Evidence map›Paper›PMID 24973894›Full record

Trial reportPsychopharmacology2015

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.

Lorenzo Leggio, William H Zywiak, Steven M Edwards, Jennifer W Tidey, Robert M Swift, George A Kenna

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

Trial report in Psychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01751386 (A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 4 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.

NCT01751386 phase2completednot on this map

A Double-Blind, Placebo-Controlled, Randomized Human Laboratory Pilot Study of Baclofen in Anxious Alcoholics

TypeinterventionalSponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ran2012 to 2016Enrolled39ConditionsAlcoholism, Alcohol Dependence, Alcohol Drinking Related Problems, Alcohol DrinkingArmsBaclofen, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Baclofen in the treatment of alcohol use disorder: tailored doses matter.Alcohol and alcoholism (Oxford, Oxfordshire) · 2024
    Review
  10. Review
  11. Article
  12. Article
  13. Baclofen-induced Changes in the Resting Brain Modulate Smoking Cue Reactivity: A Double-blind Placebo-controlled Functional Magnetic Resonance Imaging Study in Cigarette Smokers.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2020
    Article
  14. Opioid Craving in Human Laboratory Settings: a Review of the Challenges and Limitations.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Lorenzo LeggioSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, 10 Center Drive (10CRC/15330) MSC 1108; Room 1-5429, Bethesda, MD, 20892-1108, USA, lorenzo.leggio@nih.gov.
William H Zywiak
Steven M Edwards
Jennifer W Tidey
Robert M Swift
George A Kenna
Brown University · USButler Hospital · USJohn Brown University · USUniversity of Nebraska–Lincoln · USVeterans Health Administration · US

Funding

Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Effect of Baclofen on Alcohol Cue-Elicited Urges to Drink and SmokeR03AA020169 · NIAAA · BROWN UNIVERSITY · PI KENNA, GEORGE A. · 2010 to 2011
$79k
Intramural NIH HHS Z99 AA999999NIAAA NIH HHS R03 AA020169NIAAA NIH HHS R03AA020169
6 · The paper itself

Abstract

rationaleThere is presently no approved single treatment for dual alcohol and nicotine dependencies.

objectiveThis pilot study investigated baclofen effects in alcoholic smokers.

methodsThis was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment.

resultsBaclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type.

conclusionsThis study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.

Indexed as

AdultAlcohol DrinkingAlcoholicsAlcoholismBaclofenDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedPilot ProjectsSmokingTreatment OutcomeBaclofen

Identifiers

PMID24973894
PMCPMC4278944
OpenAlexW2035839366

What OpenQuestion holds

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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.