Clinical trials: Alcohol-Related Disorders
Alcohol Associated Hepatitis
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
- Trial name
- FRESH (NCT05639543)
- Testing
- INT-787
- Where
- 29 sites in United States, France and 1 more
- Volunteers
- 67 people
- Sponsor
- Intercept Pharmaceuticals
Substance Use Disorders, Opioid Use Disorder
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD)…
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder
- Trial name
- EDITOR (NCT06434818)
- Testing
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance), CBOT with olfactory stimulants & OFC tasks
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Evon Medics LLC
Alcohol Dependence
A Study in the Treatment of Alcohol Dependence.
H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management.
- Trial name
- NCT00805441
- Testing
- LY686017
- Where
- 21 sites in United States
- Volunteers
- 190 people
- Sponsor
- Eli Lilly and Company
Alcoholism
Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.
- Trial name
- OD-H (NCT00764660)
- Testing
- SCH 900435
- Volunteers
- 141 people
- Sponsor
- Merck Sharp & Dohme LLC
Alcohol Use Disorder
A Study of Brenipatide in Participants With Alcohol Use Disorder
The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use.
- Trial name
- RENEW-ALC-2 (NCT07219953)
- Testing
- LY3537031
- Where
- 116 sites in United States, Belgium and 6 more
- Volunteers
- 1,100 people
- Sponsor
- Eli Lilly and Company
Alcohol Dependence
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
- Trial name
- NCT02197598
- Testing
- nalmefene
- Where
- 3 sites in Germany
- Volunteers
- 45 people
- Sponsor
- H. Lundbeck A/S
Alcohol Use Disorder (AUD)
Sleep and Emotional Reactivity in Alcohol Use Disorder
Alcohol use disorder (AUD) is a multifaceted, chronic relapsing disorder suffered by millions of men and women in the United States.
- Trial name
- SEAS (NCT04979507)
- Testing
- Uninterrupted sleep followed by functional neuroimaging.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SRI International
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.
Substance Abuse, Criminal Behavior
Swift, Certain, and Fair: Reducing Recidivism and Improving Outcomes for Alcohol and Drug Users on State Parole
This research project will study the outcomes of medium- to high-risk parolees with a history of substance abuse in Alleghany County, Pennsylvania supervised under Swift-Certain-Fair parole.
- Trial name
- NCT03826420
- Testing
- SCF Supervision with Secure Confinement Sanctioning, SCF Supervision with Work Release Sanctioning, SCF Supervision with GPS Supervision Sanctioning
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Botec Analysis, LLC
Alcohol Dependence
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in…
- Trial name
- NCT01218971
- Testing
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
- Volunteers
- 332 people
- Sponsor
- Alkermes, Inc.
Alcoholism
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
- Trial name
- NCT00156923
- Testing
- Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
Alcohol Dependence
Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent
Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate whether GET 73, as compared to placebo, results in…
- Trial name
- SPAD (NCT01842503)
- Testing
- GET 73, inactive ingredients capsule
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Laboratorio Farmaceutico Ct S.r.l.
Alcohol Use Disorder (AUD)
Study of DCR-AUD in Healthy Volunteers
DCR-AUD will be evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers.
- Trial name
- NCT05021640
- Testing
- DCR-AUD
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Schizophrenia, Alcohol Use Disorder
A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use Disorder
This double-blind, randomized study will evaluate the efficacy, safety and tolerability of ALKS 3831 in subjects with schizophrenia and alcohol use disorder (AUD).
- Trial name
- NCT02161718
- Testing
- Samidorphan + olanzapine (ALKS 3831)
- Where
- 71 sites in United States, Bulgaria and 1 more
- Volunteers
- 300 people
- Sponsor
- Alkermes, Inc.
Alcoholism
An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence
The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.
- Trial name
- NCT00210925
- Testing
- topiramate
- Volunteers
- 371 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Addiction, Addiction, Alcohol
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in users with substance use disorder or problematic substance…
- Conditions
- Addiction, Addiction, Alcohol, Addiction, Substance
- Trial name
- NCT05434416
- Testing
- mobile app
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PredictWatch
Alcohol Use Disorder
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.
- Trial name
- NCT06545916
- Testing
- Sunobinop
- Where
- 7 sites in United States, Romania
- Volunteers
- 209 people
- Sponsor
- Knoa Pharma LLC
Prescription Drug Abuse, Substance Abuse
A High School Program for Preventing Prescription Drug Misuse
This project will develop and evaluate a program to prevent prescription drug misuse in high school students
- Conditions
- Prescription Drug Abuse, Substance Abuse, Substance Use (Drugs, Alcohol)
- Trial name
- NCT03219190
- Testing
- LST High School Hybrid
- Where
- United States
- Volunteers
- 1,804 people, healthy volunteers welcome
- Sponsor
- National Health Promotion Associates, 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
Alcohol Dependence
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.
- Trial name
- NCT00501631
- Testing
- VIVITROL 380 mg
- Volunteers
- 300 people
- Sponsor
- Alkermes, Inc.