Clinical trials: Alcohol-induced Disorders
Alcohol Use Disorder
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD).
- Trial name
- NCT03983317
- Testing
- Empower Neuromodulation System
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Theranova, L.L.C.
Severe Acute Alcoholic Hepatitis
To Assess Safety/Efficacy of ELAD in Subjects w/ Severe Acute Alcoholic Hepatitis (sAAH) and Lille Score Failure
The purpose of this study is to determine if treatment with the ELAD System is safe and effective in subjects with severe acute alcoholic hepatitis and Lille score failures (Lille score >0.45).
- Trial name
- NCT01829347
- Testing
- ELAD, Standard of Care treatment
- Where
- 39 sites in United States, Germany and 2 more
- Volunteers
- 18 people
- Sponsor
- Vital Therapies, Inc.
Gingival Bleeding, Plaque Induced Gingival Disease
Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen With CPC+Zn, Flossing and Brushing, and an Alcohol-based Mouthwash Regimen With Essential Oils in Reducing Plaque and Gingivitis.
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and to rising with an essential…
- Conditions
- Gingival Bleeding, Plaque Induced Gingival Disease, Gingival Diseases, Gingivitis and Periodontal Diseases
- Trial name
- PGMWII (NCT06598072)
- Testing
- Mouthwash CPC+Zn+F, Essential oils mouthwash, Dental floss
- Where
- Mexico
- Volunteers
- 120 people
- Sponsor
- Colgate Palmolive
Alcohol Use Disorder
PT150 Drug for Use in Alcohol Use Disorder
The goal of this study is to learn if PT150 can reduce the behavioral and physical effects of stress, alcohol, and alcohol use in people with alcohol use disorder.
- Trial name
- NCT06712602
- Testing
- alcohol, Stress-Induction, PT150
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Pop Test Oncology LLC
Liver Diseases, Alcoholic
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
- Trial name
- ALLSTAR (NCT07791043)
- Testing
- Efimosfermin alfa
- Where
- 4 sites in United States, Argentina
- Volunteers
- 274 people
- Sponsor
- GlaxoSmithKline
Alcoholism
ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed.
- Trial name
- NCT01218958
- Testing
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
- Volunteers
- 624 people
- Sponsor
- Alkermes, Inc.
Alcohol Use Disorder
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD). For any individual participant, the maximum duration of study participation is approximately 36 weeks, including…
- Trial name
- NCT06817356
- Testing
- Mazdutide
- Where
- 25 sites in United States
- Volunteers
- 308 people
- Sponsor
- Eli Lilly and Company
Alcohol Use Disorder
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with…
- Trial name
- NCT05913752
- Testing
- CMND-100
- Where
- 4 sites in United States, Israel
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Clearmind Medicine Inc.
Alcohol Use Disorder
Baclocur® Post-Authorisation Safety Study in Real-life Settings in France
The overall goal of the study is to further characterize the risks and the safety profile of Baclocur® in real life settings, over a 12-month follow-up period.
- Trial name
- BACLOLIFE (NCT04679142)
- Testing
- Baclofen Tablets
- Where
- France
- Volunteers
- 975 people
- Sponsor
- Ethypharm
Alcohol Abuse
Effectiveness and Safety of Probiotics in Protecting Liver Function
To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers
- Trial name
- NCT06607562
- Testing
- Probiotic group
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wecare Probiotics Co., Ltd.
Alcohol Use Disorder
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD).
- Trial name
- NCT05646303
- Testing
- Psilocybin
- Where
- 12 sites in Canada, Finland
- Volunteers
- 128 people
- Sponsor
- Clairvoyant Therapeutics
Alcohol Use Disorder (AUD)
RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight.
- Trial name
- NCT06987513
- Testing
- Pemvidutide
- Where
- 12 sites in United States
- Volunteers
- 100 people
- Sponsor
- Altimmune, Inc.
Severe Alcoholic Hepatitis
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus…
- Trial name
- NCT03087968
- Testing
- GS-4997, Prednisolone, HepQuant SHUNT Test
- Where
- 13 sites in United States
- Sponsor
- HepQuant, LLC
Alcohol Dependence
ALK29-002: A Study of Baclofen Formulations in Healthy Adults
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of different baclofen formulations.
- Trial name
- NCT00802035
- Testing
- Baclofen IR, Baclofen ER
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Alcohol Dependence
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care
- Trial name
- NCT02195817
- Testing
- Selincro® 18 mg with continuous psychosocial support: Cohort A, Initial psychosocial support: Cohort B
- Where
- 48 sites in France, Germany and 2 more
- Volunteers
- 378 people
- Sponsor
- H. Lundbeck A/S
Acute Alcoholic Hepatitis
Assess Safety and Efficacy of ELAD (Extracorporeal Liver Assist System) in Subjects With Alcohol-Induced Liver Failure
The primary objective of the study is to evaluate safety and efficacy of ELAD® with respect to overall survival (OS) of subjects with a clinical diagnosis of alcohol-induced liver decompensation (AILD) up to at least Study Day…
- Trial name
- NCT01471028
- Testing
- ELAD treatment, Standard of care (Control)
- Where
- 45 sites in United States, Australia and 2 more
- Volunteers
- 203 people
- Sponsor
- Vital Therapies, Inc.
Substance Dependence
EtOH Interaction Study
This study will investigate the possible effects of alcohol in combination with GSK598809 on the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years of age.
- Trial name
- NCT00887367
- Testing
- GSK598809, Ethanol
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Liver Diseases, Alcoholic
A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
- Trial name
- STARLIGHT (NCT06613698)
- Testing
- GSK4532990
- Where
- 140 sites in United States, Argentina and 16 more
- Volunteers
- 393 people
- Sponsor
- GlaxoSmithKline
Alcoholic Liver Cirrhosis
Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).
- Trial name
- NCT02806011
- Where
- South Korea
- Volunteers
- 48 people
- Sponsor
- Pharmicell Co., Ltd.
Alcohol Use Disorder
An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
An open-label, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 combined with relapse prevention psychological support, to explore the potential effects on…
- Trial name
- NCT05674929
- Testing
- BPL-003
- Where
- 2 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- Beckley Psytech Limited