Clinical trials: Alcohol Dependence
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.
Suicide, Suicide, Attempted
Drivers of Suicide Mobile App Study
The central purpose of this project is to evaluate and facilitate access to evidence-based best practices for individuals struggling with suicidal ideation and co-occurring behavioral problems, including alcohol misuse, and…
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation, Alcohol Use Disorder
- Trial name
- NCT05427734
- Testing
- WisePath for Adults, Active-Control app + electronic wellness resources brochure
- Where
- United States
- Volunteers
- 127 people
- Sponsor
- Evidence-Based Practice Institute, Seattle, WA
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
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
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.
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.
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
Alcohol Dependence
Efficacy of Nalmefene in Patients With Alcohol Dependence
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
- Trial name
- ESENSE1 (NCT00811720)
- Testing
- Nalmefene
- Where
- 39 sites in Austria, Finland and 2 more
- Volunteers
- 598 people
- Sponsor
- H. Lundbeck A/S
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
Mental Health
An Evaluation of Innerview™, a Web-based Tool to Support the Integration of Mental Health in the Primary Care Setting
Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating…
- Trial name
- NCT02025647
- Where
- 5 sites in United States
- Volunteers
- 139 people, healthy volunteers welcome
- Sponsor
- Pearson/Clinical Assessment
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 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.
Alcohol Use Disorder (AUD), Substance Use Disorders
Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use
Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and…
- Trial name
- NCT04974645
- Testing
- W-SUDs, Digitally-delivered Psychoeducation
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Woebot Health
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 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
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.
- Trial name
- NCT02382276
- Testing
- Nalmefene hydrochloride
- Where
- 7 sites in Japan
- Volunteers
- 405 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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
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 (AUD), Substance Use Disorders
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder…
- Trial name
- NCT04925570
- Testing
- W-SUDs, Digitally-delivered Psychoeducation
- Where
- United States
- Volunteers
- 258 people
- Sponsor
- Woebot Health
Alcohol Dependence
Efficacy of Nalmefene in Patients With Alcohol Dependence
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
- Trial name
- ESENSE2 (NCT00812461)
- Testing
- Nalmefene
- Where
- 57 sites in Belgium, Czechia and 5 more
- Volunteers
- 678 people
- Sponsor
- H. Lundbeck A/S