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Alcohol Drinking clinical trials

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NCT ID: NCT02905123 Completed - Alcohol Consumption Clinical Trials

Brief Internet Intervention for Hazardous Alcohol Use

Start date: September 2016
Phase: N/A
Study type: Interventional

Amazon's Mechanical Turk (MTurk) is an online platform that has become a popular means of recruiting participants with problem drinking, gambling, or even illicit drug use for the purposes of survey-based research. There is also the possibility that potential participants could be identified through MTurk for online longitudinal studies, including for brief intervention research. The potential to quickly and easily identify large numbers of participants through MTurk is important for research evaluating online interventions during the period that these interventions are being developed and refined. However, before proposing MTurk workers as a viable source for participants in online intervention trials, it is important to evaluate the feasibility of using MTurk for such a purpose. This pilot study proposes to test this feasibility by systematically replicating a trial of an extensively evaluated brief online intervention for hazardous alcohol use (CheckYourDrinking; CYD) and will attempt to recruit and follow-up participants for this replication using people recruited through MTurk. Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 3 months time. Those who are interested will be randomized to receive access to the Check Your Drinking screener (CYD condition) or to a no additional information condition (control condition). At three-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey. The primary hypothesis to be tested is that participants receiving access to the CYD intervention will report a greater level of reduction in number of drinks in a typical week between the baseline survey and three-month follow-up as compared to participants in the no information control condition.

NCT ID: NCT02904629 Completed - Pregnancy Clinical Trials

Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents

TPP
Start date: May 2016
Phase: N/A
Study type: Interventional

The objective of this research study is to evaluate a culturally tailored sexual and reproductive health intervention among American Indian (AI) youth. Specifically, the investigators aim to evaluate the impact of "Respecting the Circle of Life: Mind, Body and Spirit" on knowledge, attitude and behavioral outcomes associated with risk for unprotected sex, sexually transmitted infection (STI) and unintended pregnancy through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the RCL intervention effectively reduces risky sexual behavior among AI adolescents (11-19 years old), with long term goals of reducing teen pregnancy and incidence/prevalence of STIs. The evaluation will focus on well-established intermediate outcomes/risky sexual behaviors that predict long-term impact on teen pregnancy and STI incidence.

NCT ID: NCT02900352 Completed - Clinical trials for Alcohol Use Disorder

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

Z-Comp
Start date: October 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, placebo-controlled, double-blind, 16 week trial of the medication zonisamide for the treatment of heavy drinking alcoholic civilians.

NCT ID: NCT02897804 Completed - Clinical trials for Sexually Transmitted Diseases

Engineering an Online STI Prevention Program

Start date: August 2016
Phase: N/A
Study type: Interventional

The overall objective of the proposed research is to reduce the incidence of sexually transmitted infections (STIs) among college students. The investigators propose to accomplish this by using the innovative, engineering-inspired multiphase optimization strategy (MOST) to develop a highly effective, appealing, economical, and readily scalable internet-delivered behavioral intervention targeting the intersection of alcohol use and sexual risk behavior. The rate of STIs on college campuses is alarming: one in four college students is diagnosed with an STI at least once during their college experience. Sexual activity when drinking alcohol is highly prevalent among college students. Alcohol use is known to contribute to the sexual risk behaviors that are most responsible for the transmission of STIs, namely unprotected sex, contact with numerous partners, and "hook-ups" (casual sexual encounters). Few interventions have been developed that explicitly target the intersection of alcohol use and sexual risk behaviors, and none have been optimized. In order to reduce the incidence of STI transmission among this and other high-risk groups, a new approach is needed. MOST is a comprehensive methodological framework that brings the power of engineering principles to bear on optimization of behavioral interventions. MOST enables researchers to experimentally test the individual components in an intervention to determine their effectiveness, indicating which components need to be revised and re-tested. Given the high rates of alcohol use and sex among college students, the college setting provides an ideal opportunity for intervening on alcohol use and sexual risk behaviors. The proposed study will include a diverse population of college students on 4 campuses which will increase the generalizability of the findings. The specific aims are to (1) develop and pilot test an initial set of online intervention components targeting the link between alcohol use and sexual risk behaviors, (2) use the MOST approach to build an optimized preventive intervention, and (3) evaluate the effectiveness of the newly optimized preventive intervention using a fully powered randomized controlled trial (RCT). This work will result in a new, more potent behavioral intervention that will reduce the incidence of STIs among college students in the US, and will lay the groundwork for a new generation of highly effective STI prevention interventions aimed at other subpopulations at risk.

NCT ID: NCT02895984 Completed - Alcohol Abuse Clinical Trials

Reducing Hazardous Alcohol Use in Social Networks Using Targeted Intervention

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

Alcohol use is almost ubiquitous on college campuses and first-year students are at particularly high risk of alcohol-related harm when they first make the transition to college. Peers are important agents in socializing both healthy and unhealthy behaviors, but despite the clear role of peer behavior in the maintenance of college problem drinking, there have been no efforts to measure the effect of individual change on the reduction of alcohol-related risks in the broader student body. That is, despite the importance of social connections for inducing and maintaining alcohol use in youth, intervention approaches have not measured nor capitalized on the potential of social influences for changing this problem behavior. It is essential that we understand the indirect effects of individual interventions and the impact such interventions have on the social structure and social connections. The best way to evaluate such effects is to use a research design that experimentally manipulates drinking using the best available intervention and measures its effects on the social network and its members. The purpose of this research is to investigate whether using an established individual Brief Motivational Intervention (BMI) administered to a small number of influential network members embedded in a social network significantly reduces heavy drinking and alcohol consequences among close peers who do not receive any intervention. In addition, the investigators will investigate social influence mechanisms of this transmitted effect, investigate how specific types of network connections and relationships moderate the indirect intervention effect, and investigate the effects of the intervention on network position and structure. First-year students at Brown will be enrolled and assessed early in their fall 2016 academic semester. Heavy drinkers in each dormitory who are in the top quartile of betweenness centrality, a social network construct that reflects high connectivity and potential influence, will either receive BMI or serve as controls, according to their dormitory's intervention assignment. All participants will be assessed again 5 and 12 months after baseline to measure changes in behavior and in peer ties. The long-term objective of this research is to understand how peer influences function in social networks in order to leverage those mechanisms to reduce problematic alcohol use in heavy drinking populations.

NCT ID: NCT02888002 Completed - Clinical trials for Alcohol Use Disorder

Internet-based vs Face-to-face Treatment for Alcohol Dependence

IMS
Start date: December 1, 2015
Phase: N/A
Study type: Interventional

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

NCT ID: NCT02885311 Completed - Alcoholism Clinical Trials

Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.

NCT ID: NCT02881983 Completed - Clinical trials for Alcohol Use Disorder

Study of Mechanisms of Emotion Regulation in Alcohol-abstinent Patients

REAL
Start date: April 2014
Phase: N/A
Study type: Observational

Background: Difficulties in assigning and identifying emotional states, or to regulate the emotional costs are recognized as one of the major factors of relapse. This study aimed to evaluate the emotion regulation processes, in short term (STA, after 1month of withdrawal) and long-term alcohol abstinent individuals (LTA, at least six months of abstinence), compared to healthy control participants (C) in a positive and negative emotion induction protocol. Main aim: Evaluating the emotional regulation deficits assessed with physiological indicators (heart rate variability, electrodermal response, pupil diameter) and clinically in presentations of visual stimuli to emotional value (positive, negative, neutral) in alcohol use disorder's (AUD) patients with short and long term abstinent compared to a control group of healthy subjects. The investigators are particularly interested in the evolution of heart rate variability considered as a good marker of vulnerability to AUD. Secondary objectives: Studying the relationships between physiological measures and clinical variables such as behavioral indicators and self-reported assessment of cognitive and emotional skills among the three groups (STA, LTA and C).

NCT ID: NCT02881060 Completed - Clinical trials for Diabetes Mellitus, Type 1

The Late Effects of Ethanol Intake on the Glucose Response to Subcutaneous Glucagon in Type 1 Diabetes

ALCO1
Start date: August 2016
Phase: Phase 4
Study type: Interventional

Objective: Because many people with type 1 diabetes drink ethanol and because glucagon is used to treat mild hypoglycaemia, it is essential to determine whether ethanol will impair the effectiveness of glucagon to increase glucose, which may impair the effectiveness of the dual hormone treatment in preventing hypoglycaemia. The purpose of this study is to determine, whether ethanol influences the glucose response to subcutaneous glucagon during mild hypoglycaemia. The investigators hypothesize that prior evening ethanol consumption does not reduce the effect of a glucagon bolus to raise plasma glucose compared with no prior ethanol consumption. The study aims: 1. To determine the late effects of ethanol on the efficacy of subcutaneous glucagon to restore plasma glucose after an episode of mild hypoglycemia. 2. To determine the late effects of ethanol on the counter-regulatory hormones and hypoglycaemia awareness during mild hypoglycaemia A double-blinded placebo-controlled study will be conducted. Participants will serve as their own controls. Eligible participants will after an informed consent complete two study visits, one with and one without ethanol consumption, in a random order. On each study visit, participants are induced a insulin induced hypoglycemia, seven-eight hours after a meal with or without ethanol. Once plasma glucose is below 3.9 mmol/l, a subcutaneous injection of 100 mcg glucagon is administered. Two hours later a second bolus is administered.

NCT ID: NCT02877849 Completed - Clinical trials for Alcohol Use Disorder

Brain Functional Connectivity in Alcohol Use Disorder

Start date: February 9, 2017
Phase:
Study type: Observational

Due to the relapsing nature of alcoholism, excessive alcohol consumption represents a significant cost to US society ($249 billion in 20101). About 64% of those entering treatment will relapse within one year. New interventions targeting the underlying brain biomarkers of relapse vulnerability hold significant promise in reducing this critical public health problem. Using resting functional magnetic resonance imaging (fMRI) we have identified brain biomarkers that support long-term abstinence and brain biomarkers that predict relapse. Our data point to specific brain biomarkers that index higher relapse vulnerability at 11 weeks of abstinence. Many individuals, however, have already relapsed by this time. It is unknown whether these biomarkers can be identified earlier during the recovery period. We need to investigate whether this biomarker of relapse vulnerability can be identified during earlier stages of abstinence. Earlier identification of this biomarker will give valuable information for timely targeted interventions (e.g. closer monitoring, longer stay in treatment program, neuromodulation), increasing the chances of maintaining abstinence. The overall objective of this study is to identify biomarkers of relapse during early abstinence (2-3 weeks of abstinence). A secondary objective is to evaluate whether non-imaging measures such as craving6 and executive function7 add value to prediction models. Findings from this proposal will provide insight into the neurobiology of relapse vulnerability that will inform new treatment strategies needed to improve treatment outcome.