Evidence map›Paper›PMID 27658483›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2017

A Phase 2, Double-Blind, Placebo-Controlled Randomized Trial Assessing the Efficacy of ABT-436, a Novel V1b Receptor Antagonist, for Alcohol Dependence.

Megan L Ryan, Daniel E Falk, Joanne B Fertig, Beatrice Rendenbach-Mueller, David A Katz, Katherine A Tracy, Eric C Strain, Kelly E Dunn, Kyle Kampman, Elizabeth Mahoney and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
15.0field-weighted citation impact, top 1% 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

47 citing papers in PubMed, 69 citations in OpenAlex.

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  16. Activation of hypothalamic oxytocin neurons reduces binge-like alcohol drinking through signaling at central oxytocin receptors.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021
    Article
  17. Article
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  19. Vasopressin V1B Receptor Antagonists as Potential Antidepressants.The international journal of neuropsychopharmacology · 2021
    Review
  20. Do behavioral pharmacology findings predict clinical trial outcomes? A proof-of-concept in medication development for alcohol use disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2021
    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

18 authors at 8 institutions in 1 country.

Megan L RyanDivision of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Daniel E FalkDivision of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Joanne B FertigDivision of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Beatrice Rendenbach-MuellerNeuroscience Development, AbbVie, North Chicago, IL, USA.
David A KatzNeuroscience Development, AbbVie, North Chicago, IL, USA.
Katherine A TracyNeuroscience Development, AbbVie, North Chicago, IL, USA.
Eric C StrainJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Kelly E DunnJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Kyle KampmanUniversity of Pennsylvania, Treatment Research Center, Philadelphia, PA, USA.
Elizabeth MahoneyUniversity of Pennsylvania, Treatment Research Center, Philadelphia, PA, USA.
Domenic A CirauloBoston University School of Medicine, Boston, MA, USA.
Laurie Sickles-ColaneriBoston University School of Medicine, Boston, MA, USA.
Nassima Ait-DaoudDepartment of Psychiatric Medicine, University of Virginia, Charlottesville, VA, USA.
Bankole A JohnsonDepartment of Psychiatric Medicine, University of Virginia, Charlottesville, VA, USA.
Janet RansomFast Track Drugs and Biologics, North Potomac, MD, USA.
Charles ScottFast Track Drugs and Biologics, North Potomac, MD, USA.
George F KoobDivision of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Raye Z LittenDivision of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
National Institute on Alcohol Abuse and Alcoholism · USAbbVie (United States) · USBoston University · USFast Track Drugs and Biologics · USJohns Hopkins University · USUniversity of Virginia · USTreatment Research Institute · USUniversity of Pennsylvania · US

Funding

Neurobiology of AddictionZICDA000602 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI KOOB, GEORGE · 2015 to 2018
$5.4M
6 · The paper itself

Abstract

Alcohol use disorder has been linked to dysregulation of the brain stress systems, producing a negative emotional state leading to chronic relapsing behavior. Vasopressin receptors appear to have a regulatory role in stress, anxiety, and alcohol. This study evaluated the novel compound, ABT-436, a V1b receptor antagonist, in alcohol-dependent participants in a 12-week clinical trial. Men and women (n=150) who met criteria for DSM-IV alcohol dependence were recruited across four sites. Participants received double-blind ABT-436 or placebo, and a computerized behavioral intervention. ABT-436 was titrated to 800 mg/day during weeks 2-12. Although the primary outcome, percentage of heavy drinking days, was lower in participants receiving ABT-436 compared with placebo, this difference was not statistically significant (31.3 vs 37.6, respectively; p=0.172; d=0.20). However, participants receiving ABT-436 had significantly greater percentage of days abstinent than those receiving placebo (51.2 vs 41.6, respectively; p=0.037; d=0.31). No significant differences were found between treatment groups on any other measures of drinking, alcohol craving, or alcohol-related consequences. Smokers receiving ABT-436 smoked significantly fewer cigarettes per week than those receiving placebo (p=0.046). ABT-436 was well tolerated, with diarrhea (mild-to-moderate severity) being the most common side effect. In subgroup analyses, participants with relatively higher baseline levels of stress responded better to ABT-436 than placebo on select drinking outcomes, suggesting there may be value in testing medications targeting the vasopressin receptor in high stress, alcohol-dependent patients.

Indexed as

AdultAlcohol DrinkingAlcoholismAntidiuretic Hormone Receptor AntagonistsAnxietyDouble-Blind MethodFemaleHumansMaleMiddle AgedReceptors, VasopressinTreatment OutcomeAntidiuretic Hormone Receptor AntagonistsReceptors, Vasopressin

Identifiers

PMID27658483
PMCPMC5506792
OpenAlexW2521147165

What OpenQuestion holds

Textmetadata
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.