Clinical trials: Alcohol-dependence
Alcohol Use Disorder (AUD), Alcohol Dependence
Evaluation of the Efficacy of Sodium Oxybate in the Long-term Maintenance of Abstinence in Alcoholic Patients
Additional pharmacotherapies in the treatment of alcohol dependence are needed. Sodium oxybate showed efficacy in the maintenance of abstinence in alcohol-dependent patients in several small randomized trials of short duration.
- Trial name
- GATE2 (NCT04648423)
- Testing
- Sodium Oxybate
- Volunteers
- 314 people
- Sponsor
- Laboratorio Farmaceutico Ct S.r.l.
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 Abuse, Alcohol Abuse/addiction
A Study of the Safety and Exploratory Efficacy of Oral AFA-281 in Patients with Alcohol Use Disorder
This study will evaluate the safety and exploratory efficacy of AFA-281 in patients with Alcohol use disorder on cravings, subjective response to alcohol, pain thresholds, anxiety, depression, and sleep.
- Conditions
- Alcohol Abuse, Alcohol Abuse/addiction, Anxiety, Pain Threshold
- Trial name
- NCT06710431
- Testing
- AFA-281
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Afasci Inc
Alcohol Dependence
A Study of Brain Receptor Occupancy in Healthy Subjects
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
- Trial name
- NCT01232439
- Testing
- opioid receptor kappa antagonist
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
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 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
Substance Dependence, Alcohol Dependence
Effects of GSK598809 on Brain Activation in Abstinent Alcoholics
This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers. A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like the real drug.
- Trial name
- NCT00908206
- Testing
- GSK598809
- Sponsor
- GlaxoSmithKline
Substance Use Disorders, Alcohol Use Disorder
W-SUDs for COVID-19
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.
- Trial name
- NCT04460027
- Testing
- Woebot Substance Use Disorder
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Woebot Health
Alcohol Use Disorder, Alcoholism
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment.
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Abuse, Alcohol Dependence
- Trial name
- NCT07216872
- Testing
- Deep TMS (DTMS)
- Where
- 11 sites in United States, Israel and 1 more
- Volunteers
- 186 people
- Sponsor
- Brainsway
Alcohol Dependence
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients
The purpose of the study is to assess the efficacy of Xylka® (baclofen) compared to placebo on continuous abstinence rate during 20 weeks of treatment, after withdrawal, in alcohol dependent patients receiving Brenda therapy…
- Trial name
- ALPADIR (NCT01738282)
- Testing
- Baclofen
- Where
- 38 sites in France
- Volunteers
- 316 people
- Sponsor
- Ethypharm
Alcohol Dependence
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of RDC-0313 following oral administration.
- Trial name
- NCT00800319
- Testing
- RDC-0313
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Alcohol Addiction
Soberlink - MAP Outcomes Study Protocol
The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD)…
- Trial name
- NCT03190356
- Testing
- Soberlink Cellular Device
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Soberlink Healthcare LLC
Alcohol Use Disorder
A Study of New Treatment for Excessive Alcohol Users by Electric Stimulation of Nerves Around Ear
Alcohol Use Disorders (AUD's) are a major health and social problem. Relapse is a rule rather than an exception in alcohol dependence, leading to poor outcomes. Craving are frequently associated with relapse.
- Trial name
- NCT04106739
- Testing
- Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)
- Where
- India
- Volunteers
- 44 people
- Sponsor
- DyAnsys, Inc.
Alcohol Dependence
A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects
The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.
- Trial name
- NCT02679469
- Testing
- nalmefene hydrochloride 10 mg
- Where
- Japan
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Substance Use Disorder, Drug Dependence,
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have…
- Conditions
- Substance Use Disorder, Drug Dependence,, Alcohol Dependence
- Trial name
- NCT02173041
- Testing
- Prevention Awareness Groups (PAG), Standard Care
- Where
- India
- Volunteers
- 152 people
- Sponsor
- Macmillan Research Group UK
Alcohol Dependence
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months.
- Trial name
- NCT00981617
- Testing
- ALKS33 (RDC-0313) (1 mg), ALKS33 (RDC-0313) (2.5 mg), ALKS33 (RDC-0313) (10 mg)
- Where
- 27 sites in United States
- Volunteers
- 406 people
- Sponsor
- Alkermes, Inc.
Alcohol Abuse
Adaptive Goal-Directed Adherence Tracking and Enhancement
Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which uses the text messaging and internet capabilities of modern cellular phones to address the problem of medication adherence in clinical…
- Trial name
- AGATE (NCT01349985)
- Testing
- AGATE, SASED
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Talaria, Inc
Alcohol Use Disorder
A Study of Brenipatide in Participants With Moderate-to-Severe 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 moderate-to-severe Alcohol Use Disorder (AUD). Participation in this study will last approximately 56 weeks.
- Trial name
- RENEW-ALC-1 (NCT07219966)
- Testing
- LY3537031
- Where
- 117 sites in United States, Belgium and 6 more
- Volunteers
- 1,100 people
- Sponsor
- Eli Lilly and Company
Alcohol Use Disorder (AUD)
A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder
TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances. It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious…
- Trial name
- LIBERATE-A (NCT06648655)
- Testing
- TMP-301
- Where
- 14 sites in United States
- Volunteers
- 110 people
- Sponsor
- Tempero Bio, Inc.