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Psilocybin in the treatment of methamphetamine use disorder

Award Number: UG3DA067126
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2028

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Psilocybin in the treatment of methamphetamine use disorder - Project Summary/Abstract The overall goal of the current study is to explore the feasibility, acceptability, and potential efficacy of psilocybin-assisted treatment (PAT) for methamphetamine use disorder (MUD). Randomized clinical trial data collected by our research group suggest that PAT might be safe and effective in the treatment of cocaine use disorder. However, methamphetamine, despite also being a major stimulant, displays significant pharmacological and epidemiological differences compared to cocaine, and there are no randomized controlled trial data informing the efficacy of PAT for MUD. In the initial UG3 phase of the current study, we will randomize 12 persons with MUD to receive either 30 mg psilocybin or 5 mg psilocybin (active placebo). During this phase, we will monitor recruitment, retention, and safety while also evaluating subjective drug effects and abstinence from methamphetamine. If the initial UG3 phase suggests feasibility, we will progress to the UH3 phase. In this next trial we will further assess the feasibility and acceptability of PAT for MUD and explore its potential efficacy among 30 persons with MUD who will receive either 30 mg psilocybin or 5 mg psilocybin (active placebo). We will also examine outcomes related to quality of life and psychosocial functioning. Secondary examination of the association of subjective drug effects (e.g., mystical-type experience, psychological insight, emotional breakthrough) with clinical outcomes will further be explored. In short, the proposed studies aim to measure the potential feasibility, safety, and efficacy of PAT for MUD. If these trials are successful, our findings might pave the way for the development of a pharmacotherapy for MUD, which is a substantial public health burden that lacks effective treatment options.


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 = $662,322 )
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Drug Use and Addiction Research Programs	000	1	8/14/2026	NEW	$662,322
2026	2026	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Drug Use and Addiction Research Programs	001	1	8/17/2026	NEW	$0
														Subtotal = $662,322

Grand Total All Awards = $662,322

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Psilocybin in the treatment of methamphetamine use disorder

Award Number: UG3DA067126

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 08/15/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2028

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