Combination Therapy for Alcohol Use Disorder

ConditionAlcohol Use Disorder

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age21-65

SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Placebo
Drug
Over-encapsulated non-active microcrystalline cellulose
Glucagon-Like Peptide-1 Agonist (GLP-1)
Drug
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
Naltrexone (oral tablets)
Drug
Over-encapsulated Naltrexone (oral tablets)

Treatment groups

45 Participants

are divided into 3 treatment groups

Group A: Placebo+PlaceboPlacebo comparator 1 intervention

Group B: Placebo+GLP-1Experimental treatment 2 interventions

Group C: GLP-1+NaltrexoneExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Participant-reported Adverse Events

Participant-reported adverse events during the course of the trial

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: