Evidence map›Paper›PMID 23262301›Full record

Trial reportPharmacology, biochemistry, and behavior2013

A human laboratory pilot study with baclofen in alcoholic individuals.

Lorenzo Leggio, William H Zywiak, John E McGeary, Steven Edwards, Samuel R Fricchione, Jessica R Shoaff, Giovanni Addolorato, Robert M Swift, George A Kenna

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pharmacology, biochemistry, and behavior, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 5 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT01076283 phase2completednot on this map

A Pilot Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

TypeinterventionalSponsorBrown UniversityRan2009 to 2010Enrolled14ConditionsAlcoholismArmsBaclofen, Cyproheptadine
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, 5 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Pooled it
  3. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Baclofen for alcohol use disorder.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Baclofen for alcohol withdrawal.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Trial
  7. Trial
  8. The neurobiological markers of acute alcohol's subjective effects in humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Review
  18. Baclofen in the treatment of alcohol use disorder: tailored doses matter.Alcohol and alcoholism (Oxford, Oxfordshire) · 2024
    Review
  19. Review
  20. GABACurrent topics in behavioral neurosciences · 2022
    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

9 authors at 3 institutions in 2 countries.

Lorenzo LeggioCenter for Alcohol and Addiction Studies, Brown University, Providence, RI, USA. lorenzo.leggio@nih.gov
William H Zywiak
John E McGeary
Steven Edwards
Samuel R Fricchione
Jessica R Shoaff
Giovanni Addolorato
Robert M Swift
George A Kenna
Brown University · USUniversità Cattolica del Sacro Cuore · ITVeterans 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
NIAAA NIH HHS R03 AA020169
6 · The paper itself

Abstract

Preclinical and clinical studies show that the GABA(B) receptor agonist baclofen may represent a pharmacotherapy for alcohol dependence (AD). However, the mechanisms by which baclofen affects drinking are not well characterized; thus this pilot study investigated possible baclofen's biobehavioral mechanisms. The design was a double-blind controlled randomized human laboratory pilot study. Fourteen non-treatment seeking alcohol-dependent heavy drinking subjects received either baclofen 10mg t.i.d. or an active placebo (cyproheptadine 2mg t.i.d., to control for sedation) for a 7-day period. At day 8, participants performed an alcohol cue-reactivity (CR) followed by an alcohol self-administration (ASA). Additionally, we explored possible moderators that might guide future larger studies, i.e. anxiety, family history and onset of alcoholism, and D4 dopamine receptor (DRD4) and 5-HTTLPR polymorphisms. The main results were a significant effect of baclofen for increasing stimulation (p=.001) and sedation (p<.01). Furthermore, when drinking during the ASA and the 2 days before was analyzed as a composite variable, there was a significant effect of baclofen to reduce alcohol consumption (p<.01). As for the exploratory analyses, baclofen's effects to increase alcohol sedation and to reduce alcohol consumption were limited to those individuals with DRD4 ≥7 repeats (DRD4L). Yet, baclofen's effects on alcohol consumption were also moderated by 5-HTTLPR LL genotype. In conclusion, baclofen's ability to reduce alcohol drinking may be related to its effects on the biphasic effects of alcohol, but larger studies are needed to confirm these preliminary findings.

Indexed as

AlcoholicsAdultAlcohol DrinkingAlcoholismBaclofenDouble-Blind MethodFemaleFollow-Up StudiesGABA-B Receptor AgonistsHumansMaleMiddle AgedPilot ProjectsBaclofenGABA-B Receptor Agonists

Identifiers

PMID23262301
PMCPMC4287272
OpenAlexW2031918347

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.