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180 active trials for Alcohol Use Disorder

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

The primary objectives of this study are twofold. The first primary objective is to evaluate the feasibility, acceptability, and tolerability of atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) as compared to placebo for 6 weeks plus a psychosocial platform comprised of motivational enhancement therapy and cognitive behavioral therapy (MET-CBT) among adolescents (ages 14 to 19 years) with alcohol use disorder as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). The second primary objective is to leverage a human laboratory paradigm and ecological momentary assessment (EMA) methods to evaluate the effects of atomoxetine on intermediate phenotypes associated with alcohol use and outcomes in clinical trials.

Start: March 2021

Stress, Emotion Regulation, and Alcohol in Women Veterans

The purpose of the study "Stress, Emotion Regulation, and Alcohol in Women Veterans" is to learn about the effects of negative emotion and stress on behavior (including alcohol use) among women Veterans, including women with and without posttraumatic stress disorder. Additionally, the study looks at whether a woman's use of emotion regulation techniques changes the association between stress or negative emotion and behavior. Lastly, the study examines how women's reactions to stress, and the effects of stress, vary across the menstrual cycle - depending on the level of circulating hormones.

Start: July 2020

Online Cognitive Behavior Therapy for Comorbid Sleep Problems in Alcohol Use Disorder

The main goal is to study the effects of internet-delivered cognitive behavioural therapy with minimum guidance for comorbid sleep problems in alcohol use disorder, in routine addiction care.

Start: April 2020

Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Start: February 2021

Clinical Intervention in Alcohol Use Disorder

Long-term abstinence from alcohol is supported by a compensatory mechanism in functional brain connectivity, a potential brain biomarker that could be an intervention target. These findings provide a compelling case to explore whether this brain biomarker can be modulated to enhance patients' ability to remain abstinent. There is a need to investigate methods that can be used to increase functional brain connectivity. The overall objective of this proposal is to enhance brain functional connectivity in short-term abstinent alcoholics as a therapeutic intervention that supports abstinence.

Start: July 2016

Sex Differences in the Response to Abstinence From Alcohol.

In laboratory animals, repeated cycles of abstinence from and return to alcohol drinking can lead to changes in alcohol intake. In a study of the effect of abstinence on drinking in humans, the investigators found evidence that abstinence affects drinking differently in women compared to men. In the present study, the investigators propose to study how men and women respond to abstinence, and whether this information can be used to improve intervention and prevention strategies.

Start: April 2019

Quality of Life in Patients With Alcohol Use Disorder

The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

Start: February 2021

VRT as a Biomarker of Cerebellar Dysfunction in Chronic Cannabis Use

Chronic cannabis consumption has been associated with poor psychosocial functioning that could be associated to cerebellar dysfunction. The cerebellum has a relevant role in adaptation processes and has a high density of cannabinoid 1 receptor (CB1R). Implicit motor learning is a cerebellum dependent function that can be measured with a visuomotor rotation task (VRT). The project aims to identify a sensitive and specific biomarker of cerebellum dysfunction in chronic cannabis users. The investigators would like to demonstrate that the visuomotor rotation paradigm is valid to measure and quantify such a dysfunction. A longitudinal prospective study with a 3 month follow-up is proposed. 3 groups will be included: 1) chronic cannabis users; 2) individuals with an alcohol use disorder; and 3) healthy controls. All groups will be matched by sex and age. Forty individuals will be included in each group. Individuals will be assessed at baseline, at first month and at 3-months of follow-up. Sociodemographic and clinical data will be recorded. Information on cannabis consumption will be registered using an App. Participants will do the visuomotor rotation task and answer three questionnaires: the Intrinsic Motivation Inventory, the Scale for the assessment and rating of ataxia (SARA) and the Harris tests for lateral dominance. The biomarker developed by this project will facilitate the detection of cerebellar alterations in chronic cannabis users, and will permit to quantify and monitor such alteration over time. The team's intention is to patent the proposed model and disseminate it in order to use it in clinical practice at both primary and specialized health centres.

Start: September 2019

Using Transcutaneous Auricular Vagus Nerve Stimulation to Treat Acute Alcohol Withdrawal

The purpose of this study is to see if stimulation of the vagus nerve via a non-invasive device placed behind external ear can reduce physical and psychological discomfort during acute alcohol withdrawal in patients with alcohol use disorder when people just stop drinking alcohol and in detoxification stage.

Start: July 2021

Alcohol and Cigarette Craving During Oxytocin Treatment

This proposed research seeks to examine the behavioral and neural substrates of intranasal oxytocin compared to placebo on alcohol cue-induced alcohol and cigarette craving smokers with an alcohol use disorder (AUD). Non treatment-seeking smokers with an AUD will be recruited to participate in a between-subjects, placebo-controlled, randomized pilot functional magnetic resonance imaging (fMRI) study. Participants will undergo an fMRI scan in conjunction with an alcohol-olfactory cue-reactivity task. Secondary assessments will include alcohol and cigarette craving, alcohol and cigarette consumption, physiological measures (heart rate and blood pressure) and mood measures.

Start: November 2020

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.

Start: October 2019

Feasibility Trial of Pregnenolone for Posttraumatic Stress Disorder and Alcohol Use Disorder

Pregnenolone is a neurosteroid and an over-the-counter supplement that has shown promise in clinical studies of stress-related disorders, such as anxiety, depression and posttraumatic stress disorder (PTSD). Epidemiological studies suggest that patients with PTSD are at higher risk of developing addiction, including alcohol use disorder (AUD).The following hypothesis will be tested in this trial: pregnenolone is associated with a reduction in both PTSD symptoms and the number of standard drinks per week in outpatients with PTSD and AUD.

Start: May 2021

Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)

The purpose of this research study is to learn about people who use the National Suicide Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would also like to learn whether people who have experienced a suicidal crisis could benefit from participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.

Start: October 2020

Ketamine for the Rapid Treatment of Major Depressive Disorder and Alcohol Use Disorder

The investigators will compare 3 treatment groups (ketamine plus naltrexone vs. ketamine alone vs. placebo) for treating major depressive disorder (MDD) and alcohol use disorder (AUD) in an 8-week randomized, double-blind, placebo-controlled, between-subjects trial. First, prior to the double-blind trial, the investigators will conduct an open-label trial that will include 5 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) with a follow-up of 4 weeks. Second, after reviewing the safety and efficacy of repeated ketamine treatment from the open-label trial, the investigators will conduct an 8-week, randomized, double-blind, placebo-controlled trial that will include 60 patients with comorbid MDD and AUD to test safety and efficacy of repeated ketamine treatment (0.5 mg/kg; once a week for 4 weeks; a total of 4 ketamine infusions) plus naltrexone with a follow-up of 4 weeks. The 4-month follow-up session will also occur.

Start: January 2015

Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)

This study will evaluate the behavioral effects of alcohol during maintenance on placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using sophisticated human laboratory methods.

Start: September 2018

Behavioral Alcohol Responses (BAR) Study

This study aims to identify risk factors that prospectively predict alcohol problems in young adults.

Start: February 2018

Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Start: July 2020

Role of BP1.3656 on Alcohol Responses

The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).

Start: February 2021

Probenecid as Medication for Alcohol Use Disorder

The design is a randomized, within-subject, crossover, double-blind, placebo-controlled human alcohol laboratory study with one oral dose of 2g probenecid or placebo administered in two laboratory sessions.

Start: December 2020

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. Keeping in mind the high burden of disease due to AUD, limited efficacy of available treatment modalities it is important to study new treatment modalities. Vagus nerve stimulation (VNS) is a promising neuromodulation technique with robust evidence in epilepsy and treatment-resistant depression. fMRI studies show that transcutaneous VNS (tVNS) replicates most of the biological effects of VNS with an additional advantage of being non-invasive. Percutaneous Electrical Neural Field Stimulation (PENFS) of auricular branch of vagus nerve is a variant of tVNS which has shown promise in the treatment of opioid withdrawal. The efficacy of PENFS has been evaluated in AUDs in only handful of studies. I propose to employ a double-blind randomized sham-controlled trial where 40 subjects with AUD will be randomized to 2 groups, with 1 group receiving 'Active' auricular PENFS, and another group receiving bilateral 'sham' auricular PENFS. Assessments will be carried out at baseline and after 15 days of advent of PENFS on tasks to assess craving, along with neurohemodynamic changes on functional Magnetic Resonance Image (fMRI). Follow up of patients will be done till the first relapse or till 3 months after the post evaluation, whichever is earlier. The investigator's hypotheses are: Active PENFS will lead to significantly greater improvement in subjective craving and drinking-related outcomes as compared to sham PENFS in patients with AUD over the follow-up period of 3 months. Active PENFS will produce a significantly differential Blood Oxygen Level Dependent (BOLD) activation-deactivation pattern of brain regions (greater activation of dorsolateral prefrontal cortex and anterior cingulate cortex and along with deactivation of insular cortex) associated with craving during a cue-induction paradigm as compared to sham PENFS in patients with AUD. Active PENFS will result in a significant differential change in resting-state functional connectivity (fMRI measured) within and between addiction-related neural networks as compared to sham PENFS as evaluated with a resting state fMRI analysis in patients with AUD.

Start: October 2019