Evidence map›Paper›PMID 36055978›Full record

Trial reportAlcoholism, clinical and experimental research2022

A randomized, double-blind, placebo-controlled, pharmacogenetic study of ondansetron for treating alcohol use disorder.

Chamindi Seneviratne, David A Gorelick, Kevin G Lynch, Clayton Brown, Danielle Romer, Timothy Pond, Kyle Kampman, Henry R Kranzler

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alcoholism, clinical and experimental research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Major Adverse Cardiac Events with Ondansetron: A Systematic Review.Clinical pharmacology and therapeutics · 2026
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
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 3 institutions in 1 country.

Chamindi SeneviratneDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-3135-2979
David A GorelickDepartment of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Kevin G LynchDepartment of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Clayton BrownDepartment of Epidemiology, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-0748-4509
Danielle RomerDepartment of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Timothy PondDepartment of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Kyle KampmanDepartment of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
Henry R KranzlerDepartment of Psychiatry, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-1018-0450
Philadelphia VA Medical Center · USUniversity of Maryland, Baltimore · USUniversity of Pennsylvania · US

Funding

1/2-Pharmacogenetic Treatments for AlcoholismR01AA021163 · NIAAA · UNIVERSITY OF VIRGINIA · PI GORELICK, DAVID ALAN, SENEVIRATNE, CHAMINDI · 2012 to 2017
$2.7M
2/2 Pharmacogenetic Treatment for AlcoholismR01AA021164 · NIAAA · UNIVERSITY OF PENNSYLVANIA · PI KRANZLER, HENRY RICHARD, PETTINATI, HELEN M · 2012 to 2016
$2.1M
NIAAA NIH HHS R01 AA021163NIAAA NIH HHS R01 AA021164
6 · The paper itself

Abstract

backgroundIn a previous study, ondansetron, a serotonin 5-HT

methodsIn this 16-week, double-blind, placebo-controlled, parallel-group clinical trial, adults with AUD were randomized to receive low-dose oral ondansetron (0.33 mg twice daily) or placebo stratified by "responsive" versus "nonresponsive" genotype defined using population-specific genotypes at the three genetic loci. Generalized estimating equation regression models and a modified intent-to-treat analysis were used to compare the treatment groups on the primary outcome-DPDD-and two secondary outcomes-heavy drinking days per week [HDD] and drinks per day [DPD] across the 16 weeks of treatment.

resultsOf 296 prospective participants screened, 95 (58 EA and 37 AA) were randomized and received at least one dose of study medication. In the modified intent-to-treat analysis, the ondansetron group averaged 0.40 more DPDD (p = 0.51), 1.35 times as many HDD (p = 0.16), and 1.06 times as many DPD (p = 0.59) as the placebo group. There were no significant interactions with genotype. There were no study-related serious adverse events (AEs) and similar proportions of participants in the two treatment groups experienced AEs across organ systems.

conclusionsWe found no evidence that low-dose oral ondansetron is beneficial in the treatment of AUD, irrespective of genotype, thus failing to confirm prior study findings. However, the study was underpowered to identify medication by genotype interactions.

Indexed as

AlcoholismOndansetronAdultDouble-Blind MethodHumansPharmacogenomic TestingProspective StudiesSerotoninSerotonin Plasma Membrane Transport ProteinsTreatment OutcomeOndansetronSerotoninSerotonin Plasma Membrane Transport ProteinsSLC6A4 protein, humanalcohol use disorderondansetronpharmacogeneticsrandomized control trialserotonin

Identifiers

PMID36055978
PMCPMC9901168
OpenAlexW4294542656

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.