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Alcohol-Related Disorders clinical trials

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NCT ID: NCT06317987 Not yet recruiting - Clinical trials for Alcohol-Related Disorders

Addressing Barriers to Care for Substance Use Disorder Pilot Study

ABCSUD Pilot
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The Addressing Barriers to Care for Substance Use Disorder Pilot (ABC-SUD Pilot) is a randomized pilot study that will precede a larger trial. The ABC-SUD Pilot is a parallel group, cluster-randomized pilot feasibility trial, with clinicians (care coordinators) as the unit of randomization. This study will be conducted in a mental health treatment access center within the Washington region of Kaiser Permanente. As part of usual care, patients contact the mental health access center and speak to a "care coordinator" to obtain contact information for potential venues to obtain treatment for substance use disorder. The experimental intervention, Care Navigation, will be evaluated for its potential to increase the utilization of substance use disorder treatment among patients who contact the mental health treatment access center. The investigators note that Care Navigation will be delivered by study "care navigators", who are distinct from the health system's care coordinators.

NCT ID: NCT06235411 Not yet recruiting - Depressive Disorder Clinical Trials

Psilocybin in Alcohol Use Disorder With Comorbid Depression

PAD
Start date: January 2024
Phase: N/A
Study type: Interventional

Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approximately 6 hours, psilocybin action appears to be beneficial for preventing alcohol relapse in recently weaned people suffering from comorbid depression. Whilst the public perception of psilocybin therapy is poorly documented in France, the rapid changes in the legal status of psilocybin elsewhere, the positive media coverage of recent trials in depression, and the recent designation as an "innovative therapy" by the FDA could lead to the refusal of randomization of eligible participants. It is therefore essential to evaluate the feasibility and acceptability of psilocybin treatment and blinded randomized design in our clinical population of hospitalized patients with AUD and depressive symptoms. Recent data suggest that the effect size of psilocybin is much higher than other currently available treatments. However, this paradigm shift must be confirmed in our cohort of people with AUD and depressive symptoms, and in the context of treatment in addition to usual care, by an estimation of the expected effect size based on real data. This will allow the sample size to be accurately calculated for a large-scale randomized clinical trial. Finally, the potential mechanisms of action of psilocybin to prevent relapse in AUD with comorbid depression after withdrawal need to be documented. The objective of this pilot study is to evaluate the feasibility, acceptability, neural mechanisms and preliminary results of the effectiveness of psilocybin in the treatment of AUD and depressive symptoms after withdrawal, in addition to usual treatment. The study authors hypothesize that two oral administrations of 25 mg psilocybin at three-week intervals versus a control condition (1 mg psilocybin), in addition to the usual treatment, will be acceptable and feasible in recently withdrawn individuals suffering from AUD and depressive symptoms, between 14 and 60 days after their last alcohol consumption

NCT ID: NCT06070649 Not yet recruiting - Clinical trials for Alcohol-Related Disorders

The Potential Therapeutic Effects of Psychedelic, N, N-dimethyltryptamine (DMT), on Alcohol Use Disorder (AUD)

Start date: June 1, 2024
Phase: Phase 1
Study type: Interventional

This proposed study is a double-blind, randomized, placebo-controlled, parallel-group, laboratory study to determine the effects of DMT, plus psychotherapy, on Alcohol Use Disorder.

NCT ID: NCT05910580 Not yet recruiting - Pregnancy Clinical Trials

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

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

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: - Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? - Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? - Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person SBIRT, telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

NCT ID: NCT05623501 Not yet recruiting - Clinical trials for Alcohol-Related Disorders

Phase I, Dose-Escalation Study of Dihydromyricetin (DHM) to Treat Alcohol-Associated Liver Disease

Start date: January 1, 2024
Phase: Phase 1
Study type: Interventional

The current proposal is designed as a first-in-human Phase 1 open-label, dose-escalation study to assess the safety, pharmacokinetics, and the maximum tolerated dose of DHM among healthy volunteers using a purified form of DHM from a local cGMP compliant source (Master Herbs, Inc).

NCT ID: NCT05341830 Not yet recruiting - Clinical trials for Substance-related Disorders

Housing for Recovery Initiative

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

Recovery housing is a substance-free group home for those exiting drug and alcohol treatment. Individuals live in a recovery-focused environment with others traveling the same journey. Ohio Recovery Housing (ORH) creates and maintains standards of excellence for recovery housing in the state. Each house decides how it operates, with four different "levels" of housing available. These environments have the potential to help build a strong foundation in recovery to improve health, employment, and housing outcomes. ORH and LEO will launch a quasi-experimental study to measure the impact of recovery housing for individuals with substance use disorders. The design relies on variation in the availability of program spots to identify effects. Invitations to join a home will come from a waitlist. As the length of the waitlist is unrelated to applicant characteristics, movement off the waitlist can be considered essentially random. The research team will compare those who receive services to those who do not. The researchers hypothesize that those who participate in recovery housing will have improved health, employment, and housing outcomes compared to individuals who do not receive recovery housing services.

NCT ID: NCT04897295 Not yet recruiting - Clinical trials for Substance Use Disorders

Neurobiological Effects of Transcranial Direct Current Stimulation Treatment in Alcohol Use Disorder

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Background: Alcohol Use Disorder (AUD) is a complex psychiatric disorder, involving several brain areas and neurocircuits. Transcranial Direct Current Stimulation (tDCS) allows to stimulate superficial areas of brain using a weak electrical current. Preliminary data suggest that tDCS may reduce alcohol craving and consumption. Objectives: The main outcome is to test if tDCS can reduce alcohol craving and use and to assess the changes in BDNF and pro-BDNF levels. Secondary outcomes are the assessment of other psychiatric dimensions (mood, behavioral and cognitive alterations) associated with prolonged alcohol use. Eligibility: Healthy, right-handed adults ages 18-65 who do have AUD (moderate to severe). Design: This is a randomized, double-blind, sham-controlled study with three phases: 1) a tDCS intensive treatment phase; 2) follow-up with weekly tDCS stimulation; 3) follow-up without tDCS stimulation. Participants will be screened with: - Psychometric Scales - Medical history - Physical exam - Urine tests and breathalyzer - After being enrolled, baseline behavioral and laboratory data will be collected. In particular, participants will undergo: - Psychometric Scales - Venous blood sample (BDNF/proBDNF levels) Participants will be randomized to real or sham tDCS arm. The stimulation will be delivered daily for five days during the first week (intensive treatment phase) and then weekly for 3 months (follow-up with stimulation). During this period patient will be tested with a behavioral and psychometric evaluation.Therefore, participants will receive 3 follow-up monthly visits without tDCS stimulation, in which behavioral and psychometric data will be collected. Treatment includes: - tDCS: The tDCS will be delivered with a stimulator connected to two sponge electrodes, soaked in a saline solution. The stimulation will be administered at a current intensity of approximately 1 mA, for the duration of 20 minutes. The anode will be placed on the right DLPFC, the cathode on the contralateral cortical area. - BDNF/proBDNF levels: A venous blood sample will be collected before the first stimulation and after the last stimulation of the intensive-stimulation period (first week). The blood sample will be centrifuged within 20 minutes of sampling at 1000 × g for 15 minutes. Then, the serum will be aliquoted and stored at -80 ° C until analysis. - Repeat of screening tests and questionnaires - Urine toxicological screen and breathalyzer

NCT ID: NCT03826238 Not yet recruiting - Clinical trials for Alcohol-Related Disorders

VR Assessment for Alcohol Related Brain Damage

Start date: May 1, 2021
Phase:
Study type: Observational

Pilot study where 10 alcohol-related brain damage (ARBD) patients will undergo a 30-minutes-long cognitive assessment session using the Validation Gate task to evaluate usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients will also be recorded and compared to the ones of age-matched healthy people in order to preliminary explore the existence of possible EEG biomarkers of ARBD.

NCT ID: NCT03335215 Not yet recruiting - Alcohol Disorders Clinical Trials

Cognitive Remediation in Alcohol Disorders

ALCOSTIM
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

The individual and societal cost of alcohol use disorders (TUAL), present in 10% of the population in France, is considerable. Despite psychotherapeutic and drug addiction treatment, the relapse rate remains very high, partly because of their very frequent cognitive disorders. In fact, more than 75% of TUAL patients present to varying degrees neuropsychological alterations that are only rarely detected and never treated. However, these cognitive disorders limit the benefit of psychotherapeutic care, reduce compliance with pharmacological treatments and hinder the patient's ability to change his behavior with respect to alcohol. An innovative way to promote the maintenance of the therapeutic contract, and therefore to reduce alcohol consumption in these patients, would be to improve their cognitive functioning. The objective of this study is to measure the efficacy of a non-drug treatment, based on a specific and personalized cognitive remediation program, compared to a standard treatment in Day Hospitalization, in order to reduce the rate of relapse very high in TUAL. It is a randomized, single-blind study with two parallel groups of patients with post-weaning neuropsychological disorders: REMED (cognitive remediation) and CONTROL (usual care).

NCT ID: NCT00957775 Not yet recruiting - Clinical trials for Substance-Related Disorders

Computer-delivered Psychosocial Intervention for Adolescent Substance Use Disorders

Start date: August 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and evaluate the acceptability and preliminary efficacy of a web-based, skills training program for adolescents with substance use disorders.