Clinical trials: Alcohol-induced Disorders
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
Alcohol Drinking, Alcohol Use, Unspecified
Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
This is the first clinical trial of Endourage OMD 1200 for persons desiring to reduce their alcohol consumption.
- Conditions
- Alcohol Drinking, Alcohol Use, Unspecified, Alcohol Abstinence, Alcohol-Related Disorders
- Trial name
- NCT04659278
- Testing
- Endourage 1200 mg OMD ™ Oral Mucosal Drops, Isolate, Peppermint Oil, masking flavor
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Endourage, LLC
Alcohol Use Disorder, Post Traumatic Stress Disorder
CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
The primary objective of this study is to evaluate the feasibility of the revised brain training program with individuals diagnosed with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
- Trial name
- NCT03200028
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Posit Science Corporation
Marijuana Use, Marijuana Dependence
Examining Effects of Domain Specific Episodic Future Thinking on Cannabis Use
The overarching goal of this online study is to compare the efficacy of six (weekly) sessions of Domain-Specific Episodic Future Thinking (DS-EFT) relative an active control condition on improving the ability to value future…
- Conditions
- Marijuana Use, Marijuana Dependence, Tobacco Use, Alcohol Use, Unspecified
- Trial name
- NCT05324813
- Testing
- Domain-Specific Episodic Future Thinking
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Michael Sofis
Alcoholic Liver Cirrhosis
Long-Term Follow-up of Patients With Alcoholic Liver Cirrhosis Treated With Cellgram-LC
The goal of this observational study is to learn about the long-term safety of Cellgram-LC in patients with alcoholic liver cirrhosis who previously received Cellgram-LC in the PMC-P-07 study.
- Trial name
- NCT05093881
- Where
- 14 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- Pharmicell Co., Ltd.
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.
Acute Liver Failure
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of…
- Trial name
- NCT01452295
- Testing
- ELAD (Extracorporeal Liver Assist System)
- Sponsor
- Vital Therapies, Inc.
Alcohol Abuse, Drug Abuse
A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
The objective of this pilot study is to evaluate the feasibility and technical merit of a web application for patients in primary care called Check-up and Choices (CC).
- Trial name
- NCT01830114
- Testing
- Web app
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Behavior Therapy Associates, LLP
Alcohol Use Disorder, Alcohol Abuse
tAN for Substance Use Disorder
The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD).
- Conditions
- Alcohol Use Disorder, Alcohol Abuse, Substance Use Disorders, Substance Use Disorders Alcohol Use Withdrawal State
- Trial name
- NCT07281261
- Testing
- Sparrow Ascent
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Spark Biomedical, Inc.
Alcohol Use Disorder
Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms
Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief…
- Trial name
- ONWARD (NCT04101227)
- Testing
- AD04 (ondansetron), Companion Diagnostic for Genetic Testing, Brief Psychological Counseling
- Where
- 25 sites in Bulgaria, Croatia and 5 more
- Volunteers
- 302 people
- Sponsor
- Adial Pharmaceuticals
Alcohol Use Disorder
Acamprosate Initiated During Alcohol Detoxification
Acamprosate is approved by the Food and Drug Administration (FDA) for the treatment of alcoholism. The purpose of this study is to see if initiating acamprosate early in alcohol detoxification instead of waiting until…
- Trial name
- NCT00360594
- Testing
- Acamprosate
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Forest Laboratories
Alcohol Dependence
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.
- Trial name
- SENSE (NCT00811941)
- Testing
- Nalmefene
- Where
- 60 sites in Czechia, Estonia and 8 more
- Volunteers
- 665 people
- Sponsor
- H. Lundbeck A/S
Alcohol Dependence
Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) fMRI Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene
- Trial name
- NCT01969617
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- H. Lundbeck A/S
Alcohol Abuse, Alcohol Dependence
Remote Brief Intervention and Referrals to Treatment Service for Alcohol
The traditional paradigm that relies upon training physicians and nurses or uses on-site interventionists to perform screening, brief intervention, and referral to treatment (SBIRT) for alcohol has proven unsustainable in most…
- Trial name
- RBIRT (NCT02622984)
- Testing
- RBIRT, SBIRT
- Where
- United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Polaris Health Directions
Alcoholism
Study of Aripiprazole in Subjects With Alcoholism
The purpose of this clinical research study is to learn whether subjects treated with aripiprazole are able to abstain from alcohol use for a greater number of days than subjects treated with placebo.
- Trial name
- NCT00082199
- Testing
- Aripiprazole
- Where
- 14 sites in United States
- Volunteers
- 400 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Motivational Interviewing, Alcohol Use Disorder
ClientBot: a Conversational Agent That Supports Skills Practice and Feedback for Motivational Interviewing
This multi-stage study includes qualitative interviews, usability research, and a randomized training study of technology implementation in a real-world clinical setting.
- Trial name
- NCT05479890
- Testing
- ClientBot
- Where
- United States
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Lyssn.io, Inc.
Substance-related Disorders, Alcohol and Other Substance Use Prevention
Evaluating Feasibility, Acceptability, Usability, and an Initial Estimate of Effect of a Novel Training Platform on Peer Recovery Supporter Skill, Adherence, and Knowledge Gain-Phase I
This pilot study evaluates the feasibility, usability, and acceptability of the Thrive Digital Peer Platform (TDPP), an online training system for Peer Recovery Support Specialists (PRSS).
- Conditions
- Substance-related Disorders, Alcohol and Other Substance Use Prevention, Alcohol and Other Drug Use Disorders
- Trial name
- NCT07090590
- Testing
- Thrive Digital Peer Platform (TDPP)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Thrive Digital Health, LLC
Alcohol Use Disorder (AUD)
Evaluate the Efficacy and Safety of Naltrexone Hydrochloride Implant in Patients With Alcohol Use Disorder
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. The study plans to enroll 240 adult patients with Alcohol Use Disorder (AUD).
- Trial name
- AUD (NCT07433413)
- Testing
- Naltrexone
- Volunteers
- 240 people
- Sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
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