122 Clinical Trials for Various Conditions
The traditional paradigm that relies upon training physicians and nurses or uses on-site interventionists to perform screening, brief intervention, and referral to treatment (SBIRT) for alcohol has proven unsustainable in most clinical settings. The Remote Brief Intervention and Referral to Treatment (R-BIRT) for alcohol is an innovative telehealth service model with potential to improve public health through evidence based counseling for patients who exceed the NIAAA low risk drinking limits or have evidence of an Alcohol Use Disorder with professional and self-help treatment. For those that are appropriate, the R-BIRT service will provide facilitated referrals to specialized alcohol abuse treatment. The service model is being studied in the emergency department (ED) setting to demonstrate its utility in a medical setting with a very high prevalence of risky alcohol use and Alcohol Use Disorders; however, the model is relevant and will be accessible to a broad array of healthcare settings, including primary care practices. Our new model, the R-BIRT, challenges the prevailing paradigm and offers the promise of not only clinical efficacy but increased cost effectiveness as well.
This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from other NIAAA protocols; (2) to provide a common set of descriptive information that will be available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before requiring patients to consent to evaluation for participation in research studies. Information collected will include such items as psychiatric diagnoses, presence or absence of brain, liver or other organ damage, history of the amount of past alcohol consumption, other substance use and family history of alcoholism. This information will allow investigators to determine for which, if any, NIAAA research studies a subject is eligible. In order to avoid requiring intoxicated subjects to consent for procedures such as HIV testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will obtain consent from all alcoholic subjects in two phases, using two separate consent forms. The first consent form will express the subject's desire to be admitted to the NIAAA inpatient unit for the purpose of treatment for alcoholism and will authorize only medical evaluation and treatment for alcoholism and associated problems. After an alcoholic subject has been admitted to the inpatient unit and is judged to be no longer intoxicated or suffering from acute alcohol withdrawal he or she will be presented with the second consent which will describe the evaluation for participation in other NIAAA research studies. Non-alcoholic, healthy controls will sign only one consent form describing the data to be collected and evaluation for participation in other NIAAA research studies.
The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.
The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.
The purpose of this study is to understand social contexts and alcohol use. We hope to learn how being around peers affects alcohol consumption in young adults. About 250 young adults who drink alcohol frequently will take part in the study. This research is being funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Participation involves one in-person screening session with a same-sex platonic friend. Then participants will complete four in-person laboratory sessions where they will drink beverages containing alcohol or no alcohol. After completion of the laboratory sessions, participants will complete smartphone surveys for 28 days. Lastly, they will complete follow-up surveys 6 months and 12 months post-study enrollment.
In the last decade, there has been an explosion of new knowledge of the neuroscientific basis of alcohol-seeking behavior. Briefly, medications that modulate mesolimbic dopamine pathways by facilitating gamma amino butyric function and inhibiting the action of excitatory amino acids should reliably diminish alcohol's rewarding effects. Topiramate (a sulfamate-substituted fructo-pyranose derivative) has these characteristics. In support of this concept, we have shown in a phase-II-type medications clinical trial that topiramate is significantly superior to placebo at improving drinking outcomes and decreasing craving among (N = 150) alcohol-dependent individuals. Using the carefully controlled environment of the human laboratory, we are submitting a revised application containing a set of systematic studies to assess directly the mechanistic neuropharmacological processes that are associated with topiramate's anti-drinking effects. This will provide a more comprehensive understanding of the neurobiology of alcohol-seeking behavior and aid in the development of even more effective compounds for the treatment of alcohol dependence. Thus, the specific aims of the project are to: 1) determine the dose-relationship of acute effects of topiramate to reduce alcohol effects related to its abuse and addiction potential. We hypothesize that topiramate will reduce alcohol-induced craving, reward, and euphoria; 2) determine whether chronic treatment with an acutely effective dose of topiramate produces substantial reductions in alcohol-related cue-induced craving, thereby decreasing the potential for treatment relapse. We hypothesize that chronic topiramate administration will desensitize (reduce) alcohol craving produced by alcohol-related sensory cues; and 3) determine whether topiramate interactions with and without alcohol are associated with neurocognitive impairment. Clinical studies including ours have suggested that topiramate use may be associated with neurocognitive effects such as loss of concentration and memory impairment. In our own study, these effects were mild and not associated with reduced treatment compliance. Since alcohol's ability to produce neurocognitive impairment may be mediated through similar ionic mechanisms to that of topiramate, the proposed human laboratory setting affords us the unique opportunity to more clearly delineate topiramate's neurocognitive effects in both the presence and absence of alcohol. This study supports NIAAA's goal to develop effective medications for treating alcoholism and to understand the basic underpinnings of the disease.
The purpose of this study is to determine whether Integrated Cognitive Behavioral Therapy or Twelve Step Facilitation Therapy is most effective for treatment of dually diagnosed veterans with depressive and substance use disorders.
This study is being done to determine if citalopram is safe and effective in the treatment of alcohol dependence. A second purpose is to evaluate whether alcohol dependent individuals who differ in a specific genetic marker respond differently to citalopram. Citalopram is a drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression. It belongs to a category of medications called selective serotonin re-uptake inhibitors or SSRIs. The U.S. FDA has not approved citalopram for the treatment of alcohol dependence. Therefore, it is being used "off-label" in this study.
The study examines the relative efficacy of two active aftercare interventions (i.e., face-to-face , brief phone) with no-active aftercare for adolescents who completed outpatient treatment for alcohol use disorders(AUD)
The purpose of this study is to determine if Divalproex Sodium can be used to Treat and Prevent Depression in Patients with Bipolar Disorder who have Comorbid Alcohol Dependence/Abuse.
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.
This is a phase 4, open-label, feasibility study of extended release naltrexone (Vivitrol, Alkermes Pharmaceutical) and case management for treatment of alcohol use disorders in the ED. Excess alcohol use is a major cause of morbidity and mortality and contributes to a large number of emergency department (ED) visits. The rate of alcohol-related ED visits is increasing, and 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. 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. ED patients with alcohol use disorders frequently 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. Regardless of comorbidity, limited access to substance use and mental health services is a significant barrier to receiving treatment, and large disparities exist in access based on income level. Facilitated referrals, where a healthcare worker communicates with the patient and service providers and assists the patient with obtaining follow up, have been used effectively to improve access to specialty care after ED discharge. Case managers are familiar with community treatment resources and are well versed in providing facilitated referrals. The primary hypothesis is that implementing this multimodal treatment will be feasible in an ED setting and will reduce alcohol use. Feasibility measures (recruitment, retention, continuation of treatment after the trial) are the primary outcomes. The intent of the intervention is to change drinking behavior in a way that benefits participants' health and quality of life. As such, we will conduct a limited efficacy assessment. Treatment efficacy will be assessed by comparing alcohol consumption, quality of life, and life consequences related to alcohol use before and after the intervention. The primary efficacy outcome is change in total alcohol consumption measured by a 2 week timeline follow back. Change from baseline will be assessed after the 3 month intervention period, and at the conclusion of the study follow up period for all outcomes.
The purpose of this study is to determine the effects of treatment with carisbamate compared to treatment with placebo, on alcohol-induced stimulant and subjective effects in non-treatment seeking alcohol-dependent human volunteers.
The purpose of this study is to determine if citicoline, as an add-on therapy, will help reduce alcohol use in outpatients with alcohol dependence.
The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
The primary efficacy endpoint examines the hypothesis that ABT-436 will decrease the weekly percentage of heavy drinking days during Study Weeks 2 through 12 (Days 8-84) as compared to placebo. A "heavy drinking day" is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
The purpose of this study is to determine whether varenicline is effective in the treatment of alcohol dependence in smokers.
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
The primary objective of this study is to assess the efficacy of varenicline in reducing the proportion of heavy drinking days during the last 8 weeks of treatment in subjects with alcohol dependence confirmed by Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria and who frequently consume 10 or more drinks per drinking day for men and 8 or more drinks for women (designated as "very heavy" drinkers).
A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.
This is a double-blind, placebo-controlled, parallel group design study with 4 treatment groups; levetiracetam, zonisamide, topiramate, and placebo control. Subjects will receive study medications for 14 weeks. Potential subjects will be initially screened for interest in study participation and alcohol consumption level to determine basic eligibility by telephone, or in person. Individuals who meet telephone screening criteria will be scheduled for a clinic appointment to obtain informed consent and conduct screening assessments. Subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) in the two weeks prior to screening will be excluded. Subjects meeting screening criteria will be scheduled for a second randomization visit. During this visit baseline assessments will be obtained. Eligible subjects will then be randomized to a treatment group and will be provided with the first week's study medications. The goal is to directly compare the efficacy and tolerability of two novel anticonvulsants, zonisamide and levetiracetam, with placebo, and using topiramate, which has extensive evidence supporting its efficacy in alcoholism, as a positive control group. We believe that this will be the first direct comparison of these agents in alcoholism, and the results will provide information on the efficacy and safety of the medications.
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
This is a pilot study designed to examine the potential efficacy and tolerability of zonisamide compared to placebo for the treatment of alcohol dependence.
The purpose of this study is determine whether the use of topiramate is effective in the treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.
The purpose of this study is to determine whether quetiapine fumarate extended release is effective in the treatment of alcohol dependence in very heavy drinkers.
This is a study about treatment for people who suffer from both major depression and alcohol abuse or dependence. The study will examine whether the addition of acamprosate to escitalopram and behavioral interventions will improve outcomes for this population.
We 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.
The purpose of this study is to determine if having an alcohol use disorder affects recovery from depression, and also whether recovery from depression in patients who have alcohol use disorders is also accompanied by improvement in the alcohol use disorder.
The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.
The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.