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The effects of psilocybin and brain stimulation on the treatment of alcohol use disorder

Award Number: R01AA032237
ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/20/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2030

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The effects of psilocybin and brain stimulation on the treatment of alcohol use disorder - Alcohol Use Disorder (AUD) represents a significant global public health challenge, affecting approximately 29.5 million individuals in the United States according to the 2022 National Survey on Drug Use and Health. Despite its prevalence, fewer than 10% of those diagnosed receive treatment, largely due to current therapies focusing more on maintaining abstinence than on mitigating core issues such as cravings. Cravings, characterized by a strong desire for alcohol, are crucial predictors of relapse, underscoring the need for targeted therapeutic interventions. The proposed research aims to utilize a novel combination of psilocybin and repetitive Transcranial Magnetic Stimulation (rTMS) to target AUD, leveraging their synergistic effects to enhance neural functioning and cognitive control of craving in the prefrontal cortex (PFC). Psilocybin's activation of serotonin 2A receptors facilitates a heightened state of neuroplasticity, providing a window during which rTMS can effectively reinforce and stabilize neural connections. Personalized targeting of rTMS, guided by functional magnetic resonance imaging (fMRI), is critical due to individual variability in brain structure and function, ensuring precise modulation of neural circuits and maximizing therapeutic efficacy. This R01 proposal aims to investigate the efficacy and neural mechanisms of an innovative treatment combining repetitive rTMS and psilocybin for reducing alcohol craving and consumption in individuals with AUD. The study will target the PFC using task-based fMRI-guided rTMS to address alcohol cravings in individuals with moderate to severe AUD. Before drug administration, 72 participants will undergo the Regulation of Craving (ROC) task via task- based fMRI to determine individualized rTMS targets. Participants will be randomized into four treatment arms: 1) rTMS combined with 30 mg psilocybin, 2) rTMS with placebo, 3) psilocybin with sham rTMS, or 4) sham rTMS with placebo. rTMS treatments will be administered over three consecutive days following drug administration and assessed with fMRI, TMS/Electroencephalogram (EEG), and a cognitive control task one week post-administration to evaluate changes in brain function, cognition and craving from baseline. Support will be provided through motivational interviewing, and all procedures will adhere to established best practices at the Johns Hopkins Center for Psychedelic and Consciousness Research. Clinical assessments will include both objective and self-reported measures of alcohol consumption and craving up to 3-months post-drug. The study is pioneering in its approach to harness the synergistic effects of rTMS and psilocybin, potentially enhancing treatment outcomes significantly. By focusing on the neurobiological mechanisms involved in craving regulation and response to AUD treatment, this research could revolutionize therapeutic strategies for AUD, offering new insights into establishing a novel paradigm in the management of alcohol dependence. This innovative approach promises to reduce cravings by addressing both the biological and psychological facets of AUD in a personalized, precision-medicine manner.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $689,697 )
2026	2026	THE JOHNS HOPKINS UNIVERSITY	3400 N CHARLES ST	BALTIMORE	MD	21218	BALTIMORE CITY	USA	Alcohol Research Programs	000	1	9/18/2026	NEW	$689,697
														Subtotal = $689,697

Grand Total All Awards = $689,697

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The effects of psilocybin and brain stimulation on the treatment of alcohol use disorder

Award Number: R01AA032237

ORGANIZATION: NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/20/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2030

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