Active clinical trials for "Alcoholism"

Project STAR aims to examine the feasibility, acceptability, and initial efficacy of a CBT-I supplement to outpatient alcohol and substance use treatment.

The purpose of the present study is to develop and test a mobile mindfulness intervention for Alcohol Use Disorder and PTSD among OEF/OIF veterans

Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.

Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC). Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.

This will be a single site randomized, 2-session, within-subject cross-over design pilot study. 20 enrolled (of 30 consented) subjects reporting varying levels of binge and high intensity drinking, defined as at least 2 episodes of drinking 4 (for women) or 5 (for men) drinks on an occasion over the last 5 weeks, (unless determined by PI that drinking history meets study objectives), will be enrolled. Subjects will be randomized to undergo one session of repetitive transcranial magnetic stimulation (rTMS) or sham immediately followed by the investigators rate control intravenous (IV) alcohol self-administration (ASA) paradigm. Subjects will then return 7-14 days later and undergo the same sequence of events with the opposite intervention (i.e. rTMS or sham) from session 1.

Background: People with alcohol use disorder (AUD) have trouble controlling their drinking. Medications can help some people with AUD but are not effective for many others. Researchers want to test new drugs to better treat the disease. Objective: To see if the investigational drug GLWL-01 is safe to use in people with alcohol problems. Also, to find out if the drug reduces the urge to drink alcohol. Eligibility: People ages 18-70 with Alcohol Use Disorder (AUD) Design: Participants will be screened under protocol 06-DA-N415. Participants will be admitted to the inpatient facility, Clinical Research Unit (CRU) on the Johns Hopkins Bayview Medical Center for up to 21 days. They may leave the CRU on specified days pending approval. All their meals will be provided. They cannot drink alcohol. Participants will take either the study drug or a placebo by mouth twice daily. They will not know which they are receiving. Participants will complete many questionnaires. Participants may have urine tests. Participants will complete tasks on a computer. Participants will have blood samples obtained on some study days. Participants will taste and indicate their preference for sweet liquids. Participants' blood pressure, pulse, respiratory rate, body temperature and weight, heart rate and rhythm will be measured. Participants will have breath testing to obtain information about smoking. Participants will be exposed to alcohol cues, water, and food cues in a bar-like room. Cues are things that might make them feel the urge to eat or drink alcohol. Participants will take part in a virtual buffet experiment. They will wear a virtual reality headset, walk around a virtual room, and select virtual food and drink....

Almost 18 million US adults have alcohol use disorders (AUD), with one third of these individuals also diagnosed with anxiety disorders (AXD). The coexistence of AUD and AXD imposes a high burden via healthcare costs and lost productivity. To date, existing treatment approaches for addressing AUD/AXD comorbidity have been only modestly effective and there is a lack of adequate research to guide treatment decisions. The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has shown efficacy in treating emotional disorders. The efficacy of the UP to facilitate abstinence from alcohol consumption in individuals with comorbid AUD/AXD has also been examined, with results from this study indicating a reduction from baseline in drinks consumed per day. However, further evaluation of the UP for managing AUD/AXD is warranted. In this clinical trial, the investigators will further assess the UP's effectiveness in reducing alcohol consumption in patients with comorbid AUD/AXD. Participants will be randomized to one of two conditions: 1) treatment with the UP or 2) treatment with therapist-guided Take Control (TC; a computerized alcohol reduction program). In addition, in a subset of twenty-five participants, functional magnetic resonance scanning (fMRI) will be used to examine the effects of the UP on changes in brain activity in areas important to regulation of emotional and reward processes implicated in excessive alcohol consumption. The researchers' primary hypotheses are that the UP group will, compared to the TC group: 1) be superior in acute symptom reduction from pre- to post-treatment, and 2) evidence greater reductions in percent days heavy drinking, percent days of drinking per week, and alcohol craving.

Every year, alcohol causes 3 million deaths worldwide. Even though a lot of treatments already exist, many of them are characterized by a high percentage of drop-out or relapse. Transcranial direct current stimulation (tDCS), a NIBS, is receiving increased attention as a possible new addiction treatment. However, little consensus exists in the concrete parameters (e.g. montage, current, intensity). Moreover, a lot of tDCS research focuses on subjective outcomes, like the report of craving, which are more prone to different biases and fluctuations. In this study, we aim to investigate the effect of HD-tDCS, a more focal stimulation variant, on AUDs. Using this intervention, stimulation can be restricted to one hemisphere, controlling for possible inhibition effects of the cathode. A between-subject design will be carried out, including patients with an AUD. Participants will receive 5 sessions of either real or sham right anodal HD-tDCS over the dorsolateral prefrontal cortex (dlPFC). Craving will be accounted for at baseline and after every stimulation session. Moreover, we will measure the activity of the brain in rest and during two inhibition tasks (Go/NoGo and cue reactivity task). This objective measure will be carried out both before (baseline) and at two time points after the stimulation, to measure effects on both the short and longer term. One month after the intervention, abstinence will be checked through a follow-up phone call. Through this study, we aim to describe positive effects of right dlPFC stimulation on craving, abstinence, and EEG measures.

The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in users with substance use disorder or problematic substance use (alcohol and stimulants). Participants are randomly assigned to thirteen different groups to compare the effectiveness of particular long-term interventions. A questionnaire battery assessment is administered (1) at baseline in the first week following onboarding in; (2) after 5 weeks; (3) after six months. In addition, longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment.

Hazardous drinking is common among Veteran primary care patients and increases risk for more costly and complex medical problems over the long-term. Yet, the vast majority of these Veterans go untreated. By providing an option for care that is easily accessible, private, and self-directed, mobile applications (apps) circumvent many barriers to alcohol use treatment. However, poor patient engagement remains the Achilles' heel of these apps. Through supportive accountability, Peer Specialists can maximize the reach and engagement of these apps with patients and improve drinking outcomes. The goal of this project is to evaluate whether an app for alcohol use self-management ("Stand Down") reduces drinking among Veteran primary care patients who engage in hazardous drinking, and for whom Peer-Supported-Stand Down is more effective than the app alone. If successful, the proposed research has the potential to transform care and increase access to alcohol-related services for Veterans who engage in hazardous drinking but rarely seek treatment, and, in turn, mitigate the adverse health outcomes that stem from untreated hazardous drinking.