NIAAA Clinical Trials

The information found on our Clinical Trial Requirements for Grants and Contracts pages applies across all NIH institutes, centers, and offices (ICOs). This page provides NIAAA interest areas, types of trials supported, and other funding considerations related to Clinical Trials.

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Clinical Trials Interest Areas

NIAAA supports clinical trials that advance its mission to improve the diagnosis, prevention, treatment, and recovery of alcohol use disorder (AUD) and alcohol-related problems. The following reflects current areas of interest for clinical trial applications.

NIAAA is interested in the following research topics:

  • Medications development and technological devices for the treatment, prevention, or recovery of AUD and related problems.
  • Treatment for Alcohol-Related Organ Damage (AROD), especially Alcohol-Associated Liver Disease (ALD).
  • Integrated treatment approaches for co-occurring AUD and ALD.
  • Precision medicine and phenotype-targeted approaches to AUD treatment.
  • AUD and co-occurring psychiatric or substance use disorders, including drug-drug interaction studies.
  • Prevention and intervention approaches for Fetal Alcohol Spectrum Disorders (FASD).
  • Alcohol and HIV comorbidity, including treatment access and outcomes for people living with HIV.
  • Behavioral interventions for preventing and treating AUD.
  • Combined behavioral, pharmacological, and technological device interventions for AUD.
  • Prevention and recovery support interventions.
  • Prevention of alcohol-related adverse outcomes involving crashes, injury, HIV, pregnancy, suicide, and violence.
  • Screening, Brief Intervention, and Referral to Treatment or Prevention (SBIRT/P) for AUD.
  • Dissemination and implementation of evidence-based AUD treatment and prevention interventions into clinical and community settings.
  • Alcohol health services research, including access to and quality of AUD care.
  • Trials incorporating biomarkers, data science, or multi-omic approaches to predict treatment response or guide recovery.
  • Trials addressing health disparities in AUD diagnosis, treatment access, or treatment outcomes.
  • Trials addressing AUD across the lifespan, including adolescent, young adult, and older adult populations.

Clinical Trials Types of Trials Supported

NIAAA typically supports:

  • Early-stage — including feasibility, Phase I, first-in-human, and safety studies — that inform early-stage technology or treatment development.
  • Proof of concept Phase II safety and efficacy.
  • Single-site trials for early-stage research questions.
  • Multi-site trials for adequately powered efficacy or effectiveness studies to enhance generalizability.
  • Effectiveness.
  • Dissemination and Implementation Science.

NIAAA will not consider funding the following research topics:

  • Trials in which alcohol use, AUD, or an alcohol-related condition is not a primary focus or not applicable to NIAAA’s patient population.
  • Trials evaluating technology or devices that mitigate the acute effects of drinking, where such technology may increase AUD risk by enabling continued or heavier alcohol use.
  • Trials with outcomes that aren’t NIAAA mission focused.
  • NIAAA does not typically support NIH-defined Phase 3 FDA-regulated (pivotal) or Phase 4 (post-marketing) trials.

Clinical Trials Project Period Considerations

The maximum project period for NIAAA-supported clinical trials is 5 years, consistent with NIH policy. The requested period of support should be justified by the scope and design of the proposed trial. Some funding opportunities may specify a different project period and applicants should consult the relevant Notice of Funding Opportunity (NOFO).

 

Clinical Trials Budget Considerations

Budget limitations for clinical trial applications vary by funding mechanism and are specified in the relevant NOFO.

Clinical Trials Contacts

NIAAA Extramural Clinical Trials Operations
[email protected]

For technical issues E-mail OER Webmaster