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48 active trials for Alcohol Abuse

Aripiprazole for Bipolar Disorder and Alcohol Use Disorder

The investigators will conduct a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric symptoms (mania/hypomania and depression) and predictors of response will be assessed. Participants with ? 1 drinking day at week 12 will be enrolled in a 4-week extension phase with an upward titration to 30 mg/day for those in the active treatment group. The placebo group will remain on placebo. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder and AUD, development of active suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe or life-threatening medical condition, involuntary psychiatric hospitalization or incarceration, significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or amphetamine-positive urine drug screen during the study.

Start: November 2016

Early Detection of Alcoholic Liver Disease

This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis. The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy). Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors. The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.

Start: November 2021

Theta Burst Stimulation as a Tool to Decrease Drinking in Treatment-seeking Alcohol Users

There is growing interest in the utilization of transcranial magnetic stimulation (TMS) as a novel, non-pharmacologic approach to decreasing alcohol use among treatment-seeking individuals with Alcohol Use Disorder (AUD). The results of this study will be used to determine which of the 2 proposed TMS strategies has a larger effect on drinking behavior (% days abstinent, % heavy drinking days) as well as alcohol cue-reactivity in a 4 month period. These data will pave the way for TMS to be used as an innovative, new treatment option for individuals with AUD.

Start: May 2020

Effect of Theta Burst Stimulation on Alcohol Cue Reactivity

Alcohol Use Disorder (AUD) is prevalent, devastating, and difficult to treat. The intransigence of AUD is readily apparent in the Trauma Unit of Wake Forest University Baptist Hospital, wherein 23% of trauma related admissions are associated with alcohol - higher than the national average of 16%. Of these trauma related admissions, over 70% are estimated to have AUD and 41% will be likely be admitted to the trauma unit again within 5 years. While Dr. Veach (Co-Investigator) and her team in the Department of Surgery have demonstrated that a brief counseling intervention on the inpatient trauma unit can decrease morbidity and recidivism, the rates of AUD and relapse to drinking among these individuals remains very high. With a growing knowledge of the neural circuits that contribute to relapse in AUD, there is an emerging interest in developing a novel, neural-circuit specific therapeutic tool to enhance AUD treatment outcomes. This will be achieved through a double-blind, sham-controlled cohort study in 48 heavy alcohol drinkers with a history of alcohol-related injury. The brain reactivity to alcohol cues (Incentive Salience) and cognitive performance in the presence of an alcoholic beverage cue (Cognitive Control) will be measured immediately before and after participants receive real or sham intermittent theta burst stimulation (iTBS- a potentiating form of transcranial magnetic stimulation (TMS)) to the dorsolateral prefrontal cortex (dlPFC iTBS). The goals of this pilot study are to quantify the acute effect of a single session of real or sham dlPFC iTBS on brain response to alcohol cues (Aim 1) and cognitive flexibility in the presence of an alcohol cue (Aim 2) among risky drinkers (target engagement ).

Start: August 2020

Personal Values and Mandated Students

This study aims to examine the efficacy of an enhanced alcohol intervention among individuals who are mandated to complete an alcohol education activity as part of a university sanction.

Start: March 2018

Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption. Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use. Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation. Participants will be screened with: Psychometric Scales Medical history Physical exam Urine tests and breathalyzer After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo: Psychometric Scales Venous blood sample (BDNF/proBDNF levels) Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected. Treatment includes: tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area. BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. Repeat of screening tests and questionnaires Urine toxicological screen and breathalyzer

Start: July 2021

Sex Differences in Risk for Alcohol Abuse

This study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

Start: November 2019

Using Counter Attitudinal Advocacy to Change Drinking Behavior

High volume drinking by young adults has proven resistant to change, so new approaches are needed. We adapt a theory-based attitude change strategy for use in alcohol prevention. This research tests the impact of brief writing and advocacy activities on subsequent drinking and negative consequences.

Start: November 2019

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

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)

Start: May 2019

The Australian Parental Supply of Alcohol Longitudinal Study (APSALS)

Parents can positively influence their children's alcohol use. One strategy they use is to provide their children with alcohol, believing it is the best way to teach their children how to drink responsibly. The impact of parental supply is not well understood and may be unintentionally harmful. This study will research the consequences of parental supply within the broader context of parent, child and peer relationships. It will help to determine how parental supply influences the different patterns of adolescent alcohol consumption over time, providing essential information to help parents prevent alcohol misuse in their children. Parents can play a pivotal role in prevention of alcohol misuse, but at present we don't know exactly how.

Start: March 2010

Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to: to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature. Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

Start: September 2021

Continuing Care Following Drug Abuse Treatment: Linkage With Primary Care

This component of a larger Center of Research Excellence Grant improves treatment for drug abuse by developing effective linkages between specialty drug treatment and primary health care.

Start: March 2011

CARES: A Mobile Health Program for Alcohol Risk Reduction

In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult community college students. The app is designed to reduce risky drinking behaviors and improve user safety. In Phase 2 the app ("CARES") will be tested with 200 adult community college students who drink alcohol. Participants will be randomly assigned to the "CARES" app or an alcohol education control condition and will use the app for 12 weeks. Six month outcomes will assess changes in drinking related behaviors.

Start: August 2018

A Smartphone Based Intervention for the Prevention of Relapse in Alcohol Dependence

The rate of relapse following an inpatient alcohol rehabilitation program has been around 50% for a number of years. Offered treatments mainly focus on conscious and controllable aspects of behaviour, but research has found that much of the craving in addiction is guided by automatic processes, which are for a large part unconscious and poorly controlled by the individual. One way to influence these automatic processes is by applying cognitive bias modification, a cognitive-behavioural intervention that can be applied by a computer application. In alcohol addition, a common cognitive bias is the Alcohol-Approach bias. The Anti-Alcohol Training is a form of cognitive bias modification that was developed to reduce this approach bias and it has been shown to reduce the rates of relapse by 4-8%. A drawback of the training is that patients do not continue this at home after discharge. One way to increase accessibility is to offer the training in an app-game form. In this study the investigators have developed a smartphone based training app that allows patients to more easily use the Anti-Alcohol training at home after discharge. The study aims to assess whether use of the app further reduces the alcohol bias and whether it can reduce yearly relapse rates.

Start: May 2019

Tobacco Cessation Among Smokers Under Alcohol and/or Cannabis Treatment

Aims: To identify the predictors associated with smoking cessation in smokers under treatment for alcohol and/or cannabis treated in drug treatment centers (DTC). Methodology: Mixed methods project with qualitative and quantitative designs (three studies). Study I discussion groups: of clinical professionals of DTC to explore the barriers/facilitators of these smokers in quitting and the interventions carried out. Study II Prospective cohort of smokers in alcohol and/or cannabis treatment that will be followed-up for 12 months. Sample size: difference in incidence (exposed to cessation interventions versus non-exposed = 12 per 100 years), ? = 0.05, ? = 0.10, losses = 20% (n = 726). Dependent variables: self-reported and verified tobacco consumption abstinence, quit attempts, motivation, and self-efficacy. Independent variables: age, sex, the substance under treatment. Analysis: incidence, relative risk and simple and multiple logistic regression models (odds ratio and confidence interval, CI, 95%) of quitting. Study III discussion groups: with smokers under alcohol and/or cannabis treatment selected according to their typology. Analysis: of thematic content and triangulation qualitative and quantitative results. Expected results: Characterization of variables that influence tobacco cessation, to improve the design of interventions.

Start: October 2020

Mindfulness for Alcohol Abusing Offenders

Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Thus, there is a critical need for more effective interventions that could help disrupt this insidious cycle of alcohol abuse, criminal behavior, and incarceration. This project will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.

Start: July 2018

e-Health Coping Skills Training for Women Whose Partner Has a Drinking Problem

This study evaluates web-based interventions to help women cope with the stress arising from living with a problem-drinking partner

Start: October 2019

Factors Predicting Outcome in Group Treatment of Alcohol Use Disorders (AUDs)

Harmful alcohol use is a global risk factor for disease, injuries and death. Research on treatment of Alcohol use disorders (AUDs) indicates that different treatment modalities are equally effective, but also that a large group of patients do not change their drinking pattern despite being in treatment. It is assumed that it is not random who benefits from treatment. Thirty to forty percent of outcome variance in treatment is probably explained by patient factors, and we need more knowledge on how different patient factors moderate treatment effects. Further, clinicians also need more knowledge about selecting patients to different therapies. The present study will investigate how patient factors predict outcome in group treatment of AUDs, and what predicts positive treatment outcomes over time. The study is designed as a quasi-experimental, multi-centre, follow-up study. Patients will be included from Vestfold Hospital Trust, Borgestadklinikken, Blue Cross Clinic, Behandlingssenteret Eina, Blue Cross Clinic and A-senteret, Oslo, Church City Mission. The Project will provide more knowledge about patients seeking treatment for AUDs, and specifically how patient factors predict outcome in group treatment. These results will in turn lead to better selection of treatment modalities, and patients will receive a more effective treatment earlier on. Main aims: 1) How do patient factors predict outcome in group treatment of alcohol use disorders (AUDs)? 2) Do positive treatment outcomes last over time? Specifically, do the following factors: a) psychiatric comorbidity b) severity of alcohol use pre-treatment c) personality disorders and d) cognitive impairments predict 1) completion of group treatment and 2) positive outcome after 1 year. As an additional aim, we will investigate if the Montreal Cognitive Assessment test (MoCa) is feasible as a brief screening instrument for mild cognitive impairments for AUD patients.

Start: February 2021

Talk Therapy by Phone to Promote Treatment for Alcohol Problems

A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.

Start: March 2019

Effect of Alcohol and Drugs of Abuse on Immune Function in Critically Ill Patients With Respiratory Failure

This study plans to learn more about people who are sick in the hospital with a lung infection, or respiratory failure. Respiratory failure, or severe lung failure, is a life-threatening disease. When it happens, the lungs have trouble carrying out their normal function of getting oxygen into the blood, and removing carbon dioxide from the body. Investigators are conducting this study to see what drinking too much alcohol, using tobacco products, or using drugs (both legal and illegal) may do to lung infections and respiratory failure. Subjects are asked to be in this research study because they are thought to have a lung infection and may also have respiratory failure. Alcohol, tobacco, and drug use have been linked to lung infections, respiratory failure, and even death, but the reasons for this aren't known. People who use unhealthy amounts of alcohol, tobacco, and or drugs may be more at risk for lung infections, and for severe complications due to lung infection. Subject participation is important whether or not you use alcohol and or drugs.

Start: November 2014