Clinical trials: Alcohol Disorders
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.
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.
Major Depressive Disorder
A Study of LY2216684 in Healthy Participants
This study will evaluate the pharmacodynamic and pharmacokinetic interaction of LY2216684 with alcohol in healthy participants. This study will run approximately for 34 days.
- Trial name
- NCT01380691
- Testing
- LY2216684, Alcoholic beverage
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Alcoholism, Opiate Dependence
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection.
- Trial name
- NCT00156936
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
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.
Alcohol Use Disorder
Phase 1b Study of DCR-AUD in Healthy Volunteers
The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers.
- Trial name
- NCT05845398
- Testing
- DCR-AUD
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Alcoholism
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as…
- Trial name
- NCT01218997
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- Volunteers
- 436 people
- Sponsor
- Alkermes, Inc.
Adolescent Drinking, Adolescent Problem Behavior
Mindfulness Mobile App to Reduce Adolescent Substance Use
Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal…
- Trial name
- Qlarity (NCT04027075)
- Testing
- Qlarity app users
- Where
- United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Alcohol Dependence
A Study for the Treatment of Alcohol Dependence
The Primary objective of this study is to test whether LY2196044 can reduce the number of heavy drinking days per month in people with alcohol dependence.
- Trial name
- NCT00804570
- Testing
- LY2196044
- Where
- 17 sites in United States
- Volunteers
- 375 people
- Sponsor
- Eli Lilly and Company
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Burnout, Student, Alcohol; Harmful Use
Summative Assessment of the BurntOut 3D Simulation With Medical Students
Burnout is a common problem for medical students and is associated with stress-related health problems and also potentially affects the quality of care delivered to their patients.
- Conditions
- Burnout, Student, Alcohol; Harmful Use, Quality of Life, Depression
- Trial name
- NCT04494633
- Testing
- Clinical Encounters Medical School 3D Simulation
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Clinical Tools, Inc.
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.
Hepatorenal Syndrome
A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.
- Trial name
- NCT01143246
- Testing
- Terlipressin
- Where
- 73 sites in United States, Canada
- Volunteers
- 196 people
- Sponsor
- Mallinckrodt
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.
Acute on Chronic Hepatic Failure, Acute Liver Failure
Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF
The study will evaluate the pharmacokinetics, pharmacodynamics, safety and preliminary efficacy of IDN-6556 in subjects with cirrhosis of the liver who are hospitalized for more than 24 hours due to acute deterioration of liver…
- Conditions
- Acute on Chronic Hepatic Failure, Acute Liver Failure, Liver Cirrhosis, Acute Alcoholic Hepatitis
- Trial name
- NCT01937130
- Testing
- IDN-6556
- Where
- 26 sites in United States, United Kingdom
- Volunteers
- 23 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Alcoholic Hepatitis (AH)
Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).
- Trial name
- NCT02854631
- Testing
- Selonsertib, Prednisolone
- Where
- 44 sites in United States, Austria and 5 more
- Volunteers
- 104 people
- Sponsor
- Gilead Sciences
Alcohol Dependence
ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults
This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further…
- Trial name
- NCT00511836
- Testing
- VIVITROL 380 mg
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Alkermes, Inc.
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
Alcoholism
Clinical Study of TripleA for Treatment of Alcohol Addiction in Outpatient Care
The primary objective is to investigate differences in the alcohol consumption pattern between alcohol addicts receiving conventional treatment and those who receive a combination of conventional treatment and TripleA.
- Trial name
- NCT03195894
- Testing
- TripleA
- Volunteers
- 115 people
- Sponsor
- Kontigo Care AB
Alcohol Use Disorder
Treatment Parameters for the Empower Neuromodulation System (ENS)
The subject will be administered a treatment at a treatment location and then be asked if he/she believes it is the active treatment, sham treatment, or does not know.
- Trial name
- AUD1 (NCT03807544)
- Testing
- TENS
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Theranova, L.L.C.