Evidence map›Paper›PMID 28401564›Full record

Trial reportAlcoholism, clinical and experimental research2017

A Double-Blind Randomized Placebo-Controlled Trial of Oral Naltrexone for Heavy-Drinking Smokers Seeking Smoking Cessation Treatment.

Christopher W Kahler, Patricia A Cioe, Golfo K Tzilos, Nichea S Spillane, Lorenzo Leggio, Susan E Ramsey, Richard A Brown, Stephanie S O'Malley

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 15% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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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

8 authors at 6 institutions in 1 country.

Christopher W KahlerDepartment of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.ORCID http://orcid.org/0000-0002-6248-4149
Patricia A CioeDepartment of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.
Golfo K TzilosDepartment of Family Medicine, University of Michigan, Ann Arbor, Michigan.
Nichea S SpillaneDepartment of Psychology, University of Rhode Island, South Kingston, Rhode Island.
Lorenzo LeggioDepartment of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island.ORCID http://orcid.org/0000-0001-7284-8754
Susan E RamseyDepartment of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University and Rhode Island Hospital, Providence, Rhode Island.
Richard A BrownUniversity of Texas at Austin, Austin, Texas.
Stephanie S O'MalleyDepartment of Psychiatry, Yale School of Medicine, New Haven, Connecticut.
Brown University · USNational Institute on Drug Abuse · USThe University of Texas at Austin · USUniversity of Michigan · USUniversity of Rhode Island · USYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation TreatmentR01AA017181 · NIAAA · BROWN UNIVERSITY · PI KAHLER, CHRISTOPHER W. · 2009 to 2013
$3.0M
NCATS NIH HHS UL1 TR001863NIAAA NIH HHS R01 AA017181
6 · The paper itself

Abstract

backgroundPost hoc analyses of 2 randomized controlled trials suggest naltrexone may reduce alcohol use and improve smoking cessation outcomes among heavy drinkers receiving smoking cessation treatment. However, no studies have been conducted specifically to examine naltrexone for this purpose or to test whether naltrexone has benefit when added to smoking cessation counseling that explicitly addresses heavy drinking.

methodsWe recruited heavy-drinking smokers from the community and randomized them to receive 10 weeks of either (i) 50 mg naltrexone (n = 75) or (ii) placebo (n = 75) daily. Participants received 6 weeks of transdermal nicotine patch and 6 sessions of counseling that addressed both heavy drinking and smoking. Participants were followed for 26 weeks after their target quit smoking date.

resultsAcross medication conditions, there were substantial reductions at follow-up in percent heavy drinking days (primary outcome) and average drinks per week (secondary outcome). However, participants receiving naltrexone did not differ significantly from those receiving placebo on percent heavy drinking days (effect size d = -0.04, 95% CI [-0.30, 0.22], p = 0.76) or average drinks per week (d = -0.09, 95% CI [-0.35, 0.18], p = 0.54) during follow-up. Naltrexone compared to placebo was not associated with a significant increase in smoking abstinence rates during follow-up, odds ratio = 0.93, 95% CI [0.46, 1.86], p = 0.83. The effect of naltrexone on these outcomes was not significantly moderated by current alcohol dependence or gender.

conclusionsResults indicate that heavy-drinking smokers, including those with current alcohol dependence, can make substantial reductions in drinking in the context of smoking cessation treatment. However, this study provided no evidence that naltrexone is efficacious for enhancing reductions in drinking or improving smoking cessation in this population. Limitations of this study included lower-than-desired sample size and modest adherence to study medication.

Indexed as

Administration, OralAdultAlcohol DrinkingDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNaltrexoneNarcotic AntagonistsPatient Acceptance of Health CareSmokingSmoking CessationTobacco Use Cessation DevicesTreatment OutcomeNaltrexoneNarcotic AntagonistsAlcohol DependenceHeavy DrinkingNaltrexoneSmoking Cessation

Identifiers

PMID28401564
PMCPMC5485847
OpenAlexW2606222962

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.