Active clinical trials for "Alcohol Drinking"

The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.

The present investigation entails a pilot randomized controlled trial to explore whether a stand-alone, alcohol-reduction, brief intervention (with a module on substance use and depression) would be feasible, acceptable, and potentially efficacious within the context of HIV pre-exposure prophylaxis (PrEP) treatment.

Unhealthy alcohol use (the spectrum from risky consumption through alcohol use disorder, AUD) is a leading cause of preventable death in the US (88,424 deaths annually costing $249 billion a year), and alcohol-related health harms (e.g. AUD itself, cirrhosis) are increasing. Despite high frequency of contacts with the medical system, most people with unhealthy alcohol use do not receive evidence-based interventions due to factors such as stigma, lack of knowledge, challenges with implementing and maintaining tool-based screening, time or prioritization constraints, and more. Electronic health records (EHRs), Best Practice Advisories (BPA) and registries are known and practical tools to improve management and care of chronic disease by aggregating information about the target population, and by assisting the clinician in reminders, decision support, and disease-specific care management. EHRs may help clinicians identify, assess, treat and monitor care when assisted by targeted staff support such as a clinical care manager (CCM) and population health manager (PHM). These support staff help to track outcomes of care and treatments, allowing for increased engagement with the population, and facilitation of care. The study team created a live database/registry of patients with unhealthy alcohol use in the BMC electronic health record (Epic), and updated Epic-based best practice advisories (BPA) and clinical decision support (CDS) (Epic Smart Set) for risky alcohol use and AUD. To improve recognition, management, and overall services provided to patients with AUD, this trial aims to test the impact of these EHR tools (the BPA, CDS, registry and registry-based reporting) for risky alcohol use and AUD by incorporating a population health manager (PHM) and clinical care manager (CCM) to augment reach and support to clinicians, and test the feasibility and effectiveness of leveraging EHRs and targeted supports to improve AUD care. A four-group randomized control trial will be implemented to determine which of four interventions is most effective at increasing rates of initiation and engagement in AUD treatment, as well as other clinical processes and outcomes. The trial will compare the use of the 1) BPA alone (only Epic-based clinician prompting and CDS), 2) BPA + PHM, 3) BPA + CCM, and 4) BPA + PHM + CCM, on the trials' primary, secondary, and exploratory outcomes. Trial results will be assessed by examining outcomes for patients on the clinician's panel.

STUN Alcohol Use Now is an intervention designed to use primary care practice support services (practice facilitation) to help small to medium-size practices (10 or fewer providers) identify and provide services for people with unhealthy alcohol use. The original recruitment goal was 135 primary care practices in North Carolina, which we were unable to meet due to pandemic-related barriers.

Alcohol Use Disorder (AUD) is a significant public health problem, with prevalence rates of 13.9% for current and 29.1% for lifetime diagnosis (Grant et al., 2015). AUD creates harm at the individual, familial, and societal level, with an estimated societal cost of $249 billion (Sacks et al., 2015) per year. The course of AUD typically is characterized by periods of relapse to problematic drinking (Maisto et al., 2014), signaling a need for better treatments and understanding of mechanisms of behavior change. The goal of this research is to conduct a randomized clinical trial with 140 participants who have an Alcohol Use Disorder (AUD). Each participant will complete behavioral assessments, self-report surveys and brain imaging before and after receiving psychotherapy treatment to change their drinking behaviors. Various aspects of behavior change will be looked at to better understand changes in brain function and emotional reactivity when someone changes their patterns of alcohol use. The two treatment used in this study have been found to be helpful in reducing alcohol use. Participants will be randomly assigned to either Mindfulness-Based Relapse Prevention (MBRP) or Cognitive Behavior Therapy (CBT) that will be completed in 12 weekly therapy sessions. It is anticipated that there will be numerous changes in brain function that are found when someone reduces or stops their alcohol use after the completion of 12 weeks of treatment.

More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.

This study uses positron emission tomography imaging of the 18-kDa translocator protein to measure the brain's immune response to alcohol.

The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether changes continue for up to 90 days. The study will also identify barriers and facilitators related to drinking reduction. The project will focus on clinical comorbidities including HIV disease control, cognitive and brain function, liver abnormalities, and chronic inflammation. The study teams propose to enroll 140 HIV+ and 40 HIV- adults with heavy drinking, and then use Contingency Management (CM) with financial incentives to encourage participants to maximally reduce alcohol consumption for 30 days. Participants will be required to wear an ankle biosensor (SCRAM monitor) at all times, which is used to monitor participants' drinking behavior. At 30 days, participants will complete a full day of follow-up, including cognitive testing, neuroimaging, blood testing, liver Fibroscan, and questionnaires. Many participants will also provide a stool sample for gut microbiome assessment at each time point. At 30 days, participants will participate in a motivational interview to discuss perceived benefits and obstacles to drinking reduction, and most participants will continue CM to 90 days (but can opt out at this point). Participants will complete another full-day assessment at 90 days, at which point persons may choose to drink or not on their own (no more CM). A final assessment will be conducted at 12 months. This A-B-A design will enable us to clearly identify whether alcohol effects on cognition and brain function are reversible in the context of HIV, and analyze specific cerebral and systemic pathophysiological factors contributing to these effects. The inclusion of HIV- adults will enable subgroup comparisons of alcohol reduction effects in the context of HIV vs. no-HIV. These HIV-negative participants will be recruited from the same settings as our HIV+ participants, and will include a similar proportion by age, race, and gender as the HIV+ participants. The study team will use information from the MI data and our other assessments to elucidate factors that predict both short term (during CM) and long-term (1-year) alcohol reductions, and study how changes in alcohol consumption affect important HIV clinical outcomes that will be monitored over time.

In order to improve the quality of alcohol-related care for those with unhealthy alcohol use, the current research will use an evidence-based implementation strategy, practice facilitation, at one VA primary care site to pilot test whether practice facilitation has the potential to improve the quality of primary care-based alcohol-related care . It is hypothesized that primary care providers who take part in the practice facilitation intervention will provide higher quality substance use care to Veterans with unhealthy alcohol use compared to care pre-practice facilitation (e.g., administer evidence-based brief counseling interventions at higher rates, prescribe alcohol use disorder pharmacotherapy at higher rates, increase referrals to specialty substance use disorder clinics).

The purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. Depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. Parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. This study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.