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Alcoholism clinical trials

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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: NCT06134128 Recruiting - Clinical trials for Alcohol Use Disorder

Compensatory Cognitive Training Via Telehealth for Veterans With Alcohol Use Disorders

CCT-A
Start date: October 2, 2023
Phase: N/A
Study type: Interventional

Most individuals entering treatment for alcohol use disorders (AUDs) present with cognitive deficits across a range of cognitive domains, and these deficits frequently persist for six months or longer following remission. Cognitive deficits are associated with increased relapse rates, less treatment compliance, and poorer treatment outcomes in individuals seeking substance use treatment. Despite the high rates of cognitive impairments among adults with AUDs and their negative impact on treatment outcomes, current evidence-based treatments for AUDs do not specifically treat or address cognitive symptoms. Accessible (e.g., brief, manualized, delivered via telehealth) and effective treatments for adults with AUDs and cognitive deficits are urgently needed. The primary objective of this study is to assess the feasibility and acceptability of a manualized, 8-week, Compensatory Cognitive Training (CCT) intervention delivered via telehealth for Veterans in early remission from alcohol use disorder (AUD). The investigators hypothesize that Motivationally Enhanced Compensatory Cognitive Training for Addictions (ME-CCT-A) will be feasible and acceptable in a pilot trial of ME-CCT-A delivered via telehealth.

NCT ID: NCT06118580 Recruiting - Clinical trials for Alcohol Use Disorder

Neural Correlates During Alcohol Intoxication

Start date: June 8, 2023
Phase: Phase 2
Study type: Interventional

Alcohol intoxication is responsible for a large proportion of violent crime/assault and personal injury in our society. While a number of variables have been associated with alcohol-related aggression, high trait aggression and impaired executive function have been identified as key factors. Both Alcohol Use Disorder (AUD) and Impulsive Aggression behavior (AGG) are related to impaired social-emotional information processing (SEIP) whereby social threat cues, especially ones that are ambiguous in nature, lead to hostile attribution and negative emotional response to the "other" and, then, aggression against the "other". Thus, understanding the underlying neuroscience of SEIP under the influence of alcohol will be critical to identifying targets for intervention to reduce alcohol-related aggressive behavior. In addition to potential pharmacologic and cognitive-behavioral based interventions, such interventions may also involve the rehabilitation of aberrant neuronal circuits underlying social cognitive function through neuroplasticity-based remediation exercises. This study is designed to see how brain activation of cortico-limbic circuits involving social-emotional information processing, analyzed by fMRI Imaging, are impacted by alcohol administration in those with and without aggressive disorders and with and without alcohol use disorder.

NCT ID: NCT06118346 Recruiting - Clinical trials for Alcohol Use Disorder

A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings

Start date: February 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a Female-Specific Cognitive Behavioral Therapy (CBT) Group as treatment for Alcohol Use Disorder among Veteran women.

NCT ID: NCT06105853 Recruiting - Clinical trials for Alcohol Use Disorder

Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder

A03
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are: What are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to: - alcohol craving? - alcohol use? - their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior? Participants will: - be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test - be exposed to their favorite drink in a bar lab environment - be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing - conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.

NCT ID: NCT06084520 Recruiting - Clinical trials for Alcohol Use Disorder

Translation and Validation of the COMM and ASI-SR

COMMISS
Start date: December 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to translate the COMM (Current opinion misuse measure) form and validate it using the ASI-SR (Addiction severity score-self report)in a Swedish population of pain patients treated with opioids. The secondary aim is to investigate acceptability of the instrument in a Swedish population of pain patients with long-term opioid treatment (LOT). The tertiary aim is to investigate the prevalence of alcohol and illicit substance use in a Swedish population of pain patients with LOT.

NCT ID: NCT06074341 Recruiting - Clinical trials for Alcohol Use Disorder

TeleHealth Resources for IndiVidualizEd Goals (THRIVE) in Alcohol Recovery Study

THRIVE
Start date: September 13, 2023
Phase: N/A
Study type: Interventional

This project will evaluate the effectiveness and mechanisms of mindfulness-based relapse prevention (MBRP) delivered via video conferencing, as compared to referral to online mutual support groups, in supporting long-term whole-person recovery and improvements in neurobiologically-informed domains of addiction among individuals with alcohol use disorder who are interested in reducing or stopping drinking. The project will also examine the reach, effectiveness, adoption, implementation, and maintenance of MBRP as an accessible and freely available continuing care option that supports long-term recovery from alcohol use disorder in all communities nationwide, including medically underserved and health professional shortage areas.

NCT ID: NCT06063200 Recruiting - Clinical trials for Attention Deficit Hyperactivity Disorder

Methylphenidate and Response to Alcohol Cues

Start date: March 20, 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine whether changes in attention levels related to taking a single dose of a medication called methylphenidate, also known as Ritalin, affects responses to alcohol cues. The study will observe the effects of methylphenidate or a placebo on attentional bias and craving responses to alcohol cues through fMRI, EEG, and behavioral testing. Participants will be involved in one remote and two in-person sessions.

NCT ID: NCT06060496 Recruiting - Clinical trials for Alcohol Use Disorder

Theta Burst Stimulation for Alcohol Use Disorder

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).