Objective 1: Enhance Treatment Options for Alcohol Use Disorder and Related Conditions

Currently, there are three medications for AUD approved by the FDA, and they are effective and important treatment aids. Still, given the multiple biological processes that contribute to AUD, new medications are needed to provide a broader spectrum of treatment options.

Pharmacotherapy, especially when combined with behavioral interventions, is an effective, evidence-based component of AUD treatment. NIAAA encourages research to develop a larger number of pharmaceutical treatments for AUD, because people deserve to choose from a range of evidence-based treatment options that can be tailored to their individual needs. In addition, improving the precision of diagnosis could improve patient outcomes. Because AUD is a complex, highly heterogeneous condition, some individuals may, for example, respond best to a medication that helps with craving and relieves impulsivity, whereas others may respond best to a medication that reverses the negative emotional state of withdrawal or protracted withdrawal symptoms.

ALD, a spectrum of liver diseases caused by alcohol misuse, is the most common alcohol-related cause of death. There are no FDA-approved medications for ALD, and current standard medical treatment, such as steroids, may have significant side effects. Through the NIAAA-supported Alcohol-associated Hepatitis Network, researchers can use and contribute to ALD research and gain insights into the causes and treatments of ALD and integrated treatment of ALD and AUD. Development of drugs that act on multiple molecular targets to reverse and prevent progression of liver damage and to reduce alcohol intake can open new opportunities. Research may identify similar strategies for other alcohol-associated organ damage.

AUD also frequently co-occurs with sleep, pain, and mental health disorders, such as anxiety disorders. Medications to address these co-occurring conditions, in coordination with AUD, could vastly improve health outcomes.

Developing effective pharmacotherapies to address AUD, ALD, and other co-occurring conditions and increasing their uptake continue to be major priorities for NIAAA. NIAAA encourages research to support these priorities, for example:

• Harnessing computational and data science approaches to identify and evaluate biological, cognitive, and behavioral markers, endophenotypes, and clinical characteristics that can be used to predict an individual’s response to specific treatments or treatment combinations
• Developing biomarker and biomarker signatures to serve as surrogate endpoints for intervention clinical trials and to improve clinical management of alcohol-associated health conditions
• Validating alternative outcome measures for alcohol pharmacotherapy trials that will be accepted by the FDA for phase II and III trials (i.e., a two-level reduction in the World Health Organization drinking risk levels)
• Developing new or repurposing existing medications to treat AUD, ALD, and other alcohol-associated organ dysfunction such as alcohol-associated pancreatitis and acute respiratory distress syndrome
• Using pharmacoepidemiological approaches to identify potential medication targets to either co-opt existing medications for use in alcohol-related conditions or facilitating the development of new medications, if necessary
• Leveraging high-throughput multi-omics, artificial intelligence (AI), machine learning, and other statistical approaches to identify molecular signatures and other potential targets linked to pharmacotherapy for AUD
• Developing high-throughput screening platforms for discovery of medications to treat AUD
• Exploring new human laboratory paradigms that will help predict efficacy in clinical trials for AUD/ALD medications development
• Assessing the impact of concurrent use of medications for AUD and other co-occurring disorders on, for example, drug interactions and altered drug pharmacokinetics
• Exploring strategies to design innovative clinical trials to study one or more specific phenotype-targeted therapies in the context of co-occurring disorders in AUD patients

Objective 2: Improve and Expand Behavioral Health Strategies for Alcohol Use Disorder

NIAAA-supported research has generated an extensive evidence base supporting the effectiveness of AUD behavioral health strategies that are commonly used today. This evidence has also informed the treatment of other substance use disorders. However, at present, little is known about the effectiveness, uptake, and implementation of evidence-based behavioral health strategies for AUD.

Incorporating new scientific discoveries and digital technologies can improve AUD behavioral health strategies, contributing to more widespread use in clinical practice and greater acceptability and accessibility for all patients. An increased focus on whole person health and culturally informed treatment approaches provides opportunities to enhance health and increase the reach of evidence-based therapies. Translating research on the mechanisms and processes through which evidence-based behavioral treatments work for individuals can inform the refinement of current therapies to be more effective as well as inform the development of new behavioral treatments.

NIAAA encourages research to improve and expand behavioral health strategies for AUD—for example:

• Disseminating and implementing evidence-based behavioral health strategies in real-world treatment and clinical practice settings
• Utilizing technologies (e.g., mobile devices, computers, and web-based applications) to enhance the dissemination of evidence-based behavioral treatments
• Considering social determinants of health in AUD treatment, including how the incorporation of empathy and religious or spiritual assessments influences clinical care in alcohol treatment outcomes
• Conducting pragmatic and/or hybrid effectiveness clinical trials that evaluate evidence-based behavioral health treatments in various real-world settings

Objective 3: Advance Research on Recovery From Alcohol Use Disorder

NIAAA is dedicated to supporting research that explores the complex, individualized nature of recovery from AUD. Just as there are varying manifestations of AUD, there is no single path to recovery. Whereas some people with AUD recover quickly and with minimal intervention, others need longer or more intense treatments and support. Research to identify and characterize the risk, resilience, and other factors that contribute to long-term recovery, including factors that allow some people to recover without formal treatment, can inform interventions to reduce the risk of a return to drinking and facilitate sustained recovery.

To bring clarity to the concept of recovery and to improve consistency across recovery research, NIAAA has developed an operational definition of recovery from AUD. The definition involves remission from AUD and cessation from heavy drinking, which are associated with improvements in dimensions of well-being, quality of life, and biopsychosocial functioning. NIAAA will continue to support research that evaluates the efficacy and effectiveness of treatment strategies that impact long-term recovery, particularly using components outlined in NIAAA’s recovery definition. The generation and analysis of large treatment and recovery data sets that track long-term recovery, with follow-up timepoints after treatment, will be crucial in advancing recovery research.

Continuing care models and other comprehensive recovery support systems hold promise for sustaining longer-term recovery. These systems often include community-based services and supports that aim to improve the overall well-being of individuals and build upon critical strengths and resources of individuals, families, and communities.

NIAAA encourages research to enhance knowledge about recovery from AUD and to inform the development and implementation of effective strategies to support sustained recovery—for example:

• Identifying the role of different components of short- and long-term recovery programs (e.g., behavioral treatments, medications, inpatient or outpatient treatment, long-term follow-up) using NIAAA’s definition of recovery
• Identifying the potential moderating factors in the trajectories of recovery among sub-populations, such as individuals of all races, ethnicities, sexual orientations, gender identities, ages, languages, abilities, socioeconomic statuses, and geographic regions, and individuals with co-occurring health conditions
• Defining and assessing dimensions of functioning, quality of life, and well-being that are integral to sustained recovery, as well as identifying reliable and valid measures of these constructs that can be feasibly adopted in clinical practice
• Exploring the neurobiological, medical, psychological, behavioral (e.g., self-regulation), environmental, social, spiritual, and other quality-of-life mechanisms that influence and enhance recovery
• Evaluating the efficacy and effectiveness of continuing care models and recovery-oriented systems of care in the treatment of and recovery from AUD
• Leveraging digital health technologies to facilitate recovery and monitor long-term changes in outcomes
• Investigating the role of understudied mutual support groups and of spirituality and religion in recovery from AUD
• Investigating the value of AI approaches to developing algorithms for recovery
• Exploring how an individual’s engagement in the community (e.g., religious, civic, and occupational activities) supports recovery from alcohol and other substances, and how and when health care practitioners should support community engagement among individuals in recovery

Objective 4: Reduce Barriers to Effective Treatment

Bridging the gap between individuals who need alcohol treatment and individuals who seek and receive treatment represents a persistent public health challenge. Although evidence-based alcohol treatments exist, there are barriers to effective treatment. These barriers include stigma, reduced access to care, fear of punishment or criminalization, lack of health care coverage/payment options, employment, lack of child care, and lack of awareness of a need for care or of the availability of evidence-based care options, along with the misconception that treatment does not work. Populations such as individuals who are in the criminal justice system, are incarcerated, are unhoused, or have disabilities, face unique and intersecting barriers to treatment. Furthermore, evidence-based treatments are often not disseminated or implemented in real-world settings.

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Health care providers are in a prime position to prevent and address alcohol-related health problems, yet many are unfamiliar with the full range of available evidence-based alcohol prevention strategies, diagnostic tools, or treatment interventions or may be uncomfortable using them because of stigma or lack of training. In addition, as alcohol misuse contributes to and exacerbates other mental and physical health issues, addressing alcohol in the context of routine health care provides the opportunity to reach more individuals, prevent alcohol-specific and alcohol-related health problems before they develop, and identify, diagnose, and address alcohol problems before they become severe.

NIAAA supports efforts to improve care for alcohol-related health issues in a broad range of settings and for use by the full range of professionals involved in treatment. For example, NIAAA developed the Healthcare Professional’s Core Resource on Alcohol (HPCR) to provide the basics of what every health care professional needs to know about alcohol, including the many ways that alcohol can impact a patient’s health, and strategies for prevention and treatment. In the future, NIAAA aims to increase the dissemination of the HPCR to medical and other health care professional schools, health plans, and a broad range of health care professionals in practice.

NIAAA encourages research and other activities to increase the integration of evidence-based interventions for alcohol-related problems in a broad range of health care settings and that improve access to alcohol-related health care services for all—for example:

• Evaluating strategies at various levels (e.g., individual, societal) to increase education about the need for alcohol care and to reduce the stigma of alcohol-associated health problems, with the ultimate goal of encouraging appropriate, evidence-based care
• Enhancing the dissemination, implementation, adoption, adaptation, and sustainment of evidence-based alcohol screening and treatment strategies and longer-term support in real-world treatment settings, including nontraditional settings (e.g., faith-based organizations, shelters for the unstably housed and victims of domestic violence, and agencies for child and family services)
• Identifying and reducing barriers that keep underserved and other populations from seeking and receiving appropriate alcohol-related health care, including challenges with access and affordability
• Understanding the cost and cost-effectiveness of treatment interventions and exploring ways to make treatment more affordable
• Exploring health care models that promote collaboration between primary care and specialty care providers to improve implementation of evidence-based approaches and provide ongoing follow-up services
• Exploring and promoting mechanisms to integrate diagnosis and management of AUD with co-occurring mental health disorders and other health conditions
• Expanding affordable and accessible screening, diagnosis, and treatment options in populations, especially among people at risk for alcohol misuse and AUD such as individuals in the criminal justice system, in the child and family services system, in college, and in certain high stress workplaces