applicability to testing efficacy of compounds for treating other forms of addiction.

Indexed as

Antidepressive Agents, Second-GenerationBenzazepinesBupropionClinical Trials, Phase II as TopicCross-Over StudiesDrug Evaluation, PreclinicalFeasibility StudiesHumansQuinoxalinesResearch DesignSmoking CessationValidation Studies as TopicVareniclineAntidepressive Agents, Second-GenerationBenzazepinesBupropionQuinoxalinesVarenicline

Identifiers

PMID24297304
PMCPMC3910509
OpenAlexW2070324921

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.