View clinical trials related to Alcoholism.
Filter by:The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are: - Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? - Is treatment with psilocybin and therapy safe for participants? Participants will - Attend 13 study visits - Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo - Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
Remote breath alcohol monitors have been increasingly adopted for use in clinical, research and forensic settings to monitor alcohol use because they offer several key advantages over other available monitoring methods. However, it remains unknown if remote breathalyzers reliably detect alcohol use because there is up to a 10-hour window of time when breath samples are not obtained (to allow for sleeping). Additionally, the investigators will examine whether a supplemental measurement of a blood alcohol use biomarker (phosphatidylethanol) can confirm abstinence and/or detect individuals engaging in late-evening drinking to avoid the negative consequences associated with detected alcohol use.
Alcohol Use Disorder (AUD) is a major public health problem, characterized by a high rate of relapse. Chronic and excessive alcohol consumption notably induces frontal brain alterations and cognitive impairments such as executive dysfunction and an attentional bias for alcohol, participating to the risk of relapse. In effect, AUD patients preferentially process alcohol-related cues, which could reflect a reorganization of the patients' semantic network. The investigators hypothesize that in AUD patients, semantic associations in memory are reorganized with a higher centrality of alcohol-related elements. To the investigators knowledge, no studies have explored semantic associations and/or semantic networks in AUD. A study, conducted in patients with neurological damage, showed that frontal lesions are associated with excessive strength in semantic associations, and difficulties to generate remote associations. This excessive strength in semantic associations could reduce the ability to inhibit automatisms and to adapt to new context. Objective: The objective of this study is to explore whether and how AUD patients have a different organization of semantic associations than healthy controls, and whether this reorganization influences the alcohol consumption over the months following the withdrawal. The investigators will also explore how it relates to neuropsychological assessment of flexibility, executive functions, and impulsivity. To these purposes, the investigators will use two original verbal tasks (Free Generation of Associates Task, FGAT and Associative Judgment Task, AJT) assessing word associations and allowing the estimation of semantic networks using graph theory, in combination with neuropsychological testing, in AUD patients and in healthy controls. Methods: This study will include a group of 30 AUD patients and a group of 30 healthy controls. Both groups will be assessed twice, at baseline (T1; early in abstinence for AUD patients) and after a three-month period (T3). For the two groups, T1 and T3 assessments will include the two semantic association tasks (FGAT and AJT). For AUD patients, assessments will also involve neuropsychological testing of impulsivity, flexibility, and attentional bias. Besides, in AUD patients, data about alcohol consumptions will be collected six weeks (T2) and three months (T3) following the baseline assessment to classify patients as relapsers or abstainers.
Rationale: Alcohol-Avoidance Training (AAT) has been used successfully to strengthen avoidance-tendencies in patients with alcohol use disorder (AUD). AAT is already recommended in German clinical treatment guidelines as an evidence-based treatment for AUD and may be incorporated in the next revision of the Dutch clinical guidelines on AUD. Studies in other fields (semantic learning) suggest that spaced learning may be superior to massed learning, but this has not been studied with regard to AAT. Objectives: To compare the effectiveness of spaced versus massed AAT sessions. Study design: a two armed, randomised controlled trail. All participants will receive AAT in addition to routine clinical care in an inpatient setting (Treatment As Usual; TAU). AAT sessions in the experimental group (AAT-S) will be spaced out over four weeks following detoxification. Sessions in the control group (AAT-M) are massed within one week following detoxification. Assessments of alcohol consumption and craving take place before the start of AAT (baseline: T0, timeframe: last 30 days before admission (alcohol use) or past week (craving)) at three (T1) and six months follow-up (T2). Study population: 200 patients with a primary DSM-5 diagnosis of AUD who receive TAU at three addiction care sites (clinical facilities 'Zevenaar', 'Tiel' and 'Wolfheze') of IrisZorg. Patients have finished alcohol detoxification, age ≥ 18, have good Dutch proficiency and have given written informed consent. During the follow-up assessments they are likely to have progressed to regular outpatient addiction treatment. Intervention: During their four week (minimum) admission all participants receive TAU, which includes Community Reinforcement Approach (CRA) (Meyers & Smith, 1995) grouptraining, AAT, sociotherapy and pharmacotherapy. AAT is a Cognitive Bias Modification paradigm that is used to retrain alcohol approach biases. In AAT participants must react to pictures of alcoholic and non-alcoholic beverages with a joystick to the tilt of the pictures which are presented on a computer screen. In current routine clinical care AAT sessions are massed in the first week after detoxification (control condition: AAT-M). In the experimental condition AAT trails will be spaced out over four weekly sessions instead of one week (AAT-S). Main study parameters/endpoints: Changes from baseline to three and six month follow-up in: 1. Mean daily units of alcohol consumed (past 30 days); at baseline this refers to the 30 days directly pre-admission). 2. Mean ratings of mean alcohol craving (past seven days). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants in both conditions will receive the same amount of AAT sessions and trials. Sessions in the AAT-S condition will be spread out over four weeks. Participants in this condition will therefore be exposed to AAT alcohol pictures over a longer period. Given our current experience of AAT as part of TAU, we expect little risk of participants experiencing more sensations of craving. Alcohol (use) is discussed daily during admission as part of TAU. As an extra burden, participants will be asked to complete a questionnaire before the first AAT session. Participants will be approached for follow-up assessment three and six months following the first month of inpatient treatment. Participants receive an incentive (a voucher worth €15,-) after completing all FU assessments, as a compensation for the extra burden.
Alcohol use disorder (AUD) inflicts enormous physical, emotional, and financial burdens on the individual and society at large. Insomnia is highly prevalent among individuals with AUD, and disrupted sleep contributes substantially to alcohol-related problems. While research suggests that treating insomnia may effectively reduce AUD, the degree to which treating insomnia in heavy drinkers reduces alcohol consumption and prevents the onset of severe AUD is not known. This study will be the first to evaluate an Internet-based version of cognitive behavioral therapy for insomnia (CBT-I) in community-dwelling, heavy drinking adults with insomnia. Sleep Healthy Using the Internet (SHUTi), the most widely-used and well-validated version of Internet-based CBT-I will be used. The primary aim is to reduce alcohol consumption and insomnia severity in this population.
The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder. After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.
A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3004
The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
This research project uses a Community-Based Participatory Research (CBPR) framework to test the efficacy of a culturally adapted relapse prevention intervention developed collaboratively by community partners from the Fort Peck Indian Reservation in northeastern Montana and research partners from Montana State University. The Indigenous Recovery Planning intervention employs trained Fort Peck community members to deliver manualized intervention content to American Indian adults with substance use disorder (SUD). By increasing access to culturally responsive evidence-based treatment, this research aims to decrease SUD-related health disparities and improve public health outcomes for underserved Native communities locally and nationally.