Evidence map›Paper›PMID 22244707›Full record

Trial reportAddictive behaviors2012

Baclofen promotes alcohol abstinence in alcohol dependent cirrhotic patients with hepatitis C virus (HCV) infection.

L Leggio, A Ferrulli, A Zambon, F Caputo, G A Kenna, R M Swift, G Addolorato

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

Trial report in Addictive behaviors, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 39 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 4 pooled it
4.4field-weighted citation impact, top 6% 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

39 citing papers in PubMed, 4 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Efficacy of Psychosocial Interventions in Inducing and Maintaining Alcohol Abstinence in Patients With Chronic Liver Disease: A Systematic Review.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2016
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. A human laboratory pilot study with baclofen in alcoholic individuals.Pharmacology, biochemistry, and behavior · 2013
    Trial
  8. Integrated Multidisciplinary Management of Alcohol-associated Liver Disease.Journal of clinical and translational hepatology · 2023
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. An Overview of Pharmacotherapy Options for Alcohol Use Disorder.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2018
    Article
  17. Article
  18. Review
  19. Review
  20. Management of alcohol misuse in patients with liver diseases.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2017
    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

7 authors at 4 institutions in 2 countries.

L LeggioCenter for Alcohol and Addiction Studies, Brown University, Providence, RI 02912, USA. Lorenzo_Leggio@brown.edu
A Ferrulli
A Zambon
F Caputo
G A Kenna
R M Swift
G Addolorato
Università Cattolica del Sacro Cuore · ITBrown University · USOspedale SS. Annunziata · ITUniversity of Milano-Bicocca · IT

Funding

Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Effects of Ghrelin on Alcohol Cue Reactivity and CravingR21AA019709 · NIAAA · BROWN UNIVERSITY · PI KENNA, GEORGE A. · 2010 to 2011
$436k
Effect of Baclofen on Alcohol Cue-Elicited Urges to Drink and SmokeR03AA020169 · NIAAA · BROWN UNIVERSITY · PI KENNA, GEORGE A. · 2010 to 2011
$79k
NIAAA NIH HHS R03 AA020169NIAAA NIH HHS R21 AA019709
6 · The paper itself

Abstract

Hepatitis C virus (HCV) and alcoholic liver disease (ALD), either alone or in combination, count for more than two thirds of all liver diseases in the Western world. There is no safe level of drinking in HCV-infected patients and the most effective goal for these patients is total abstinence. Baclofen, a GABA(B) receptor agonist, represents a promising pharmacotherapy for alcohol dependence (AD). Previously, we performed a randomized clinical trial (RCT), which demonstrated the safety and efficacy of baclofen in patients affected by AD and cirrhosis. The goal of this post-hoc analysis was to explore baclofen's effect in a subgroup of alcohol-dependent HCV-infected cirrhotic patients. Any patient with HCV infection was selected for this analysis. Among the 84 subjects randomized in the main trial, 24 alcohol-dependent cirrhotic patients had a HCV infection; 12 received baclofen 10mg t.i.d. and 12 received placebo for 12-weeks. With respect to the placebo group (3/12, 25.0%), a significantly higher number of patients who achieved and maintained total alcohol abstinence was found in the baclofen group (10/12, 83.3%; p=0.0123). Furthermore, in the baclofen group, compared to placebo, there was a significantly higher increase in albumin values from baseline (p=0.0132) and a trend toward a significant reduction in INR levels from baseline (p=0.0716). In conclusion, baclofen was safe and significantly more effective than placebo in promoting alcohol abstinence, and improving some Liver Function Tests (LFTs) (i.e. albumin, INR) in alcohol-dependent HCV-infected cirrhotic patients. Baclofen may represent a clinically relevant alcohol pharmacotherapy for these patients.

Indexed as

AdolescentAdultAgedAlcohol DeterrentsAlcoholismBaclofenFemaleGABA-B Receptor AgonistsHepatitis C, ChronicHumansLiver Cirrhosis, AlcoholicMaleMiddle AgedTemperanceTreatment OutcomeYoung AdultAlcohol DeterrentsBaclofenGABA-B Receptor Agonists

Identifiers

PMID22244707
PMCPMC4975777
OpenAlexW2048597491

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.