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Alcohol Dependence clinical trials

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NCT ID: NCT04280068 Terminated - HIV/AIDS Clinical Trials

Targeting Non-virally Suppressed Adults With Alcohol Use Disorder in HIV Primary Care

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The proposed pilot study is a randomized feasibility trial of technology-enhanced brief intervention for drinking reduction and antiretroviral therapy (ART) adherence in 60 non-virally suppressed HIV participants who meet criteria for DSM-5 Alcohol Use Disorder (AUD) in a Primary Care clinic. Study sample will be recruited from a large urban HIV primary care clinic at Montefiore Hospital where the investigators previously successfully enrolled, randomized and treated study participants The interventions consist of brief meetings to discuss drinking and ART adherence enhanced with daily self-monitoring through the use of a smartphone application that tracks drinking and other aspects of health. These meetings will be based on the Clinician's Guide, a brief intervention for heavy drinking in primary care settings advocated by the National Institute on Alcohol Abuse and Alcoholism. Participants will be assessed at baseline, 30, 60, 90 days, and 6 months after baseline. By the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the Clinician's Guide alone, and lowest among participants who receive the Clinician's Guide plus the smartphone application.

NCT ID: NCT03056365 Terminated - Alcohol Dependence Clinical Trials

Advanced Nurses vs. General Practitioners for the Management of Outpatient Alcohol Detox: a Safety and Cost Comparison

SAMBA
Start date: January 1, 2017
Phase: N/A
Study type: Interventional

The SAMBA study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a GP-based treatment on the other hand (standard-of-care group). In the advanced nurse (AN) group, nurses manage alcohol detox using a predefined protocol based on both the Cushman and CIWA-Ar scales. Depending on the Cushman and CIWA-Ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. In case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. In the GP group, GPs can manage patients as they wish.

NCT ID: NCT02881424 Terminated - Alcohol Dependence Clinical Trials

Study of Familiarity in Alcohol Dependence

FALCO
Start date: March 2015
Phase:
Study type: Observational

Background: Alcohol-dependence is a chronic disease with a high risk of relapse. The main therapeutic outcome relies on relapse prevention which seeks to identify high risk situations and individual's response to these situations especially the emotional response to social environment. Alcohol-dependence also induces cognitive impairments leading to social cognition impairments increasing the risk of relapse. Familiarity is a key process in social interactions: it induces the feeling of prior knowledge of a stimulus without remembering consciously its identity. Followed by a second process based on the contribution of contextual information (recollection) familiarity allows face recognition. Main aim: Study of familiarity for faces in alcohol-dependence Secondary objectives: Highlighting correlations between familiarity impairments and clinical outcomes

NCT ID: NCT02771925 Terminated - Alcohol Dependence Clinical Trials

Treatment for Alcohol Dependence With Gabapentin

TAG
Start date: June 2016
Phase: Phase 4
Study type: Interventional

Alcohol use disorders are present across medical specialties, with alcohol-related deaths particularly prevalent in the categories of injury, liver cirrhosis, cancer, cardiovascular disease, disorders of the peripheral nerves and of the central nervous system. Alcohol dependence, also referred to as alcohol use disorder, is a chronic, relapsing disorder marked by compulsive alcohol use, an inability to stop drinking despite harmful consequences, and the emergence of a withdrawal syndrome upon cessation of use. Early abstinence is associated with activation of brain stress systems in the extended amygdala. Clinically, protracted abstinence involves symptoms of craving, mood and sleep disturbance, all of which have been identified as risk factors for relapse. Nonetheless, implementation of alcohol-specific medications remains limited across most medical specialties. Medications for treating alcohol dependence primarily have been adjunctive interventions, and only three medications—disulfiram, naltrexone, and acamprosate—are approved for this indication by the United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was originally approved by the Food and Drug Administration in 1977 for use in spasticity associated with neurologic conditions, such as multiple sclerosis and spinal cord lesions. However, due to its pharmacologic properties it has also been investigated for the treatment of alcohol dependence. But in the clinical practice of study physicians, it was observed that most of the patients who were prescribed baclofen for alcohol dependence hit back to alcohol very soon despite being on the drug. Therefore there is a need to search for an alternative drug which could be beneficial for this population of patients. Gabapentin is Food and Drug Administration-approved for the management of epileptic seizures and neuropathic pain. It is believed to act by blocking a specific alpha-2d subunit of the voltage-gated calcium channel at selective presynaptic sites and, as a result, to indirectly modulate Gamma Butyric Acid neurotransmission. Pre-clinical findings indicate that gabapentin normalizes the stress-induced Gamma Butyric Acid activation in the amygdala that is associated with alcohol dependence, and provide an excellent pre-clinical rationale for evaluating gabapentin as a treatment for alcohol dependence. Earlier studies of gabapentin in alcohol dependent subjects, attempting to abstain following withdrawal support the safety and potential efficacy of gabapentin in alcohol dependent patients, but definitive conclusions were limited by either small sample size, methodological, or dosing issues.

NCT ID: NCT02472483 Terminated - Bipolar Disorder Clinical Trials

Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

TCC-MBCT
Start date: September 13, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.

NCT ID: NCT02195817 Terminated - Alcohol Dependence Clinical Trials

Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care

Start date: August 2014
Phase: Phase 4
Study type: Interventional

To 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

NCT ID: NCT01764685 Terminated - HIV Clinical Trials

Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+ individuals than in the general population. HD adversely affects health directly and reduces adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive impairment. Reduced drinking improves cognitive performance and adherence to ARTs. Medications approved in the United States to treat alcohol dependence have a small effect size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine, has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy drinkers. The investigators propose to conduct a randomized, parallel-groups, placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce or stop their drinking. There are three primary hypotheses for this feasibility and proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients will decrease the frequency of their HD more than placebo-treated patients. Second, based on scores from computerized neurocognitive assessments, the investigators hypothesize that topiramate and placebo groups will show similar performance on a battery of cognitive tests. Third, based on self-reported medication adherence, the investigators hypothesize that adherence to ARTs will be greater in the topiramate group than in the placebo group. These findings will provide preliminary data to support a more definitive trial of topiramate for the treatment of HD in HIV+ heavy drinkers.

NCT ID: NCT01638377 Terminated - Alcohol Dependence Clinical Trials

Pharmacotherapy for Alcohol Dependence in Convicted Drinking Drivers

Start date: August 2012
Phase: Phase 4
Study type: Interventional

This pilot study will explore the ways to link Ontario's remedial system for convicted drinking drivers to medical intervention, assess the receptiveness of the Back on Track client population to effective medical interventions, and assess the feasibility of a full-scale trial of pharmacotherapy for convicted drinking drivers.

NCT ID: NCT01408641 Terminated - Clinical trials for Alcohol Use Disorder

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Start date: September 2012
Phase: N/A
Study type: Interventional

Alcohol 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.

NCT ID: NCT01155869 Terminated - Alcohol Dependence Clinical Trials

Pilot Study of Depot NTX in Homeless Veterans

Start date: August 2010
Phase: Phase 4
Study type: Interventional

Almost 200,000 veterans are homeless each night, about one-quarter to one-third of homeless adults in the U.S. Half need treatment for a substance use disorder, usually alcohol dependence, but sobriety is often required to access alcohol treatment and housing services. A monthly injection of depot naltrexone is efficacious in reducing alcohol use, but it is expensive and restricted in many VA Medical Centers. Oral naltrexone is more available but seldom used because of adherence problems that limit effectiveness. This open-label pilot study would compare the effect of depot versus oral naltrexone to help twenty homeless, alcohol-dependent veterans decrease their drinking, achieve sobriety and qualify for housing services. This study's findings could expand access to effective medication-assisted alcohol treatment in the VA, and thus help homeless veterans with alcohol problems improve their drinking, housing status, and appropriate use of health services.