Active clinical trials for "Alcoholism"

This study aims to compare the efficacy of two types of interventions, which are acceptance and commitment therapy (ACT) as compared with virtual reality exposure therapy (VRET) for alleviating psychological dependence on alcohol and preventing relapse. It also assesses the changes of EEG in patients with alcohol use disorder after completion of the above related interventions. In this study 120 subjects with alcohol use disorder who have completed 2 weeks of in-patient detoxification will be randomized into three groups (VRET, ACT and treatment-as-usual control groups) and undergo respective interventions. Then assessment will be performed at four timelines (baseline, 4 weeks after baseline which is immediately after completion of intervention, 12 weeks after baseline, and 24 weeks after baseline assessment).

This three-armed, parallel-group, single-blind, multi-center randomized control trial (RCT) aims to evaluate the efficacy of probiotic supplement compared with that of acceptance and commitment therapy (ACT) in ameliorating alcohol craving and severity of alcohol use disorder (AUD) in patients diagnosed with AUD after 2 weeks of in-patient detoxification. In addition, this study also compares the efficacy of probiotic supplement and ACT to mitigate common comorbid of AUD (such as depression and anxiety symptoms); changes in event-related potential (ERP) on electroencephalogram (EEG) monitoring which indicate reduce alcohol craving; and depreciate the serum level of pro-inflammatory cytokines, such as interleukin-1β (IL-1β), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) indicating lowering of systemic inflammation. In phase I of the study, 120 patients diagnosed with AUD (using Diagnostic and Statistical Manual for Mental Disorders 5th Edition or DSM-5) and 120 healthy controls will be recruited. The measured outcomes to be compared between patients with AUD and healthy non-AUD controls include ERP on EEG monitoring, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), and the fecal microbiota content. Then, in phase II of the study, 120 AUD patients will be randomized into three groups of intervention in a 1:1:1 ratio (Lactobacillus sp. probiotic, ACT and placebo group; n = 40 per group). The participants in probiotic and placebo groups will then consumed the Lactobacillus sp. Probiotic and placebo 1 sachet once a day of probiotic and placebo, respectively for 12 weeks. While participants in ACT group will undergo training for ACT one session per week for 8 weeks. Outcome assessments will be performed across four time points, such as t0 = before intervention began, t1 = 8 weeks after intervention began, t2 = 12 weeks after intervention began, and t3 = 24 weeks after intervention began. The primary outcomes to be measured are the degree of alcohol craving, alcohol withdrawal, and severity of alcohol use disorder. While the secondary outcomes to be assessed are severity of comorbid depression and anxiety symptoms, serum levels of pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α), changes in ERP on EEG monitoring, and fecal microbiota content.

To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.

This is a randomized controlled trial (RCT), within-subject, crossover, double-blind, placebo-controlled in non-treatment-seeking individuals with Alcohol Use Disorder (AUD) (N=40, 50% female) randomized to IN insulin or placebo. In a bar laboratory setting, randomized participants will receive a single dose of IN insulin (80IU) or an IN matched placebo (0.9% Saline). Participants will undergo a cue-reactivity paradigm followed by an alcohol challenge that includes an alcohol drink designed to raise the breath alcohol content (BrAC) to 0.08g/dL.

Multi-site, double-blinded, prospective, randomized, sham-controlled study

Randomized clinical trial of 10 days Cannabidiol versus placebo as an adjunctive treatment during inpatient alcohol detoxification to improve abstinence in patients with severe alcohol use disorder.

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist. The main question[s] it aims to answer are: Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship. These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder. All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy and around 60% of the patients relapse in the short-term after withdrawal. Lysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated, that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer not up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding. Therefore, the present study aims to evaluate the safety and efficacy of LSD for the treatment of AUD and addresses the shortcomings of previous studies. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for addictive disorders in Switzerland. The study will include 126 patients after withdrawal treatment and will primarily assess the efficacy of LSD for the treatment of AUD. Patients will be treated using a 1:1 allocation. Each arm will last 20 weeks and will comprise nine study visits without drug administration and two study days involving LSD or active placebo administration. In the first session, patients in the treatment group will receive a dose of 150 µg LSD, followed by another 150 µg or 250 µg LSD in the second session, which will take place approximately 4 weeks after the first session. The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD at 3 months follow-up. Additionally, the study will assess neurobiological mechanisms of action and several other measures.

This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.

This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.