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Alcoholism clinical trials

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NCT ID: NCT06199076 Recruiting - Clinical trials for Alcohol Use Disorder

Experimental Study on Alcohol Use and Behavior in Young Adults

OXYCAC
Start date: October 17, 2023
Phase: Phase 2
Study type: Interventional

The goal of this double blind randomized placebo-controlled clinical trial is to compare intranasal oxytocin and placebo in young adult individuals with alcohol use disorder as compared to healthy controls. The main questions it aims to answer are: - The effect of oxytocin versus placebo on prosocial behavior in individuals with high- versus low alcohol use - The effect of oxytocin versus placebo on impulsivity, emotion recognition, social learning, and alcohol craving in individuals with high- versus low alcohol use Participants in both groups will on two separate visits perform the following validated behavioral task measures: - Dictator game tasks assessing prosocial behavior - Delay discounting task assessing impulsivity - Emotion recognition task assessing emotion recognition - Alcohol cue craving task assessing alcohol craving - Observational fear learning task assessing social learning Researchers will compare groups of high and low alcohol use to see if there is a difference in effect of oxytocin versus placebo between groups.

NCT ID: NCT06190236 Recruiting - Clinical trials for Alcohol Use Disorder

Integration of Neurofunctional Phenotyping Into Investigation of CBT4CBT for AUD

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

Alcohol use and misuse are prevalent in the United States. Alcohol use disorder (AUD) is the most common substance use disorder. Evidence-based treatments are effective; however, most people with AUD do not receive treatment, and among those who do, responses to treatment modalities vary. Technology provides the opportunity to expand treatment and improve outcomes. Therefore, the overall goal of this project is to incorporate neurofunctional phenotyping into a preliminary investigation of the feasibility of providing mobile CBT4CBT for AUD among a non-treatment seeking population

NCT ID: NCT06175507 Not yet recruiting - Clinical trials for Alcohol Liver Disease

Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.

Start date: December 25, 2023
Phase: N/A
Study type: Interventional

ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve survival. Baclofen is GABA-B receptor agonist and it is safe in cirrhotic patient for alcohol abstinence i.e. already proven and naltrexone is Delta and k-opioid receptor antagonist and it is safe in cirrhotic for alcohol abstinence i.e, proven in ILBS.

NCT ID: NCT06173973 Enrolling by invitation - Clinical trials for Alcohol Use Disorder

Effects of Ketone Supplementation on Acute Alcohol Withdrawal

Start date: March 11, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to study the effects of the ketone supplement Kenetik compared to placebo (an inactive beverage) on alcohol withdrawal symptoms during the 5 days of clinical alcohol withdrawal management treatment at the Caron Treatment Center.

NCT ID: NCT06163651 Not yet recruiting - Pregnancy Related Clinical Trials

Evaluating a One-Year Version of the Parent-Child Assistance Program

PCAP-1
Start date: September 2024
Phase: N/A
Study type: Interventional

The proposed project seeks to achieve four objectives that will, collectively, evaluate the effectiveness of a one-year version of the Parent-Child Assistance Program (PCAP-1) -a model for a home visitation and case management program for parents who used substances during pregnancy. First, the proposed project aims to estimate the causal impact of PCAP-1 on preventing the need for foster care and promoting reunification. Second, the project will estimate PCAP-1's effectiveness in achieving other program goals: parent recovery, parent's connection with needed comprehensive community resources, and preventing future children from being exposed to drugs and alcohol prenatally. Third, the project intends to estimate any cost savings from the perspective of the state. Finally, causal evidence of program effectiveness across the prior three objectives would enable PCAP-1 to be rated according to strength of evidence on relevant federal registries (i.e., FFPSA and HOMEVEE). All four objectives will be pursued by leveraging an ongoing randomized control trial (RCT) of PCAP with substantial backing from public and private partners, including the Oklahoma Department of Human Services (OK's Title IV-E agency). This quasi-experimental project will recruit 40 new participants to receive PCAP-1 services and will use data on participants from the existing trial for the control group. This extension of the original RCT is efficient and highly feasible, drawing upon and adapting an existing evaluation framework and protocol. This design will facilitate an unbiased estimation of one-year program effectiveness while also enabling a comparison of the differential effectiveness of PCAP-1 and the original three-year PCAP model as a secondary benefit. Moreover, given that the population PCAP serves are disproportionately poor and low-income and PCAP is designed to be culturally competent and relevant, PCAP-1 harbors the potential to address inequities in child welfare outcomes, substance use disorder treatment services, and child and family well- being by improving outcomes for these families. With a strong backing by state agencies and community partners, the evaluation of PCAP-1 will contribute to a knowledge gap in the field for in-home program models serving a highly vulnerable population with high rates of child welfare involvement and use of foster care.

NCT ID: NCT06160232 Not yet recruiting - Clinical trials for Severe Alcohol Use Disorder

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder

Start date: January 15, 2024
Phase: Phase 2
Study type: Interventional

Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial

NCT ID: NCT06147622 Not yet recruiting - Clinical trials for Alcohol Use Disorder

A Study to Assess the Pharmacokinetic Profile of Prazosin and Cyproheptadine

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The study is an open-label, randomized,2-period, single dose, crossover study in 8 healthy male/female volunteers. Subjects will be randomized to the following sequences: (A) Period 1: KT110 - wash-out period - Period 2: Alpress and Periactin marketed tablets ; Or (B) Period 1: Alpress and Periactin marketed tablets - wash-out period - Period 2: KT110

NCT ID: NCT06143059 Recruiting - Clinical trials for Alcohol Use Disorder

The Effects of Sex Hormones and Alcohol on Sleep

Start date: January 8, 2024
Phase: Phase 3
Study type: Interventional

Rates of heavy drinking and Alcohol Use Disorder (AUD) are increasing in women, but research on alcohol-related harms in women - including alcohol's impact on sleep - has been minimal. Numerous studies in men show that alcohol impairs sleep, and preliminary evidence suggests that women may be even more sensitive to alcohol-disrupted sleep due to their sex hormones, which fluctuate across both their menstrual cycles and their reproductive lifespans. This study will investigate the influence of sex, menstrual cycle phase, and sex hormones on alcohol-disrupted sleep in adults ages 21-45. Healthy women and men will complete two sets of placebo-controlled lab sessions, during the mid-follicular and late luteal phases of female participants' menstrual cycles. During these sessions, participants will receive a dose of alcohol or a placebo (saline) and they will then be monitored (with polysomnography) while they sleep. At-home sleep and alcohol use will also be measured through actigraphy, daily sleep and wake diaries, and alcohol wrist sensors. Investigators hypothesize that women will show greater disruption of sleep following alcohol use or administration than men, and that alcohol-disrupted sleep will be more pronounced in the late luteal phase compared to the mid-follicular phase. Investigators also expect that estradiol will be negatively associated with alcohol-disrupted sleep, whereas progesterone will be positively associated with alcohol-disrupted sleep.

NCT ID: NCT06139224 Recruiting - Clinical trials for Alcohol Use Disorder

Gut Microbiota-Mediated Inflammatory Interactions Between AUD and HIV Infection

Start date: March 6, 2024
Phase: N/A
Study type: Interventional

Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 20 HIV+ ART+ (10 AUD- and 10 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept observational study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will have two study visits, where stool collection and blood draw will be collected, as well as questionnaires. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. We will recruit the following groups of participants: HIV+ ART+ AUD-; HIV+ ART+ AUD+; HIV- AUD- ; HIV- AUD+. Blood, urine, stool, and intestinal biopsies will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois. Second, lleal/colonic organoids from HIV- and HIV ART+ individuals will be generated to examine their resilience to alcohol-induced intestinal barrier disruption.

NCT ID: NCT06136195 Not yet recruiting - Alcohol Consumption Clinical Trials

Influence of Mavoglurant on Alcohol Craving and Drinking in Heavy Drinkers

Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to find out about the effects of a drug called mavoglurant on alcohol consumption.