Naltrexone augmented with prazosin for alcohol use disorder: results from a randomized controlled proof-of-concept trial.
Alcohol Alcohol
; 59(5)2024 Jul 21.
Article
em En
| MEDLINE
| ID: mdl-39270736
ABSTRACT
AIMS:
We conducted a proof-of-concept randomized controlled trial of the mu-opioid receptor antagonist, naltrexone, augmented with the alpha-1 adrenergic receptor antagonist, prazosin, for alcohol use disorder in veterans. We sought a signal that the naltrexone plus prazosin combination regimen would be superior to naltrexone alone.METHODS:
Thirty-one actively drinking veterans with alcohol use disorder were randomized 1111 to naltrexone plus prazosin (NAL-PRAZ [n = 8]), naltrexone plus placebo (NAL-PLAC [n = 7]), prazosin plus placebo (PRAZ-PLAC [n = 7]), or placebo plus placebo (PLAC-PLAC [n = 9]) for 6 weeks. Prazosin was titrated over 2 weeks to a target dose of 4 mg QAM, 4 mg QPM, and 8 mg QHS. Naltrexone was administered at 50 mg QD. Primary outcomes were the Penn Alcohol Craving Scale (PACS), % drinking days (PDD), and % heavy drinking days (PHDD).RESULTS:
In the NAL-PRAZ condition, % reductions from baseline for all three primary outcome measures exceeded 50% and were at least twice as large as % reductions in the NAL-PLAC condition (PACS 57% vs. 26%; PDD 51% vs. 22%; PHDD 69% vs. 15%) and in the other two comparator conditions. Standardized effect sizes between NAL-PRAZ and NAL-PLAC for each primary outcome measure were >0.8. All but one participant assigned to the two prazosin containing conditions achieved the target prazosin dose of 16 mg/day and maintained that dose for the duration of the trial.CONCLUSION:
These results suggest that prazosin augmentation of naltrexone enhances naltrexone benefit for alcohol use disorder. These results strengthen rationale for an adequately powered definitive randomized controlled trial.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Prazosina
/
Alcoolismo
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Quimioterapia Combinada
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Antagonistas de Receptores Adrenérgicos alfa 1
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Estudo de Prova de Conceito
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Naltrexona
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Antagonistas de Entorpecentes
Limite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Alcohol Alcohol
Ano de publicação:
2024
Tipo de documento:
Article
País de publicação:
Reino Unido