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180 active trials for Alcohol Use Disorder

Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT)

Alcohol Behavioral Couples Therapy (ABCT) is a manualized 12-session, weekly psychosocial intervention that simultaneously reduces alcohol use disorder (AUD) severity and improves relationship functioning. However, there remains room to improve ABCT outcomes. A growing literature suggests that intranasal oxytocin is a medication that holds promise to achieve that goal. Oxytocin has demonstrated the ability to increase prosocial behavior (e.g., trust, safety, social cognition) and restore sensitivity to natural rewards such as interpersonal relationships that are commonly eroded in the context of addiction. Oxytocin has also demonstrated the ability to reduce substance use behaviors (e.g., craving, self-administration, tolerance, withdrawal), and improves the neurobiological foundations of AUD. The primary objective of this Stage II study is to test the efficacy of oxytocin versus placebo in improving (1) AUD symptom severity, (2) relationship functioning, and (3) corticolimbic connectivity among couples receiving ABCT therapy.

Start: May 2019

Testing an Online Insomnia Intervention

The objective of this trial is to determine the effectiveness of an electronic cognitive behavioral therapy for insomnia (e-CBT-I) module in improving sleep and reducing alcohol use among heavy drinkers with insomnia. Specifically, it will test the effectiveness of Sleep Healthy Using the Internet (SHUTi), a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. The rationale for this mixed methods proposal is that effective, nonpharmacologic treatments are necessary to stem the highly comorbid public health problems of alcohol use disorder (AUD) and insomnia. If successful, SHUTi will represent a novel and easily accessible intervention for reducing alcohol intake among high-risk heavy drinkers.

Start: September 2020

Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers

This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol consumption and craving

Start: July 2021

An Inflammatory Challenge Using Endotoxin

The study design consists of a randomized, double-blind, placebo-controlled trial of low dose endotoxin. The low dose endotoxin challenge induces a transient systemic inflammatory response with normalization of cytokine levels within hours. This "phasic" inflammation is distinct from chronic ("tonic") levels of inflammation that may be present with AUD. A total of 38 non-treatment seeking heavy drinking men and women and 38 light drinking healthy controls will participate in the study. Recruitment will be monitored to ensure the two groups are matched by gender. Eligible participants will be randomly assigned, stratified by gender and BDI-II severity, to receive a single I.V. infusion of either low dose endotoxin (0.8 ng/kg of body weight) or placebo (same volume of 0.9% saline solution) at the UCLA Outpatient Clinical and Translational Research Center (CTRC). All participants will complete an alcohol cue-exposure paradigm and reward responsiveness assessment 2 hours post infusion, which is the time of expected peak cytokine response. All participants will also complete an fMRI alcohol cue-reactivity paradigm at 3 hours post infusion. Plasma levels of proinflammatory cytokines [i.e., Interleukin-6 (IL-6) and tumor necrosis factor-? (TNF- ?)], mood, and alcohol craving, will be assessed at baseline and then hourly for four hours post infusion.

Start: June 2021

Using Neuroeconomics to Characterize State-Based Increases and Decreases in Alcohol Value

This study uses techniques from an area of research known as neuroeconomics, which integrates concepts and methods from psychology, neuroscience, and economics to better understand how people make decisions and how these decisions are supported by the brain. One neuroeconomic concept that is especially relevant in the area of addictions is substance demand, or how consumption of a commodity (e.g., alcohol, tobacco, or drugs) is influenced by price and other factors. Previous studies have shown that alcohol demand is related to severity of alcohol misuse, drinking quantity/frequency, and treatment outcomes. In addition, we know that alcohol demand can also fluctuate in response to environmental cues such as alcohol-related stimuli or external contingencies such as important responsibilities the following day. These increase and decreases in consumption and value are clinically significant because they help us understand how people with alcohol use disorders are able to successfully or unsuccessfully modulate their drinking behaviors. This study is examining how the brain responds in these situations and whether these responses differ as a function of severity of alcohol misuse. This study will use functional magnetic resonance imaging (fMRI) to understand brain activity patterns associated with changes in the value of alcohol in the presence of alcohol-related beverage cues relative to neutral-related beverage cue. Participants will be non-treatment-seeking adult heavy drinkers who are recruited from the community to participate in an fMRI scan. During the scan, participants will make decisions about how many alcohol beverages they would consume (hypothetically) at various prices while their brain activity during those decisions is measured. The first experimental manipulation involves an in-scanner alcohol cue exposure task in which the drinking decisions will be made after viewing high-quality images of alcoholic (beer/wine/liquor) beverages or neutral (water/juice/soft drinks) beverages.

Start: January 2020

Alcohol Use and Mental Health - Pilot Test of Video-assisted Drinking Topography

The overall goal is to pilot test and establish a procedure for video-assisted alcohol topography and explore its utility as an indicator of alcohol use disorder. There are 4 phases to this study: 1) pre-screening by phone; 2) in-person screening appointment; 3) the first alcohol drinking session with videotaping; and 4) follow-up appointment for retest.

Start: October 2017

Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users

Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).

Start: July 2015

Reducing Stigma Among Healthcare Providers (RESHAPE-cRCT)

A growing number of trials have demonstrated treatment effectiveness for mental illness by non-specialist providers, such as primary care providers, in low-resource settings. A barrier to scaling up these evidence-based practices is the limited uptake from trainings into service provision and lack of fidelity to evidence-based practices among non-specialists. This arises, in part, from stigma among non-specialists against people with mental illness. Therefore, interventions are needed to address attitudes among non- specialists. To address this gap, REducing Stigma among HeAlthcare Providers to improvE Mental Health services (RESHAPE), is an intervention for non-specialists in which social contact with persons with mental illness is added to training and supervision programs. A cluster randomized control trial will address primary objectives including changes in stigma (Social Distance Scale) and improved quality of mental health services, operationalized as accuracy of identifying patients with mental illness in primary care. The control condition is existing mental health training and supervision for non-specialists delivered through the Nepal Ministry of Health's adaptation of the World Health Organization mental health Gap Action Programme. The intervention condition will incorporate social contact with people with mental illness into existing training and supervision. Participants in the cluster randomized control trial will be the direct beneficiaries of training and supervision (primary care providers) and indirect beneficiaries (their patients). Primary care workers' outcomes include stigma (Social Distance Scale), knowledge (mental health Gap Action Programme knowledge scale), implicit attitudes (Implicit Association Test), clinical self-efficacy (mental health Gap Action Programme knowledge scale), and clinical competence (Enhancing Assessment of Common Therapeutic factors) to be assessed pre-training, post-training, and at 3- and 6-month follow-up. Accuracy of diagnoses will be determined through the Structured Clinical Interview for the Diagnostic and Statistical Manual version 5, which will be assessed at 3 months after patient enrollment. Patient outcomes include functioning, quality of life, psychiatric symptoms, medication side effects, barriers to care, and cost of care assessed at enrollment and 3 and 6 months. This study will inform decisions regarding inclusion of persons living with mental illness in training primary care providers.

Start: September 2021

Families With Substance Use and Psychosis: A Pilot Study

The purpose of this study is to develop and evaluate an intervention that adapts Community Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis and substance use delivered via telemedicine (video conferencing). The intervention aims to improve treatment engagement and reduce distress, and it will be delivered via telemedicine (CRAFT-FT). To assess feasibility of the intervention, family members will complete the sessions and provide feedback to refine the treatment manual. Data on client relatives with psychosis will be collected for preliminary assessment purposes. Client relatives will not complete the research study intervention.

Start: September 2020

CBD for the Treatment of Alcohol Use Disorder

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 8 weeks.

Start: June 2021

Pioglitazone for the Treatment of Alcohol Use Disorder

Alcohol Use Disorder (AUD) is common among Veterans but medication treatment is used infrequently and the impact of these treatments are small to moderate at best. Pioglitazone, a medication FDA approved for diabetes, has been shown in pre-clinical studies to reduce alcohol. The proposed study will test the efficacy of pioglitazone to reduce alcohol use in a double-blind placebo controlled trial. Investigators plan to compare pioglitazone to placebo in 200 Veterans who have an AUD and who are currently drinking alcohol at two Veterans Affairs Health Care Centers. The primary hypothesis is that Veterans with an AUD who are currently drinking alcohol will have a greater reduction in alcohol use following treatment with pioglitazone compared to those treated with placebo.

Start: July 2019

Treatment for Comorbid Social Anxiety and Alcohol Use Disorders.

Alcohol use disorders (AUD) and social anxiety disorder (SAD) are highly comorbid and associated with significant impairment. Social anxiety comorbidity is associated with poorer addiction treatment engagement and outcomes. Thus, addressing underlying SAD symptoms that may lead to and maintain alcohol problems, as well as undermine successful treatment for AUD, is warranted. This proposal aims to develop and evaluate a fully integrated outpatient program for comorbid SAD and AUD that weaves evidence-based treatment for SAD (i.e., exposure-based cognitive behavioral therapy) into a traditional, evidence-based treatment for AUD. First, the investigators will develop the protocol for the fully integrated treatment (FIT). The overarching goal of FIT will be to simultaneously deliver AUD and SAD treatment. Development will be an iterative process guided by previous research (including our own), and by input from clinicians, administrators, and patients in an outpatient substance use disorder treatment clinic. After the protocol is developed, the investigators will use their established clinician training procedures to train clinicians at their community partnered clinic to competently deliver the intervention. After protocol development and clinician training, the investigators will conduct a pilot randomized clinical trial (RCT) comparing the efficacy of our fully integrated treatment (FIT) for comorbid alcohol use and social anxiety disorders to usual care (UC) in the community substance use disorder specialty clinic. The goals of the RCT will be to gather data regarding acceptability, feasibility, and preliminary efficacy of the FIT protocol. The investigators will randomize treatment-seeking participants (N = 60) who have comorbid SAD and AUD. The investigators will assess treatment engagement, social anxiety outcomes, and alcohol use outcomes at baseline, 3-months, and 6-months from baseline. The investigators will also gather qualitative and quantitative acceptability data from patients after completing FIT, which may guide final refinements of FIT prior to testing in a larger-scale grant. The knowledge gained from this investigation has the potential to significantly improve the treatment of alcohol use disorders and make a significant public health impact. The focus on direct translation to community practice paradigms and the emphasis on full mental health and addiction treatment integration significantly advance the field.

Start: March 2018

Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD

The primary study objective is to determine the efficacy of pregabalin administered orally for a period of 12 weeks in reducing risky drinking and symptoms of posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The secondary objective is to assess the safety and tolerability of pregabalin in participants with alcohol use disorder and co-occurring posttraumatic stress disorder who have selected genotypes at the gamma-amino butyric acid transporter and receptor genes. The investigators will utilize a large and diverse sample of African-Americans that includes both genders and individuals with different types of trauma. All participants will receive standardized bi-weekly Brief Behavioral Compliance Enhancement Treatment (BBCET).

Start: September 2016

Identifying and Managing Alcohol-related Health Problems in General Practice

The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.

Start: October 2020

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Alcohol use disorders (AUDs) affect up to 60% of individuals with bipolar disorder during their lifetime-a rate 3 to 5 times higher than what occurs in the general population. The mechanisms that contribute to elevated rates of comorbidity are not known. Early identification in individuals with bipolar disorder who are at risk for AUDs could inform novel intervention strategies and improve life-long outcomes. The primary objective of this protocol is to use alcohol administration procedures and functional MRI techniques to investigate subjective response to alcohol, compared to placebo, and relationship with functional responses of, and connectivity among, brain regions in ventral prefrontal emotional networks in young adults with bipolar disorder and healthy comparison young adults. Baseline clinical and structural MRI assessments will be completed in 30 bipolar and 30 healthy young adults (21-26 years of age, 50% women). Then, following standard beverage administration procedures, participants will complete within-person, counter-balanced, fMRI scans and complete measures of subjective response to alcohol while under the influence of alcohol or placebo. Specifically, individual differences in the experience of stimulating, sedative, and anxiolytic effects of alcohol (measured with self-report surveys) and individual differences in neural responses to alcohol within ventral prefrontal emotional networks will be investigated and differences in bipolar disorder compared to healthy participants assessed. Functional MRI scans during a continuous performance task with emotional and neutral distractors (CPT-END) and at rest will be collected while under the influence of alcohol and placebo and compared. Experience of stimulating, sedative, and anxiolytic effects of alcohol from self-report survey data and neural responses to emotional stimuli while under the influence of alcohol compared to placebo will be the primary data outcomes assessed. Additionally, associations between subjective and neural response to alcohol and drinking patterns will be explored (secondary outcomes). The primary endpoint of the study will be after completion of both alcohol and placebo beverage conditions.

Start: July 2019

Black Church Treatment Study

This study will conduct a randomized clinical trial comparing levels of treatment initiation, engagement, and alcohol outcomes for a novel treatment strategy (CBT4CBT delivered in the Black church) compared with traditional outpatient specialty addiction treatment for a large sample of Black adults with AUD. The purpose of this randomized clinical trial is to determine which setting (church or specialty clinic) (1) has better treatment initiation and retention rates and (2) better AUD outcomes as measured by percentage of days abstinent (PDA) (8 weeks, 3, 6 and 9 months follow up).

Start: May 2021

"ALCO-VR": Virtual Reality Cue Exposure Therapy for the Treatment of Alcohol Use Disorder

Alcohol-related stimuli emerge as high-risk cues for individuals diagnosed with alcohol use disorder (AUD). Relapse after treatment remains a challenge in AUD. Attentional bias (AB) towards alcohol-related stimuli, alcohol craving and anxiety are factors contributing to relapse, even after completion of treatment. The current study aims to test the efficacy of a Virtual Reality Cue-Exposure Therapy (VR-CET) patients diagnosed with severe AUD, who made several failed attempts to cease alcohol drinking. It is expected that VR-CET is more efficient in reducing AUD symptomatology and preventing relapses than CBT. 80 participants will be randomly assigned to experimental or control group. Data regarding alcohol craving, anxiety and AB will be assessed prior to, at the end of and 3, 6 and 12 months after completion of the treatment. The experimental group will receive six VR-CET booster sessions over the course of five weeks. VR-CET booster sessions consist of exposure to preferred alcoholic beverages and alcohol-related contexts in a VR environment. Throughout the six VR-CET sessions, momentary anxiety and alcohol craving levels will be assessed. The control group will receive CBT.

Start: September 2018

The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility

Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD. This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims: Aim 1: Identify treatment targets that prospectively predict functional disability, family functioning and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD. To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time. H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.

Start: October 2018

Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda

Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.

Start: December 2020

Effects of tDCS Paired With Cognitive Training on Brain Networks Associated With Alcohol Use Disorder in Veterans

Alcohol misuse is an epidemic among Veterans in the United States. Nearly 1/3 of Veterans have a lifetime history of Alcohol Use Disorder (AUD). In 2014, there were 15,306 unique patients treated in inpatient VA treatment programs alone, which represents a 10.7% increase from just two years prior. Unfortunately, about 2/3 of those entering treatment will relapse within one year. Cognitive impairments found in chronic alcohol use interfere with adaptive behavior needed for successful recovery. However, these cognitive impairments and their underlying neural substrates may provide promising new targets for interventions that can reduce relapse rates. Evidence suggests that cognitive training can improve cognition in individuals with AUD, strengthen neural networks mediating cognition, and improve treatment outcome. However, cognitive training is effort intensive, has small effect sizes, and may have limited durability. The primary objective of this study is to investigate if transcranial direct current stimulation (tDCS) can increase the effectiveness of cognitive training to enhance cognition in alcohol use disorder and improve treatment outcome.

Start: January 2020