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Alcoholism clinical trials

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NCT ID: NCT02205879 Completed - Alcoholism Clinical Trials

Pregabalin for Alcohol Dependence

Start date: January 2013
Phase: Phase 4
Study type: Interventional

The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity

NCT ID: NCT02197598 Completed - Alcohol Dependence Clinical Trials

Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use

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

The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.

NCT ID: NCT02196142 Completed - Clinical trials for Psychological Stress

Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence

CAR-Bern 2013
Start date: November 2014
Phase: Phase 3
Study type: Interventional

To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects. Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication. Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.

NCT ID: NCT02193256 Completed - Cigarette Smoking Clinical Trials

Varenicline + Prazosin for Heavy Drinking Smokers

Start date: July 2014
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to examine the effect of varenicline and prazosin on smoking, drinking, and sleep among cigarette smokers who report heavy alcohol use. Varenicline is an FDA approved smoking cessation medication. Some smokers report sleep problems when taking varenicline. This study will test whether using prazosin, which is an FDA-approved blood pressure medication, in combination with varenicline reduces sleep problems that can be associated with using varenicline for smoking cessation. In addition, the study will examine the combined effects of these medications on smoking and drinking. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone prior to the 3-day practice quit attempt. Hypothesis: Varenicline plus prazosin will result in lower rates of vivid dreams and insomnia symptoms/sleep discontinuity than varenicline alone during the 3-day practice quit attempt.

NCT ID: NCT02193204 Completed - Alcohol Dependence Clinical Trials

Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to examine potential stress and immune systems adaptations underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social drinkers (SDs) with and without high levels of depressive symptomatology (+dep / - dep). Using the investigators experimentally validated guided imagery procedure, the investigators propose to examine the response of brain stress and immune systems to personalized guided stressful imagery using subjective, physiological and neurobiological assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without depressive symptomatology.

NCT ID: NCT02188043 Completed - Clinical trials for Alcohol Use Disorder

Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals

Relay
Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients at a general hospital to start specialized alcohol treatment in order to assess i) efficacy, ii) cost-effectiveness and iii) overall societal cost impacts. The effect of the Relay Model will be investigated in a single-blind pragmatic randomised controlled trial in which the control group consists of patients referred to treatment by usual procedures.

NCT ID: NCT02187224 Completed - Alcohol Dependence Clinical Trials

Progesterone Effect on Individuals Diagnoses With AD and PTSD.

Start date: September 1, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days. One goal of this research study is to test if progesterone is more effective than placebo in reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm among men and women with AD and PTSD. We hypothesize that progesterone in comparison to placebo will significantly reduce craving for alcohol in response to trauma cues alone and in combination with alcohol cues in individuals with AD and PTSD. A second goal is to examine if there are gender differences in progesterone effects on stress and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress and craving will be stronger in women than in men. Participants will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.

NCT ID: NCT02187211 Completed - Alcohol Dependence Clinical Trials

Minocycline's Effects on Alcohol Responses in Humans

Start date: July 1, 2015
Phase: Phase 1
Study type: Interventional

This is a double-blind, placebo-controlled, outpatient study with a between-groups design. Sixty male and female heavy social drinkers will be randomly assigned to minocycline (200 or 400 mg/day) or placebo for 10 days. In the first 7 days of treatment, subjects will have 3 outpatient visits for medication administration, dispensing of take-home doses and monitoring of any adverse effects from study medications. On days 8 and 10 of treatment, subjects will have 2 laboratory sessions where alcohol or placebo will be administered intravenously using a clamp procedure. Alcohol administration will use a breath alcohol concentration (BrAc) method, targeting 100 mg %. The alcohol clamp procedure will allow collection of multiple outcome measures including subjective, motor, cognitive measurement and plasma cytokine levels.

NCT ID: NCT02185612 Completed - Depression Clinical Trials

The EARN-Health Trial of Financial Savings and Health

EARN-Health
Start date: October 2016
Phase: N/A
Study type: Interventional

The current literature in social epidemiology and public health suggests that low financial savings has an unsurprising negative relationship with subjective well-being, and increases the odds of making visits to a healthcare provider, receiving a chronic disease diagnosis, and experiencing medical disability. Earn.org is a community-based non-profit based in San Francisco with a mission to help low-income workers build lifelong savings habits and financial capability. The organization is one of the largest providers of "goal-based savings accounts" or "matched savings accounts" in the US. The investigators propose to conduct a randomized controlled trial to determine the health effects of Earn's savings program. Through this trial, the investigators will test three principal hypotheses: (1) Participants in the Earn account, as compared to a control group, are hypothesized to demonstrate improved scores on mental health scales assessing depression and anxiety. (2) Participants in the Earn account, as compared to a control group, are hypothesized to experience lower odds of harmful behaviors associated with stress, specifically tobacco and alcohol abuse. The investigators hypothesize that the effect on behaviors will be of smaller effect size, and more delayed, than the effect on mental health outcomes, judging from similar effects observed in the micro-credit literature. (3) The mediating variables between Earn account participation and beneficial health outcomes will include increased optimism and internal locus of control.

NCT ID: NCT02181569 Completed - Alcoholism Clinical Trials

Sleep Disturbance and Relapse in Individuals With Alcohol Dependence: An Exploratory Mixed Methods Study

Start date: July 10, 2014
Phase:
Study type: Observational

Despite research establishing the relationship between sleep disturbances and alcohol use, there is no clear understanding or model for what occurs once individuals who seek inpatient alcoholism treatment are discharged from rehabilitation facilities and attempt to integrate back into their homes and communities. The purpose of this investigation will be to characterize sleep patterns, perceptions, and beliefs throughout the process of alcohol rehabilitation. The misuse of alcohol is a global public health concern that compromises both individual and societal wellbeing, resulting in an estimated 2.5 million deaths annually. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) distinguishes alcoholism by craving, loss of control, physical dependence, and tolerance (NIAAA, Alcohol Use Disorders). The relationship between alcohol use and sleep disturbances is complex and bidirectional, but sleep disturbances are common among alcoholics during phases of drinking, withdrawal, and abstinence. Outcome expectancies, behavioral capability, and self-efficacy beliefs are central constructs in the Social Cognitive Theory and will be measured directly in this study using both quantitative and qualitative methods. A mixed methods approach will be used to study the following aims: a) to assess individuals' perceptions of and experiences with sleep during alcohol rehabilitation, b) to describe sleep patterns, perceptions, and beliefs among alcohol-dependent individuals throughout the transition from a clinical research facility providing rehabilitation treatment back to the community, c) to assess whether sleep-related beliefs and/or behavior of individuals are predictive of sleep quality or relapse to drinking, and d) to assess whether sleep quality predicts relapse. Adult research participants admitted to the inpatient behavioral health unit and enrolled on to the NIAAA intramural study NCT 0010693: Assessment and Treatment of People with Alcohol Drinking Problems will be recruited for participation in this study (n=215). Sleep quality and duration will be quantitatively assessed approximately one week prior to discharge from the inpatient facility and again 4-6 weeks post-discharge. A sub-set of participants will be asked to wear actiwatches (accelerometers) to provide objective data on sleep throughout the transition from inpatient to outpatient. In addition to quantitative measures, qualitative semi-structured interviews will be conducted with a subset of 25 participants (to reach 25 completed cases) within a week of the scheduled discharge date and again four to six weeks post-discharge to assess perceptions of sleep during recovery. The proposed study will fill a gap in the literature by characterizing sleep throughout the rehabilitation process and ongoing maintenance of abstinence.