Evidence map›Paper›PMID 31082665›Full record

Trial reportDrug and alcohol dependence2019

Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV.

Rebecca L Ashare, Morgan Thompson, Katrina Serrano, Frank Leone, David Metzger, Ian Frank, Robert Gross, Anita Hole, Karam Mounzer, Ronald G Collman and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Drug and alcohol dependence, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01710137 (A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS), which is not on this map. Cited by 37 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 6 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT01710137 phase3completednot on this map

A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS

TypeinterventionalSponsorUniversity of PennsylvaniaRan2012 to 2018Enrolled179ConditionsNicotine DependenceArmsVarenicline, Placebo, Smoking Cessation Counseling
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 6 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Interventions for tobacco use cessation in people living with HIV.The Cochrane database of systematic reviews · 2024
    Pooled it
  4. Pooled it
  5. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  6. Pooled it
  7. Pilot Trial of a Behavioral Economics-Informed Clinical Decision Support Alert to Improve Inpatient Tobacco Use Treatment Rates.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. The role of alternative reinforcers in smoking outcomes among people with and without HIV.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2025
    Observational
  15. Differences in Cognition and Smoking Abstinence Rates Among People With and Without HIV Who Smoke.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2025
    Observational
  16. Article
  17. Article
  18. Article
  19. Article
  20. COPD in People with HIV: Epidemiology, Pathogenesis, Management, and Prevention Strategies.International journal of chronic obstructive pulmonary disease · 2023
    Review
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

12 authors at 3 institutions in 1 country.

Rebecca L AshareDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA. Electronic address: rlashare@pennmedicine.upenn.edu.
Morgan ThompsonDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.
Katrina SerranoDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.
Frank LeonePulmonary, Allergy, and Critical Care Division, University of Pennsylvania Presbyterian Medical Center, 51 N. 39th Street, Philadelphia, PA, USA.
David MetzgerDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.
Ian FrankDivision of Infectious Diseases, University of Pennsylvania, 3610 Hamilton Walk, Philadelphia, PA, USA.
Robert GrossDivision of Infectious Diseases, University of Pennsylvania, 3610 Hamilton Walk, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Anita HoleDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.
Karam MounzerPhiladelphia FIGHT, 1233 Locust Street, 3rd Floor, Philadelphia, PA, USA.
Ronald G CollmanPulmonary, Allergy and Critical Care Division, University of Pennsylvania, 522 Johnson Pavilion, 36th and Hamilton Walk, Philadelphia, PA, USA.
E Paul WileytoCenter for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.
Robert SchnollDepartment of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.
University of Pennsylvania · USPhiladelphia Fight · USUPMC Presbyterian · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI SHELLEY L BERGER · 1985 to 2026
$222.3M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Penn Mental Health AIDS Research CenterP30MH097488 · NIMH · UNIVERSITY OF PENNSYLVANIA · PI Knashawn Hodge Morales · 2013 to 2026
$23.5M
A Placebo Controlled Trial of Varenicline for Smoking among those with HIV/AIDSR01DA033681 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI SCHNOLL, ROBERT ADAM · 2012 to 2016
$2.5M
A Patient-Oriented Research Mentoring Program in Tobacco Dependence ResearchK24DA045244 · NIDA · UNIVERSITY OF PENNSYLVANIA · PI Robert Adam Schnoll · 2018 to 2026
$1.7M
NCI NIH HHS P30 CA016520NIAID NIH HHS P30 AI045008NIDA NIH HHS K24 DA045244NIDA NIH HHS R01 DA033681NIMH NIH HHS P30 MH097488
6 · The paper itself

Abstract

backgroundPeople living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH.

methodsThis was a single-site randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT01710137). PLWH on antiretroviral therapy (ART) who were treatment-seeking daily smokers were randomized (1:1) to 12 weeks of varenicline (n = 89) or placebo (n = 90). All participants were offered six smoking cessation behavioral counseling sessions. The primary outcome was 7-day point prevalence abstinence, confirmed with breath carbon monoxide, at Weeks 12 and 24. Continuous abstinence and time to relapse were secondary outcomes. Safety measures were treatment-related side effects, adverse events, blood pressure, viral load, and ART adherence.

resultsOf the 179 smokers, 81% were African American, and 68% were male. Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001). Continuous abstinence from Week 9 to 12 was higher for varenicline vs. placebo (23.6% vs. 10%; OR = 4.65, 95% CI:1.71-12.67, P = .003); at Week 24, there was no effect of varenicline for point prevalence (14.6% vs. 10%), continuous abstinence (10.1% vs. 6.7%), or time to relapse (Ps > .05). There were no differences between varenicline and placebo on safety measures (Ps > .05).

conclusionsVarenicline is safe and efficacious for short-term smoking cessation among PLWH and should be used to reduce tobacco-related life-years lost in this population.

Indexed as

SmokersAdultAgedDouble-Blind MethodFemaleHIV InfectionsHumansMaleMiddle AgedProspective StudiesSmoking CessationSmoking Cessation AgentsTobacco Use DisorderTreatment OutcomeVareniclineYoung AdultSmoking Cessation AgentsVareniclineAIDSHIVNicotine dependenceSmoking cessationTobacco useVarenicline

Identifiers

PMID31082665
PMCPMC6588414
OpenAlexW2944325048

What OpenQuestion holds

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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.