Evidence map›Paper›PMID 34731268›Full record

Trial reportPsychopharmacology2022

An inpatient human laboratory study assessing the safety and tolerability, pharmacokinetics, and biobehavioral effect of GET 73 when co-administered with alcohol in individuals with alcohol use disorder.

Carolina L Haass-Koffler, Roberta Perciballi, Molly Magill, Antonella Loche, Roberto Cacciaglia, Lorenzo Leggio, Robert M Swift

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.4field-weighted citation impact, top 19% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. 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

7 authors at 2 institutions in 1 country.

Carolina L Haass-KofflerCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI, 02903, USA. carolina_haass-koffler@brown.edu.
Roberta PerciballiCenter for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.
Molly MagillCenter for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.
Antonella LocheLaboratorio CT, San Remo, Italy.
Roberto CacciagliaLaboratorio CT, San Remo, Italy.
Lorenzo LeggioCenter for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA.
Robert M SwiftCenter for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, 121 South Main Street, Providence, RI, 02903, USA.
Brown University · USGeorgetown University · US

Funding

Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Using wearables and EMA to examine the links between cannabis and depressionP20GM130414 · NIGMS · BROWN UNIVERSITY · PI Tyler Blake Wray · 2019 to 2026
$22.0M
Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIADA000635 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI LEGGIO, LORENZO · 2020 to 2025
$15.2M
ALCOHOL INTERVENTION/TREATMENT OUTCOME RESEARCH TRAININGT32AA007459 · NIAAA · BROWN UNIVERSITY · PI ROBERT MIRANDA, PETER M. MONTI · 1986 to 2026
$13.3M
A focus on alpha-1 blockade as a novel pharmacological treatment for alcohol use disorderR01AA027760 · NIAAA · BROWN UNIVERSITY · PI HAASS-KOFFLER, CAROLINA LUISA · 2019 to 2023
$2.6M
Lead optimization of novel CRFBP-CRFR2 complex modulators for alcohol use disorderR01AA026589 · NIAAA · SANFORD BURNHAM PREBYS MEDICAL DISCOVERY INSTITUTE · PI SHEFFLER, DOUGLAS J · 2019 to 2021
$2.4M
Mifepristone As A Pharmacological Intervention For Stress-Induced Alcohol DrinkingK01AA023867 · NIAAA · BROWN UNIVERSITY · PI HAASS-KOFFLER, CAROLINA LUISA · 2016 to 2020
$901k
Probenecid as pharmacotherapy for alcohol use disorderR21AA027614 · NIAAA · BROWN UNIVERSITY · PI HAASS-KOFFLER, CAROLINA LUISA · 2020 to 2021
$427k
Division of Intramural Research, National Institute of Drug Abuse ZIA-DA000635Intramural NIH HHS ZIA AA000218Intramural NIH HHS ZIA DA000635NIAAA NIH HHS K01 AA023867NIAAA NIH HHS R01 AA026589NIAAA NIH HHS R01 AA027760NIAAA NIH HHS R21 AA027614NIAAA NIH HHS T32 AA007459NIGMS NIH HHS P20 GM130414
6 · The paper itself

Abstract

rationalePrevious work suggests that GET 73, a novel compound with putative activity on the metabotropic glutamate receptor subtype 5 (mGluR5), may represent a novel pharmacological treatment for alcohol use disorder (AUD).

objectiveIn this study, we investigated the safety, tolerability, pharmacokinetics, and biobehavioral effects of GET 73, when co-administered with alcohol, in individuals with alcohol dependence (AD).

methodsThis was an inpatient, cross-over, randomized, double-blind, placebo-controlled, human laboratory study with non-treatment-seeking, alcohol-dependent individuals. The study used a within-subject design, with two counterbalanced stages, during which participants received GET 73 and then placebo, or vice versa. During each stage, participants underwent an alcohol interaction session and, on a separate day, an alcohol cue reactivity, followed by an alcohol self-administration session.

resultsSafety outcomes of GET 73 were excellent with no serious adverse events, nor adverse events of severe grade. The co-administration of alcohol and GET 73 did not affect the pharmacokinetics of GET 73 or alcohol. GET 73, compared to placebo, did not affect the alcohol-related stimulation effects, but increased the subjective sedative effects of alcohol. GET 73 did not affect alcohol cue-induced craving, or alcohol self-administration in the laboratory.

conclusionsThe study confirms the safety and tolerability of GET 73 when co-administered with alcohol. Although, under this experimental condition, we did not detect an effect on alcohol craving and consumption in the laboratory, additional studies should be conducted administering GET 73 for an extended period in an outpatient setting.

Indexed as

AlcoholismAlcohol DrinkingCravingDouble-Blind MethodHumansInpatientsLaboratoriesAlcohol dependence (AD)Alcohol use disorder (AUD)GET 73Metabotropic glutamate receptor subtype 5 (mGluR5)PharmacodynamicsPharmacokinetics

Identifiers

PMID34731268
PMCPMC8865311
OpenAlexW3208603886

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.