- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07249554
Thérapie combinée pour le trouble de l'utilisation de l'alcool
Sécurité et efficacité préliminaires de la thérapie combinée sémaglutide et naltrexone pour le trouble de l'usage d'alcool
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 when combined with other medications. Recently, emerging preclinical evidence suggests that endogenous GLP-1 signaling plays a role in alcohol-mediated behaviors. Further, growing clinical data suggest that GLP-1 agonists (e.g., Wegovy, Rybelsus, Mounjaro) may be effective for the treatment of AUD. Studies evaluating the efficacy of GLP-1 agonists in combination with FDA-approved medications for AUD have yet to be conducted. The investigators hypothesize that combining a GLP-1 agonist and naltrexone may be more effective for reducing dimensions of AUD than naltrexone alone. The goal of this study is to collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for AUD. Following one week of in-patient enrollment, participants will be randomized to one of three conditions in a double dummy design: placebo + placebo, GLP-1 + placebo, or GLP-1 + naltrexone. All study medications will be administered orally. Participants randomized to active GLP-1 conditions will receive 3 mg during study week 1 and can increase to 7 mg during week 2. Participants will attend study visits in a 14-day period to complete assessments of alcohol craving, alcohol demand, anhedonia, eating behaviors, and subjective effects. Participants will also provide vitals and biosamples to evaluate health outcomes.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Andrew S Huhn, Ph.D.
- Numéro de téléphone: 410-550-1971
- E-mail: ahuhn1@jhu.edu
Sauvegarde des contacts de l'étude
- Nom: Breanna Labos, B.A.
- E-mail: blabos1@jhmi.edu
Lieux d'étude
-
-
Maryland
-
Havre de Grace, Maryland, États-Unis, 21078
- Ashley Addiction Treatment
-
Contact:
- Andrew S Huhn, Ph.D.
- Numéro de téléphone: 410-550-1971
- E-mail: ahuhn1@jhu.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo+Placebo
Placebo+Placebo |
Over-encapsulated non-active microcrystalline cellulose |
|
Expérimental: Placebo+GLP-1
Placebo+GLP-1 |
Over-encapsulated non-active microcrystalline cellulose Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets |
|
Expérimental: GLP-1+Naltrexone
GLP-1+Naltrexone |
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets Over-encapsulated Naltrexone (oral tablets) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant-reported Adverse Events
Délai: 14 days
|
Participant-reported adverse events during the course of the trial |
14 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Andrew S. Huhn, Ph.D., Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Troubles liés à une substance
- Troubles induits chimiquement
- Troubles liés à l'alcool
- Comportement compulsif
- Comportement impulsif
- Comportement
- Alcoolisme
- Comportement, Addictif
- Composés hétérocycliques
- Composés hétérocycliques, anneau fusionné
- Alcaloïdes
- Hydrocarbures aromatiques polycycliques
- Composés polycycliques
- Composés hétérocycliques, 4 anneaux ou plus
- Naloxone
- Morphinans
- Alcaloïdes opiacés
- Composés hétérocycliques, anneau ponté
- Phénanthrène
- Naltrexone
Autres numéros d'identification d'étude
- IRB00531545
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Data may be shared upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
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