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Combination Therapy for Alcohol Use Disorder Phase 2 45 Kombinationstherapie

Noch nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07249554 untersucht Behandlung im Zusammenhang mit Alkoholkonsumstörung. Diese interventionsstudie der Phase 2 hat den Status noch nicht rekrutierend. Der Start ist für 1. Mai 2026 geplant, bis 45 Teilnehmer aufgenommen werden. Durchgeführt von Johns Hopkins University wird der Abschluss für 1. Juni 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 9. März 2026 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel

Preliminary Safety and Efficacy of Semaglutide and Naltrexone Combination Therapy for Alcohol Use Disorder

Erkrankungen
Alkoholkonsumstörung
Weitere Studien-IDs
  • IRB00531545
NCT-Nummer
NCT07249554
Studienbeginn (tatsächlich)
2026-05
Zuletzt aktualisiert
2026-03-09
Studienende (vorauss.)
2028-06
Geplante Rekrutierung
45
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Noch nicht rekrutierend
Stichwörter
Glucagon-like peptide 1
Naltrexone
Alcohol Use Disorder
Addiction
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Placebo-VergleichspräparatPlacebo+Placebo
Placebo+Placebo
PLACEBO
Over-encapsulated non-active microcrystalline cellulose
ExperimentellPlacebo+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
ExperimentellGLP-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)
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Participant-reported Adverse Events
Participant-reported adverse events during the course of the trial
14 days
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
21 Years
Zugelassene Geschlechter
Alle
  • 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.
Johns Hopkins University logoJohns Hopkins University569 aktive klinische Studien zum Erkunden
Zentrale Studienkontakte
Kontakt: Andrew S Huhn, Ph.D., 410-550-1971, [email protected]
Kontakt: Breanna Labos, B.A., [email protected]
1 Studienstandorte in 1 Ländern

Maryland

Ashley Addiction Treatment, Havre de Grace, Maryland, 21078, United States
Andrew S Huhn, Ph.D., Kontakt, 410-550-1971, [email protected]