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Alcoholism clinical trials

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NCT ID: NCT03970109 Terminated - Clinical trials for Alcohol Use Disorder

HLAB-002 of ANS-6637 for Alcohol Use Disorder

Start date: October 8, 2019
Phase: Phase 2
Study type: Interventional

Primary: The primary objective of this study was to evaluate the effects of 2 different doses of ANS-6637, 200 mg (given as 2 x 100 mg tablets) and 600 mg (given as 2 x 300 mg tablets) once a day, and matched placebo, on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 1 week of daily dosing among subjects with moderate to severe alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). Secondary: Secondary objectives included evaluation of ANS-6637 200 mg, ANS-6637 600 mg, and matched placebo on reduction of alcohol consumption, alcohol craving, cigarette smoking (among smokers) and nicotine use (among nicotine users), mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability throughout the last 4 weeks of the treatment phase of the study.

NCT ID: NCT03966885 Terminated - Depression Clinical Trials

Zambia Common Elements Treatment Approach Pilot Study

ZCAP
Start date: June 24, 2019
Phase: N/A
Study type: Interventional

This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.

NCT ID: NCT03897062 Terminated - Insomnia Clinical Trials

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse. This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.

NCT ID: NCT03876132 Terminated - Alcohol Abuse Clinical Trials

Perception of the Risks of Alcohol and Individual Vulnerabilities in Young Adults

DEPREV
Start date: November 14, 2019
Phase:
Study type: Observational

Alcohol use is the second leading cause of preventable death after smoking. The Evin law was built in 1991 with the goal of reducing exposure to alcohol marketing among the youngest. But this law is currently extremely weakened, and in a press release of February 26, 2018, the French Society of Alcoology is alarmed by these developments. Studies focusing on the impact of alcohol marketing focus largely on young adolescents, and the links between exposure to marketing and the initiation of alcohol. But beyond these links, there has been little work on the impact of alcohol marketing in vulnerable subjects with regular alcohol consumption. Consumption of alcohol is one of the first causes of hospitalization in France (Paille and Reynaud, 2015), the damage is often restricted to notions of dependency risks, but they can appear as soon as consumptions of 1 US / d (Guerin and Laplanche, 2013) and they mainly concern 45-64 year olds. To our knowledge, there are no studies on the impact of alcohol marketing conducted on regular alcohol users, depending on how they use alcohol (use, or use disorders). mild, moderate or severe) in patients enrolled in primary care and specialized addiction care.

NCT ID: NCT03860753 Terminated - Clinical trials for Alcohol Use Disorder

Effects of Pioglitazone on Stress Reactivity and Alcohol Craving (Pilot)

Start date: March 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the effect of pioglitazone on stress- and alcohol-related measures in treatment-seeking individuals with alcohol use disorder (AUD) and elevated levels of stress and anxiety.

NCT ID: NCT03854942 Terminated - Alcohol Addiction Clinical Trials

Study of the Opioid Modulation of the Effect of Alcohol on the Dopaminergic Reward System

Start date: August 30, 2011
Phase: Phase 1
Study type: Interventional

About 10% of the calculable loss of health and quality of life in industrial countries can be attributed to excessive alcohol consumption. Behavioural pharmacological, genetic and clinical studies on alcohol dependence suggest a multifactorial model for the development of the disease, which ascribes an important role in the development of the disease to genetic variance, educational style and continued substance use. Animal and human experimental studies suggest that continued alcohol consumption leads to a pathological activation of the mesolimbic reward system. In the presented study, the modification of the alcohol-mediated activation of the mesolimbic reward system by the administration of the opiate antagonist naltrexone will be investigated in a human in vivo model. The aim is to gain important insights for the further development of pharmacological treatment options for alcohol dependence. Further development of pharmacological treatment options for alcohol dependence seems urgently necessary in order to slow down the high tendency to relapse and prolong the short abstinence period.

NCT ID: NCT03852628 Terminated - Clinical trials for Post Traumatic Stress Disorder

Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD

Start date: May 20, 2019
Phase: Phase 2
Study type: Interventional

Objective: Evaluate the efficacy and physiological effects of sublingual buprenorphine (SL-BUP; Subutex) combined with extended-release injectable naltrexone (XR-NTX; Vivitrol) in the treatment alcohol use disorder of comorbid (AUD) and post-traumatic stress disorder (PTSD)

NCT ID: NCT03736343 Terminated - Clinical trials for Alcohol Use Disorder (AUD)

Impulsivity and Alcohol Response

IDEA
Start date: May 1, 2019
Phase: Early Phase 1
Study type: Interventional

Impulsivity, a well-known risk factor predicting negative outcomes, refers broadly to a proclivity towards rapid action with a suboptimal regard for future consequences. Importantly, impulsivity is a multidimensional construct incorporating generalized and behavioral facets. However, underlying mechanisms linking facets of impulsivity to high-risk drinking remain uncertain. Such mechanisms, if uncovered, may be more appropriate intervention targets than impulsivity directly. Similar to impulsivity, subjective response to alcohol (SR), or individual differences in sensitivity to the pharmacologic effects of alcohol, is an established risk factor for alcohol use disorder. Specifically, experiencing heightened rewarding stimulation and dampened aversive sedation from alcohol are related to high-risk drinking. Theory and recent findings indicate SR and impulsivity may be related, suggesting SR may be a mechanism linking facets of impulsivity to high-risk drinking. However, findings linking impulsivity to SR were all from secondary data analyses and most studies reported on only a single measure of impulsivity. For these reasons, an original data collection using laboratory alcohol administration methods is needed to address which facets of impulsivity are related to SR among young adult drinkers and whether these effects manifest while blood alcohol concentrations are increasing or declining. This study will utilize a laboratory alcohol administration design to investigate whether distinct facets of impulsivity (i.e., generalized, choice, response) are related to subjective responses (i.e., stimulation and sedation) following alcohol administration.

NCT ID: NCT03648840 Terminated - Alcohol Abuse Clinical Trials

Human Alcohol Seeking Despite Aversion

Start date: April 4, 2018
Phase: N/A
Study type: Interventional

Prolonged alcohol use results in drinking despite resultant problems and adverse consequences. The investigators propose to test a laboratory model of human seeking despite aversion to use as an early marker of disease onset, and as a tool for study of its neural functional substrates, and identification of effective treatments.

NCT ID: NCT03645408 Terminated - Clinical trials for Alcohol Use Disorder

The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

Start date: May 2, 2019
Phase: Phase 1
Study type: Interventional

A double-blind, randomized, placebo-controlled, crossover design trial was used to test the effect of exenatide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this research was to determine whether exenatide has effects on alcohol consumption.