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Alcoholism clinical trials

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NCT ID: NCT02723383 Completed - Alcoholism Clinical Trials

Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

BACLOREA
Start date: June 27, 2016
Phase: Phase 3
Study type: Interventional

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients. Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day. Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.

NCT ID: NCT02705898 Completed - Alcohol Dependence Clinical Trials

Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women

Start date: September 2015
Phase: N/A
Study type: Interventional

Building on the large body of evidence for the effect of exercise in decreasing depressive symptoms and the few preliminary findings of its effect on craving and drinking outcomes, the purpose of this study is to develop a lifestyle physical activity (LPA) intervention that harnesses the technological advantages of the Fitbit tracker (plus its web and mobile platforms) for depressed women with alcohol use disorders (AUDs). The intervention will provide women with an acceptable, flexible and effective alternate coping strategy during early recovery, when relapse risk is highest. The overall objective of this work is to fully develop this LPA+Fitbit intervention, modify it based on initial piloting and feedback to ensure its feasibility and acceptability for depressed women with AUDs in early recovery, propose potential mechanisms of its effect, and to obtain preliminary data on its efficacy.

NCT ID: NCT02698215 Completed - Clinical trials for Alcohol Use Disorder

Combining Varenicline and Naltrexone for Smoking Cessation

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This study is a double-blind, randomized clinical trial using a two group medication design consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1 mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking daily smokers who want to quit smoking and reduce drinking.

NCT ID: NCT02691390 Completed - Alcohol Abuse Clinical Trials

Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder

Start date: July 1, 2016
Phase: Phase 1
Study type: Interventional

dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.

NCT ID: NCT02689674 Completed - Alcohol Dependence Clinical Trials

Adaptive Treatment for Alcohol Dependence

Start date: February 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and alcohol use over weeks 1-24. Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP). Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP). Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and alcohol use outcomes in each option. Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and alcohol use outcomes in each option. Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and alcohol use outcomes over weeks 1-24. Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group. Hypothesis 2: The predicted main effect on cocaine use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.

NCT ID: NCT02681406 Completed - Alcohol Abuse Clinical Trials

Smartphone Based Continuing Care for Alcohol

Start date: September 2014
Phase: N/A
Study type: Interventional

Investigators will recruit 280 alcohol dependent patients in treatment programs in the Philadelphia area to test the efficacy and cost efficiency of a smartphone based application for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC). Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6 months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.

NCT ID: NCT02679469 Completed - Alcohol Dependence Clinical Trials

A Single-center, Open-label, Single-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Nalmefene 10 mg Tablets in Healthy Japanese Male Subjects

Start date: February 2016
Phase: Phase 1
Study type: Interventional

The safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy Japanese male subjects will be evaluated.

NCT ID: NCT02675777 Completed - Clinical trials for Alcohol Use Disorder

Sustaining Patient-centered Alcohol-related Care

SPARC
Start date: February 2016
Phase: N/A
Study type: Interventional

Alcohol use is the third greatest cause of disability and death for US adults. Care for unhealthy alcohol use is lacking in most primary care settings. This project will implement two types of evidence-based care for unhealthy alcohol use in the 25 primary clinics of a regional health system—Group Health (GH). These include preventive care and treatment. Preventive care consists of alcohol screening, and for patients who screen positive, brief patient-centered counseling. Treatment for alcohol use disorders includes offering shared decision making and motivational counseling designed to enhance engagement in one or more treatment options: counseling, medications, and/or specialty treatment. During a pilot phase, the research team at Group Health Research Institute partnered with Group Health leaders and front line clinicians to design, pilot test, and iteratively refine an implementation strategy in 3 Group Health primary care clinics. Objective This study uses state-of-the-art implementation strategies to integrate evidence-based alcohol-related care into 22 primary care clinics (detailed below). This study is a pragmatic stepped-wedge quality improvement trial to evaluate its impact on: 1. The proportion of patients who have primary care visits who screen positive for unhealthy alcohol use and have documented annual brief alcohol counseling; 2. The proportion of patients who have primary care visits who have AUDs identified, and a) initiate and b) engage in care for AUDs. Secondary outcomes will include: 1. The proportion of patients who have primary care visits who have documented annual alcohol screening with the AUDIT-C; and 2. The proportion of patients who have primary care visits who screen positive for severe unhealthy alcohol use and have AUDs assessed and/or diagnosed;

NCT ID: NCT02674477 Completed - Clinical trials for Substance-related Disorders

Treatment Engagement With Technology-assisted Treatment

TETAT
Start date: February 29, 2016
Phase: N/A
Study type: Interventional

This research is being done to study whether using an Internet-based program, called the Therapeutic Education System (TES), would be helpful for the treatment of substance use and other psychiatric problems.

NCT ID: NCT02668250 Completed - Stroke Clinical Trials

Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality

OPTI-AGED
Start date: February 3, 2017
Phase: N/A
Study type: Interventional

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.