Evidence map›Paper›PMID 20716302›Full record

Trial reportThe American journal on addictions

The safety and efficacy of varenicline in cocaine using smokers maintained on methadone: a pilot study.

James Poling, Bruce Rounsaville, Kishorchandra Gonsai, Kevin Severino, Mehmet Sofuoglu

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The American journal on addictions. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00567320 (Efficacy of Varenicline in Methadone-Stabilized Cocaine Users), which is not on this map. Cited by 40 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 12 pooled it
3.2field-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.

NCT00567320 nacompletednot on this map

Efficacy of Varenicline in Methadone-Stabilized Cocaine Users

TypeinterventionalSponsorYale UniversityRan2007 to 2009Enrolled31ConditionsCocaine Dependence, Nicotine DependenceArmsVarenicline, Sugar pill or Placebo
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 12 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Pooled it
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  3. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
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  8. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
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  9. Sex Differences in Varenicline Efficacy for Smoking Cessation: A Meta-Analysis.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2016
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  14. Sex-Specific Mediation of Pre-Quit Smoking Reduction: Secondary Analysis of a Randomized Controlled Trial Extending Varenicline Preloading.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
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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

5 authors at 2 institutions in 1 country.

James PolingYale University School of Medicine, VA Connecticut Healthcare System, West Haven, Connecticut 06516, USA. james.poling@yale.edu
Bruce Rounsaville
Kishorchandra Gonsai
Kevin Severino
Mehmet Sofuoglu
Yale University · USVA Connecticut Healthcare System · US

Funding

Pharmacotherapy & CM for Opioid and Cocaine DependenceR01DA021264 · NIDA · YALE UNIVERSITY · PI SOFUOGLU, MEHMET · 2007 to 2012
$2.1M
Progestrone and the Effects of NicotineR01DA014537 · NIDA · YALE UNIVERSITY · PI SOFUOGLU, MEHMET · 2003 to 2006
$855k
NIDA NIH HHS R01 DA014537NIDA NIH HHS R01DA014537NIDA NIH HHS R01 DA021264
6 · The paper itself

Abstract

In this double-blind, placebo-controlled trial, we compared varenicline (2 mg) to placebo for treatment for cocaine and tobacco dependence in 31 methadone-maintained subjects. Subjects received weekly counseling during the 12-week study participation. Our results indicate that varenicline is safe to give to this subject population, as there were no adverse events related to medication during this study. Varenicline was no more effective than placebo for abstinence from cocaine. Treatment with varenicline was associated with a reduced number of cigarettes smoked per day, even though subjects received only a brief education for smoking cessation. The self-report reduction in smoking was corroborated by CO levels and the Fagerström Test of Nicotine Dependence. However, self-ratings of positive mood on the Positive Affect Negative Affect Schedule did significantly decrease in the varenicline group as compared to the placebo group, although this appears to be due to randomization differences related to lifetime depression diagnosis. These preliminary findings may point to potential therapeutic value of varenicline for smoking cessation in cocaine users maintained on methadone.

Indexed as

BenzazepinesCocaine-Related DisordersDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMethadoneNicotinic AgonistsOpioid-Related DisordersPilot ProjectsQuinoxalinesSmoking CessationTobacco Use DisorderVareniclineBenzazepinesMethadoneNicotinic AgonistsQuinoxalinesVarenicline

Identifiers

PMID20716302
PMCPMC2966972
OpenAlexW1856850049

What OpenQuestion holds

Textmetadata
LicenceTDM
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.