Clinical trials: Alcohol Use Disorder (AUD)
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 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.
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 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 (AUD)
Sleep and Emotional Reactivity in Alcohol Use Disorder
Alcohol use disorder (AUD) is a multifaceted, chronic relapsing disorder suffered by millions of men and women in the United States.
- Trial name
- SEAS (NCT04979507)
- Testing
- Uninterrupted sleep followed by functional neuroimaging.
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- SRI International
Alcohol Use Disorder
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD).
- Trial name
- NCT05646303
- Testing
- Psilocybin
- Where
- 12 sites in Canada, Finland
- Volunteers
- 128 people
- Sponsor
- Clairvoyant Therapeutics
Alcohol Use Disorder
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with…
- Trial name
- NCT05913752
- Testing
- CMND-100
- Where
- 4 sites in United States, Israel
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Clearmind Medicine Inc.
Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD)
Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder
In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2…
- Conditions
- Alcohol Abuse With Alcohol-Induced Sleep Disorder, Alcohol Use Disorder (AUD), Sleep Disorder, Sleep Disturbance
- Trial name
- NCT06108115
- Testing
- CueToSleep (Full Intervention Package)
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- HealthRhythms, 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.
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.
AUD
Phase II Clinical Study on the Efficacy and Safety of Naltrexone Implant in Patients With Alcohol Use Disorder
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial. The study plans to enroll 210 adult patients with alcohol use disorder.
- Trial name
- NCT07333638
- Testing
- low-dose group (naltrexone implant 0.9 g + general supportive psychological counseling), high-dose group (naltrexone implant 1.5 g + general supportive psychological counseling)
- Where
- China
- Volunteers
- 210 people
- Sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
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.
AUD
Exploring the PK of Different Doses of Naltrexone in Patients With AUD
Study Design This study is related to a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of different doses of naltrexone implants in the treatment of patients…
- Trial name
- NCT05919017
- Testing
- Naltrexone implant
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
Alcoholism, Alcohol Abuse
EMPOWER AUD Pivotal Trial
Multi-site, double-blinded, prospective, randomized, sham-controlled study
- Conditions
- Alcoholism, Alcohol Abuse, Alcohol Use Disorder
- Trial name
- NCT05948605
- Testing
- Empower Neuromodulation System
- Where
- 2 sites in United States
- Volunteers
- 35 people
- Sponsor
- Theranova, L.L.C.
Anxiety Disorders, Alcohol Use Disorder
Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)
CT fibers are found in the skin of most mammals and project to the insular cortex. Stimulation of CT fibers by light touch causes a release of oxytocin and is associated with feelings of comfort and wellbeing.
- Conditions
- Anxiety Disorders, Alcohol Use Disorder, Stress, Psychological
- Trial name
- NCT06224127
- Testing
- active heat, Active c tactile fiber stimulation
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Soovu Labs 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.
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 Use Disorder, Alcohol Dependence
Tech-Enabled CM for AUD at Scale
This Phase II Small Business Innovative Research (SBIR) project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health's innovative smartphone/smart debit card remote digital…
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Drug Dependence
- Trial name
- NCT04581499
- Testing
- DynamiCare Motivation Support Program, Untreated or Routine Care Control Group
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- DynamiCare Health
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.