Clinical trials: Alcoholism
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
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.
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
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
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.
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.
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
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
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.
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
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
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 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 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 Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)
The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group…
- Trial name
- NCT02364947
- Testing
- Nalmefene hydrochloride
- Where
- 7 sites in Japan
- Volunteers
- 678 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
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
Pilot Evaluation of the Empower Neuromodulation System in AUD Patients
This study evaluates the effects of peripheral nerve stimulation on alcohol craving and consumption in participants with alcohol use disorder (AUD).
- Trial name
- NCT03983317
- Testing
- Empower Neuromodulation System
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Theranova, L.L.C.
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
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.