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.
Alcohol dependence (AD)
Alcohol use disorder (AUD)
GET 73
Metabotropic glutamate receptor subtype 5 (mGluR5)
Pharmacodynamics
Pharmacokinetics
Journal
Psychopharmacology
ISSN: 1432-2072
Titre abrégé: Psychopharmacology (Berl)
Pays: Germany
ID NLM: 7608025
Informations de publication
Date de publication:
Jan 2022
Jan 2022
Historique:
received:
05
04
2021
accepted:
08
10
2021
pubmed:
4
11
2021
medline:
22
1
2022
entrez:
3
11
2021
Statut:
ppublish
Résumé
Previous 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). In 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). This 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. Safety 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. The 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.
Identifiants
pubmed: 34731268
doi: 10.1007/s00213-021-06008-1
pii: 10.1007/s00213-021-06008-1
pmc: PMC8865311
mid: NIHMS1780144
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
35-46Subventions
Organisme : NIAAA NIH HHS
ID : R01 AA027760
Pays : United States
Organisme : NIAAA NIH HHS
ID : R01 AA026589
Pays : United States
Organisme : Division of Intramural Research, National Institute of Drug Abuse
ID : ZIA-DA000635
Organisme : NIAAA NIH HHS
ID : K01 AA023867
Pays : United States
Organisme : NIGMS NIH HHS
ID : P20 GM130414
Pays : United States
Organisme : NIAAA NIH HHS
ID : R21 AA027614
Pays : United States
Organisme : Intramural NIH HHS
ID : ZIA AA000218
Pays : United States
Organisme : NIAAA NIH HHS
ID : T32 AA007459
Pays : United States
Organisme : Intramural NIH HHS
ID : ZIA DA000635
Pays : United States
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
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