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Lo studio clinico NCT07249554 per Disturbo da uso di alcol è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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Università Johns HopkinsCombination Therapy for Alcohol Use Disorder Fase II 45 Terapia combinata
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La sperimentazione clinica NCT07249554 è uno studio interventistico di Fase II volto a esaminare il trattamento per Disturbo da uso di alcol, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 maggio 2026, con l'obiettivo di raggiungere 45 partecipanti. Sotto la guida di l'Università Johns Hopkins, dovrebbe concludersi entro il 1 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 9 marzo 2026.
Sommario breve
This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.
Descrizione dettagliata
Approximately 29 million persons in the United States aged 12 and older experienced a form of Alcohol Use Disorder (AUD) in 2023. Currently, only three pharmacotherapies are FDA-approved to treat AUD: acamprosate, naltrexone, and disulfiram. As monotherapies, these have shown moderate efficacy in reducing alcohol consumption and increasing abstinence. There is some evidence that therapeutic effects can be enhanced wh...Mostra di più
Titolo ufficiale
Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder
Patologie
Disturbo da uso di alcolAltri ID dello studio
- IRB00531545
Numero NCT
Data di inizio (effettiva)
2026-05
Ultimo aggiornamento pubblicato
2026-03-09
Data di completamento (stimata)
2028-06
Arruolamento (previsto)
45
Tipo di studio
Interventistico
FASE
Fase II
Stato
Non ancora in arruolamento
Parole chiave
Glucagon-like peptide 1
Naltrexone
Alcohol Use Disorder
Addiction
Naltrexone
Alcohol Use Disorder
Addiction
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore placeboPlacebo+Placebo Placebo+Placebo | PLACEBO Over-encapsulated non-active microcrystalline cellulose |
SperimentalePlacebo+GLP-1 Placebo+GLP-1 | PLACEBO Over-encapsulated non-active microcrystalline cellulose Glucagon-Like Peptide-1 Agonist (GLP-1) Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets |
SperimentaleGLP-1+Naltrexone GLP-1+Naltrexone | Glucagon-Like Peptide-1 Agonist (GLP-1) Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets Naltrexone (oral tablets) Over-encapsulated Naltrexone (oral tablets) |
Esito primario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Participant-reported Adverse Events | Participant-reported adverse events during the course of the trial | 14 days |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
21 Years
Sessi idonei
Tutti
- Aged 21-65 years old
- Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation.
- Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder
- Willing to comply with the study protocol
- Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization
- Currently pregnant, breastfeeding
- Unwilling to use contraceptives (e.g., condoms and/or hormonal birth control)
- Meet criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder
- History of pancreatitis
- History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone.
- Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy
- Levels of amylase, lipase, aspartate aminotransferase (AST), and/or alanine transferase (ALT) greater than 2x upper limit of normal
- Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide
- Diagnosis of cancer within past 5 years
- History of multiple endocrine neoplasia syndrome type 2 (MEN2)
- Currently taking any medications contraindicated with GLP-1 agonists and/or naltrexone.
- BMI <18.5
- Current elevated suicide risk as assessed by clinic staff or the Columbia Suicide Severity Rating Scale (C-SSRS)
- Any other medical or psychological condition that is judged by the investigators to impede ability to safely complete study requirements.
- Legal problems or living situation judged by the investigators as a factor that could interfere with study completion (e.g., impending jail time).
- Allergies to semaglutide and/or naltrexone
- Use of opioids within the past 10 days as indicated by self-report or a positive urine drug screen
- Prescribed or taking the following medications in the past four weeks:
- The following medications will be prohibited during study participation due to interactions with semaglutide: other GLP-1 agonists (e.g. Exenatide, liraglutide, dulaglutide), insulin, insulin-secreting medications (e.g. sulfonylureas, meglitinides), tirzepetide, dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g. sitagliptin, saxagliptin, linagliptin, alogliptin, evogliptin, and gemigliptin).
- The following medications will be prohibited during study participation due to interactions with naltrexone: bremelanotide, peripherally-acting mu-opioid receptor antagonists (e.g. methylnaltrexone, naldemedine), and opioid agonist medications.
Università Johns Hopkins569 studi clinici attivi da esplorareContatti principali dello studio
Contatto: Andrew S Huhn, Ph.D., 410-550-1971, [email protected]
Contatto: Breanna Labos, B.A., [email protected]
1 Centri dello studio in 1 paesi
Maryland
Ashley Addiction Treatment, Havre de Grace, Maryland, 21078, United States
Andrew S Huhn, Ph.D., Contatto, 410-550-1971, [email protected]