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Alcohol Drinking clinical trials

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NCT ID: NCT03252756 Completed - Clinical trials for Alcohol Use Disorder

Effects of Cannabidiol in Alcohol Use Disorder

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

The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD to those of placebo in AUD patients. Participants with AUD will be randomized to receive either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and motoric function), and physiological and psychological domains relevant to AUD (including self-reported craving, depression, and anxiety, and responses to personalized scripts designed to elicit stress- and cue-induced craving and anxiety). Assessments will be conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs. placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.

NCT ID: NCT03248167 Completed - Clinical trials for Alcohol Use Disorder

Cannabidiol as a Treatment for AUD Comorbid With PTSD

Start date: September 16, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.

NCT ID: NCT03246490 Completed - Alcohol Drinking Clinical Trials

A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data

Alcogait
Start date: December 12, 2017
Phase: N/A
Study type: Interventional

This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.

NCT ID: NCT03238300 Completed - Alcohol Drinking Clinical Trials

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

Start date: October 16, 2017
Phase: Phase 2
Study type: Interventional

This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI).

NCT ID: NCT03232112 Completed - Addiction, Alcohol Clinical Trials

Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?

EXALT
Start date: August 7, 2017
Phase: Phase 2
Study type: Interventional

The study is a double-blinded, randomized, placebo-controlled, 26-weeks clinical trial. The objective of the trial is to investigate the effects of the GLP-1 receptor agonist Bydureon® (exenatide) vs. placebo on alcohol intake in patients with a diagnosis of alcohol dependence.

NCT ID: NCT03216954 Completed - Clinical trials for Alcohol Use Disorder

Influence of n-Acetylcysteine Maintenance on Alcohol Effects

Start date: September 15, 2017
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.

NCT ID: NCT03176953 Completed - Clinical trials for PTSD and Alcohol Use Disorder

Topiramate and Prolonged Exposure

TOP
Start date: November 1, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effective when individuals also have AUD. Anti-relapse medication appears promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD symptoms and improve functioning. This study compares PE with and without topiramate, a medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined PE and topiramate will be more effective than PE and placebo. The aim of this grant is to improve treatment outcomes for Veterans with AUD and PTSD.

NCT ID: NCT03159286 Completed - Risk-Taking Clinical Trials

Experimental Test of Facebook Social Drinking Norms on Adolescent Alcohol Use

Network
Start date: March 22, 2017
Phase: N/A
Study type: Interventional

The proposed research will be the first study to focus on experimentally manipulating both injunctive and descriptive norms on social networking sites in order to elucidate the relationship between alcohol and abstainer displays on social networking sites and subsequent alcohol cognitions, use, and related negative consequences. Based on literature focusing on developmentally appropriate health models for adolescents, the Prototype Willingness Model (PWM) assumes that health-risk behaviors occur either when individuals have developed intentions to engage in a risk behavior (and these intentions vary as a function of attitudes and perceived injunctive norms) or through willingness to engage in risks (which varies as a function of perceived vulnerability to negative consequences, perceived descriptive norms , and prototypes). To fully understand the relationships between alcohol abstaining displays on social networking sites, we will examine 1) the role of descriptive and injunctive abstainer and user norms, when experimentally manipulated with SNS profiles, on willingness and intentions, subsequent alcohol use and related negative consequences among adolescents (age 1 5-20) 2) whether intentions and willingness mediate the relation between our experimental manipulation and subsequent alcohol use and negative consequences and whether 3) individual differences in social influence moderate the effect of the experimental manipulation on intentions, willingness, alcohol use, and negative consequences. We will test these aims by recruiting a community sample of adolescents (N = 300), living in the greater Seattle metropolitan area. Participants will complete a web-based baseline assessment and participate in an in-person experimental manipulation in which they are either assigned to see same-sex social networking site profiles of alcohol abstainers, abstainers +users, or a control condition where neither user or abstainer information will be provided. Immediately after the manipulation, participants will answer a series of questions about the profiles they just viewed and their alcohol-related cognitions. Participants will also complete a one-month in person follow up assessment to test for impacts on intentions, willingness, alcohol use, and related negative consequences. Additionally, individual differences in social influence will be examined as possible moderators o f the relationship between SNS-portrayed norms and our primary outcomes. This study is both significant and innovative in that it uses a theoretical perspective to experimentally test the impact of alcohol content, in particular abstainer norms, on Facebook on adolescent alcohol use and related cognitions. The results have the potential to inform preventative interventions while addressing NIH priorities.

NCT ID: NCT03155542 Completed - Clinical trials for Colorectal Neoplasms

Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer

Start date: December 2016
Phase: N/A
Study type: Observational

According to the statistic reports from World Health Organization (WHO) International Agency for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover, based on the statistics from Health Promotion Administration, Ministry of Health and Welfare in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third respectively among call cancer in Taiwanese population. However, if colorectal cancer is diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer is only approximately 10%. Therefore, the screening, early diagnosis od colorectal cancer is crucial. To date, there are some known risk factors for colorectal cancer, including familial adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as an important risk factor for colorectal cancer, and the risk could be higher among Asian population because of the reduced enzymatic activity of some of the alcohol metabolizing enzymes. Thus, through this study, the investigators hope to find out the risk factors of colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene polymorphisms and their interaction with environmental factors, to attain the purpose of early prevention of colorectal cancer.

NCT ID: NCT03137082 Completed - Alcohol Abstinence Clinical Trials

Guanfacine to Reduce Relapse Risk in Women With Alcohol Use Disorder (AUD)

Start date: July 12, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Guanfacine may preferentially reduce craving and improve cognitive control in women with Alcohol Use Disorder (AUD), compared to men. As these behaviors are related to relapse, the objectives of this study are to conduct a 10-week out-patient clinical trial to examine the effects of Guanfacine Extended Release (XR; 3mgs) versus placebo on drinking measures in women with AUD.