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180 active trials for 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 psychological counseling. Randomization will be stratified by gender and level of alcohol consumption prior to enrollment in the study

Start: February 2020

Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH

Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize patient outcomes. The proposed randomized clinical trial will examine the implementation and effects of integrated, person- and computer-delivered alcohol treatment compared to standard care on alcohol use (assessed by self-report and biomarker), mood, quality of life and survival following AH-LT. Predictors of 12-month post-transplant alcohol outcomes will be explored to allow future improved tailoring and targeting of these treatments.

Start: November 2020

Cognitive Enhancement Through Computerized Training

Alcohol use disorder is characterized by widespread neurocognitive impairments, however despite substantial advances in the intervention and treatment of alcohol use disorders, exceptionally few studies have been directed to improving these deficits. This project leverages computerized cognitive training, applied as an adjunct to inpatient treatment, to enhance neurocognitive recovery. This project informs public health and future intervention efforts by interrogating factors critical to intervention efficacy and clarifying relationships between neurocognitive recovery and treatment outcomes, including post-discharge alcohol consumption.

Start: April 2021

Cannabidiol as a Treatment for AUD Comorbid With PTSD

This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.

Start: September 2019

Targeting Sleep Homeostasis to Improve Alcohol Use Disorder Treatment Outcomes (M-STAR Study)

Insomnia is common in people who are in treatment for alcohol use disorder. It can impact both sleep quality and daytime functioning, as well as make it harder to treat the underlying alcohol use disorder. This study is looking at two types of therapy to help manage insomnia specifically for people also in treatment for alcohol use disorder.

Start: November 2020

Development and Testing of a Just-in-Time Adaptive Smart Phone Intervention to Reduce Drinking Among Homeless Adults

Homeless adults are 8 times as likely to be alcohol dependent compared with adults in the general population, yet few studies have examined the precipitants of alcohol use in this vulnerable population. Ecological momentary assessments (EMAs) that involve repeated assessment of thoughts/mood/behaviors (e.g., via smart phone) is currently the most accurate way to assess individuals in real-time in their natural environments. Advances in smartphone technology also allow for the collection of continuous geolocation and other passive sensing data. Thus, researchers can now link environmental risks and protective factors to outcomes, without reliance on subjective reporting alone. Building on prior work, this study will use a three-phase study to develop and test a "just in time" adaptive intervention to reduce alcohol use in homeless men and women. Phase I will use smartphones and passive sensing technologies to monitor geolocation, psychosocial variables (e.g., stress, affect, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are receiving shelter-based treatment. Phase I will identify environmental (i.e., geolocation), cognitive, and behavioral antecedents of alcohol use over 4 weeks. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent drinking. The resulting app will assess imminent risk of alcohol use after each EMA and will deliver relevant treatment messages that match a person's current risk factors. Phase III will test the feasibility, acceptability and preliminary efficacy of the app in a sample of 40 homeless adults with an AUD who receive the EMA plus treatment messages over 4 weeks. Drinking will be determined via self-report, supplemented by a transdermal alcohol sensor (i.e., SCRAM) worn by participants. This project will be the first to combine geolocation and psychosocial variables to identify real-time antecedents of drinking. If effective, this smartphone app could significantly improve treatment engagement, drinking outcomes, and quality of life among homeless adults with alcohol use disorders.

Start: February 2019

Adapting an Effective CBT for Comorbidity to a Computer-Delivered Format

Up to one-half of those in treatment for alcohol use disorder (AUD) has a co-occurring anxiety disorder ("comorbidity"), a condition that marks a high degree of treatment resistance, severity and relapse risk in AUD treatment patients. The investigators conceptualize comorbidity as a feed-forward system ("vicious cycle", [VC]) of interacting negative affect/stress, drinking motives/behavior, coping skills deficits, environmental circumstances, and neurobiological adaptations. Based on this model, the investigators developed and validated the VC cognitive-behavioral therapy (VC-CBT) to disrupt this system at several key linkage points. In a recently completed randomized controlled trial (RCT), the investigators found that adding the VC-CBT to standard AUD inpatient treatment resulted in better alcohol outcomes 4 months following treatment than did adding an anxiety treatment or standard

Start: June 2018

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.

Start: October 2016

Decreasing Alcohol Use Through Student Peer Leaders

Problematic alcohol use can lead to worse social and health related consequences for underserved minorities, requiring urgent intervention. By training underserved minority health professional students, this proposed project will develop and test the feasibility of an innovative and culturally tailored intervention for adults studying at a minority institution, with specific focus on alcohol screening, brief intervention, and referral of treatment (SBIRT). This proposal is expected to have a positive impact on alcohol reduction and prevention for minority communities

Start: August 2021

Feasibility of Emergency Department Initiated Extended-Release Naltrexone for the Treatment of Alcohol Use Disorder

This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical), case management and tele-addiction medicine services for treatment of alcohol use disorders in the ED. Alcohol use contributes to a large number of emergency department (ED) visits and the rate of alcohol-related ED visits is increasing. There is evidence that this increase may be driven by a subset of patients who frequently visit the ED due to an underlying alcohol use disorder (AUD). The proposed study will assess the feasibility of implementing a multimodal treatment for AUD in the emergency department for 25 patients with AUD and frequent ED visits related to alcohol use. The rationale for including each component of the multimodal treatment is outlined below. Pharmacotherapy is recommended as the standard of care for alcohol use disorders. Of the four drugs approved by the FDA for treatment of alcohol use disorder, extended release naltrexone has been found to be superior at reducing healthcare utilization, increasing detoxification facility use, and reducing total cost. Fewer than 1 in 4 patients with AUD currently receives treatment with an FDA approved agent and use of these drugs in EDs is virtually non-existent. In addition to higher rates of alcohol and substance use, patients who frequently visit the ED often suffer from multiple medical, mental health, and social problems that influence their health. Providing such patients with case management services has shown promise in improving health related outcomes while curbing ED utilization and healthcare costs. Limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access to care based on income level. Telemedicine is the remote diagnosis and treatment of patients via interactive telecommunication equipment. It has been used effectively to improve access to mental health care in a variety of patient populations, including in the ED. The primary hypothesis is that this multimodal treatment will reduce ED visits related to alcohol use. ED utilization in the 12 months before and after initiating treatment will be compared evaluate treatment efficacy.

Start: August 2020

Neurocognitive and Neurobehavioral Mechanisms of Change Following Psychological Treatment for Alcohol Use Disorder

Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change. The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions. It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.

Start: November 2018

Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial

This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of DBS for AUD. Patients who meet inclusion and exclusion criteria will be identified and recruited from the practices of Sunnybrook psychiatrists. Five (5) to ten (10) subjects will be enrolled and study duration for each patient will be of one (1) year. Our primary objective is to establish the safety of DBS in a patient population with treatment refractory AUD. In addition to demonstrating safety, our second primary objective will be to evaluate if DBS-targeted nucleus accumbens in alcoholism is efficacious in the treatment-refractory patients with AUD. This will be measured by various outcome measures that will include validated scales to assess addiction and craving behaviours.

Start: May 2018

Internet-based A-CRA for Young Adults With Problematic Alcohol Use

The primary aim of the study is to evaluate the feasibility and efficacy of an internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA) with therapist support for young adults (aged 18-24 years) with problematic alcohol use and their caregiver/significant other. Secondary aims include investigating the role of comorbid emotional symptoms, emotion regulation and prosocial behavior in treatment outcomes for the young adults. In a randomized controlled trial, participants (n = 60 young adults as well as an accompanying caregiver/significant other) will be recruited from the community through advertisements as well as through clinic referrals in Stockholm, Sweden. Eligible participants will be randomized either to the 10-week I-A-CRA treatment or to an active control group (receiving psychoeducation about alcohol use over the same time frame). In both conditions an accompanying caregiver/significant other will receive a support program in conjunction with the young adult's treatment. Participating young adults will be evaluated with regards to their alcohol use, psychiatric symptoms, emotion regulation, and prosocial behavior at pre-treatment, weekly during treatment, post-treatment, and at a 3-month follow-up. The primary outcome will be feasibility (measured as number of treatment completers; i.e., having completed 5 out of 8 treatment modules), and reductions in heavy drinking episodes (measured weekly by self-reported alcohol consumption, change from baseline in number of heavy drinking episodes/week). Secondary outcomes will include pre- and post-treatment self-rated levels of depression, anxiety and stress, emotion dysregulation, and prosocial behavior. Self-reports regarding stress, emotion dysregulation, and prosocial behavior will be complemented by behavioral measures (computerized tasks with eye-tracking). We hypothesize that treatment will be superior as compared to the control condition in reducing the number of heavy drinking episodes/week pre to post treatment, and reducing comorbid symptoms of stress, anxiety and depression.

Start: September 2020

Revolutionizing Normative Re-education

Personalized Normative Feedback (PNF), the most widely-used college alcohol intervention approach, suffers from several limitations innovatively remedied in the current proposal through CampusGANDR, a smartphone-based app for college students that delivers alcohol-related PNF within a weekly game centered around testing first-year students' perceptions about the attitudes and behaviors of their peers in a variety of campus-relevant domains. Five pilot studies suggest that CampusGANDR will be significantly more effective at correcting students' normative misperceptions and reducing their alcohol use than standard PNF, especially among heavier-drinking students and those with greater exposure to alcohol on social media, and that these larger effects are driven by the significantly decreased psychological reactance experienced by students when viewing feedback as part of a game about college life rather than as part of an alcohol-focused program. The current project seeks to 1) evaluate the efficacy of CampusGANDR in a large-scale multi-site trial, 2) identify the optimal dosage of alcohol feedback to deliver within CampusGANDR for correcting norms and reducing alcohol use across 12 weeks of gameplay among non-drinking, moderate-drinking, and heavy-drinking students, 3) examine person-level moderators of these effects, and 4) evaluate CampusGANDR engagement and sustainability among students who play voluntarily but are not involved in the randomized controlled trial.

Start: August 2021

Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes

Alcohol dependence is among the most common and costly public health problems affecting the nation. Among individuals with alcohol use disorder (AUD), those with (vs. without) a co-occurring anxiety disorder (AnxD) are as much as twice as likely to relapse in the months following AUD treatment. Dysregulation of biological stress-mood systems predict and correlate with AUD relapse and AnxD symptomatology. In contrast, stress system re-regulation correlates with improved AUD treatment outcomes but has not been examined with respect to AUD recovery and relapse in co-occurring AUD+AnxD.

Start: October 2018

Phone-based Safety Monitoring of Baclofen Prescriptions for Alcohol Use Disorder

BACLOPHONE is a prospective multicenter cohort study, conducted in two nearby French regions (Hauts-de-France and Normandie). BACLOPHONE consists of the monthly phone-based monitoring of 792 patients during their first year of baclofen prescription for alcohol use disorder. The main objective of the study is to determine the rate of patients who stop baclofen due to an adverse event (AE) in the first year of treatment.The BACLOPHONE study also aims to determine which types of AEs and serious AEs are actually liable to baclofen, and which other types are more likely the consequence of confounding factors, e.g., concomitant alcohol, psychotropic medications or substance uses, and comorbidities.

Start: December 2015

Study of Retinal Function Using Electroretinogram in Regular Alcohol Users

Alcohol is a major public health problem and its neurotoxic effects are, among other things, responsible for altering the functioning of cerebral neurotransmission pathways. The retina is an anatomical and developmental extension of the central nervous system. It is composed of several layers of retinal neurons that share similar anatomical and functional properties with brain neurons. Retinal neurons are notably equipped with a complex system of neurotransmission constituted by the main neurotransmitters that are involved in the central effects of alcohol: glutamate, dopamine, serotonin ... The retina is used here as a site of indirect investigation for abnormal central neurotransmission pathways following regular alcohol use. It is recognized to date as a good site for investigating central abnormalities in neuropsychiatric and addictive disorders. The objective of this project is to study the retinal function using electroretinogram (ERG) in regular alcohol users to isolate potential markers of cerebral neurotransmission abnormalities.

Start: May 2019

Facilitating Alcohol Screening and Treatment (FAST)

Alcohol use is the third leading cause of death in the United States. Primary care practices need to implement new research findings that help identify and treat alcohol use disorder. This project will compare two methods of supporting small and medium size primary care practices in Colorado to improve their alcohol screening and treatment.

Start: May 2020

Training Inhibition in Alcohol Use Disorder

More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.

Start: February 2019

Effect of Allopregnanolone on Stress-induced Craving

The goal of this study is to determine whether intravenous infusion of allopregnanolone (ALLO) attenuates stress-induced craving and stress-induced anxiety in a clinical laboratory setting. The secondary objective of this project is to characterize the behavioral effects of ALLO in heavy drinkers.

Start: July 2019