Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in...
Alcohol DependenceTo determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care
Zonisamide for Heavy Drinkers With Bipolar Disorder
Alcohol Use DisordersBipolar DisorderThis is a randomized, double blind, placebo controlled trial of the medication zonisamide for the purpose of reducing heavy drinking and drinking, as well as reducing mood symptoms, in bipolar subjects that drink excessively and heavily. Hypotheses: (Primary aims); Add-on zonisamide compared to placebo will result in: significant reduction in heavy drinking days, drinks per week and per drinking day, and significantly greater increase in abstinent days, ii) greater rates of abstinence and abstinence to heavy drinking, greater reduction in biomarkers of heavy alcohol use such as gamma-glutamyl transferase (GGT), and greater reduction in alcohol urge or "craving", Significant reduction in prevalent mood symptoms on the BRMS and BRMeS, CARS, HAMD, or no worsening of euthymic mood, and significant improvement on the Clinical Global Impressions Scale-Severity. (Secondary aims) Add-on zonisamide compared to placebo will result in significant reduction in weight (kilograms) and other secondary weight-related metabolic factors such as fasting glucose, lipid profile, and blood pressure. (Secondary aims) Add-on zonisamide compared to placebo will result in improved clinical global impression, overall functioning, quality of life, and reduced medical symptoms. 5.) (Exploratory Aims) To will examine interactions between genotype and medication on treatment response for allelic variation in genetic loci related to the major neurotransmitter and neurophysiologic pathways that are relevant to bipolar disorder, alcoholism, and zonisamide mechanism of action.
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
Alcohol DependenceAlcoholism4 moreAlcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.
Fluoxetine and Bupropion to Treat Patients With Depression and Alcoholism
DepressionAlcoholism1 moreWe will study patients with a current major depressive episode, comorbid alcoholism and a history of a past suicide attempt. All subjects with alcohol dependence will be evaluated for risk of alcohol withdrawal prior to randomization. The study will provide six months of antidepressant pharmacotherapy as well as psychotherapy focused on alcohol relapse prevention. Patients will also be encouraged to attend daily Alcoholics Anonymous meetings. The outcome measures will be: 1) occurrence of suicide events; 2) reduction of suicidal ideation; 3) reduction in neuropsychological measures of impulsivity.
W-SUDs for COVID-19
Substance Use DisordersAlcohol Use DisorderThe 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. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
Cerebral Hemodynamics With rTMS in Alcohol Dependence
Alcohol DependenceThe present study measures the cerebral hemodynamic indices of alcohol dependent patients and observe the relative changes in these parameters with rTMS application.
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department...
Alcohol DependenceAlcohol Use DisorderOur 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).
Adaptive Interventions for Problem Drinkers
Alcohol-Related DisordersAlcohol Use Disorders3 moreThe purpose of this study is to understand how certain interventions help people reduce or quit their drinking and how certain interventions may help best at certain points in time in the change process.
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects...
Alcohol Use DisorderThis study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
The Effects of Oxytocin on Startle Hyperreactivity in Patients With AUD and PTSD
Stress DisordersPost-Traumatic1 moreThis study will investigate the effects of oxytocin on alcohol-related behaviors, social abilities, and physiological startle responses in healthy individuals and patients with posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) using a randomized, placebo-controlled, dose-tiered, between-subject study design. Specifically, the investigators will determine if intranasal administration of a single dose of the pro-social neuropeptide oxytocin decreases alcohol-related approach bias and cravings, enhances social abilities, and decreases physiological hyperactivity. The investigators will also determine the optimal dose to achieve these effects and will explore psychosocial predictors of responses to oxytocin. The proposed work has the potential to yield a novel pharmacological treatment for AUD and PTSD, both leading causes of disability in the US Military for which currently available treatments are inadequate.