Therapeutic Development for Cannabis Use Disorder (CUD)
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Topic Description
Post Date: August 7, 2026
Expiration Date: August 7, 2028
The purpose is to accelerate the development of therapeutic interventions, including medications, devices, digital therapeutics, and behavioral therapies for Cannabis Use Disorders (CUD). This initiative aims to support high-impact preclinical and clinical research projects that will generate critical data necessary to advance promising therapeutics toward U.S. Food and Drug Administration (FDA) approval.
Over the past two decades, cannabis use in the United States has increased substantially. Recent estimates indicate that daily or near-daily cannabis use (approximately 17.7 million individuals) now exceeds daily or near-daily alcohol use (approximately 14.7 million individuals). Nearly 30% of individuals who use cannabis meet diagnostic criteria for CUD, which include 1.2 million adolescents aged 12-17 and 5.5 million young adults aged 18-25.
This growing public health burden is driven in part by changes in the cannabis landscape, including expanded availability, increased social acceptance, and the rising potency of cannabis products, particularly those containing high concentrations of Δ9-tetrahydrocannabinol (THC) and semisynthetic cannabinoids. These factors are associated with higher rates of CUD and a range of other adverse psychiatric and medical outcomes.
Despite its prevalence, there are currently no FDA-approved medications for CUD. Clinical management relies largely on gradual reductions of use and supportive care for withdrawal and craving symptoms. Behavioral interventions, such as contingency management, cognitive-behavioral therapy, and motivational enhancement therapy, show modest effects. Moreover, relatively few clinical trials have evaluated pharmacological and non-pharmacological treatments for CUD. Together, these gaps highlight a critical unmet need for safe, effective, and scalable interventions.
Research Interests
Research areas of interest under this topic include, but are not limited to:
- Pharmacological treatments for CUD
- Medications for acute cannabis intoxication
- Therapeutics for Cannabinoid Hyperemesis Syndrome (CHS)
- Interventions targeting core symptoms of CUD (e.g., craving and withdrawal)
- Treatments for CUD in the context of polysubstance use, with or without comorbid medical conditions
- Non-pharmacological approaches, including neuromodulation, digital therapeutics, and diagnostic tools
It aligns with:
- NIH MAHA Chronic Disease Initiative : The National Institutes of Health (NIH) will launch an Initiative on Chronic Disease to leverage and align existing NIH research projects, improve NIH coordination on chronic disease research, and generate actionable results for diseases arising in childhood and adulthood.
- Repurposed Drugs : The NIH and FDA will jointly investigate opportunities to strengthen the use of repurposed drugs for the treatment of chronic disease, while harmonizing authorization processes through collaborative clinical trial designs to achieve FDA approval.
Participating ICOs
NIDA encourages research spanning the therapeutic development pipeline for CUD, including:
- Chemistry and Pharmaceutics: Lead optimization, development, or expansion of small-molecule libraries, high-throughput screening, medicinal chemistry, formulation, and drug-delivery technologies, prodrug development, and bioassay development relevant to CUD therapeutics.
- Preclinical Development: Pharmacokinetic and pharmacodynamic studies, safety and efficacy evaluations, and drug–drug interaction studies involving cannabis or other substances of abuse.
- Clinical Development:
- Phase I: Assessment of pharmacokinetics, safety, tolerability, dose-ranging, and/or initial efficacy.
- Phase II: Proof-of-concept and pilot studies evaluating safety and efficacy in human subjects.
- Phase III: Large-scale clinical trials assessing safety and efficacy in patients with CUD.
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