Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults (UG3/UH3 Clinical Trial Required)

Ceiling: $3,400,000
Applications Due: Closed
Federal
U.S. Department of Health and Human Services (National Institutes of Health)

The "Safety and Early Efficacy Studies of Psychedelic-Assisted Therapy for Chronic Pain in Older Adults" grant aims to fund a network of clinical trials that will study the safety and potential effectiveness of psychedelic drugs in treating chronic pain in older adults, with a focus on those aged 75 and above.

Description

The purpose of this funding opportunity is to support a multi-center consortium that will function as a clinical trials network to collect safety and early efficacy data in defined groups of older adults with specific chronic pain conditions. This funding opportunity will use a UG3/UH3 phased innovation mechanism, and responsive applications must include a research plan describing both UG3 and UH3 phases. UG3 (1st phase) studies, lasting up to 2 years, should involve preliminary studies in healthy older adults across a broad age range to evaluate safety, pharmacokinetic, and pharmacodynamic properties of psychedelic agents and preliminary testing of study elements that will inform further development and testing in the UH3 (2nd) phase. UH3 studies, lasting up to 3 years, should include expanded safety and preliminary efficacy studies in older adults with chronic pain conditions and include participants with non-contraindicated co-occurring conditions representative of real-world older adults. In both phases of the award, participants across a broad range of ages should be included, with particular attention to strata at the upper age range (i.e., 75-80 years, and 80+ years old). For the purposes of this RFA, the term psychedelic includes classic psychedelics, typically understood to be 5-HT2 agonists such as psilocybin,N,N-Dimethyltryptamine(DMT), lysergic acid diethylamide (LSD), and mescaline, as well as entactogens or empathogens such as methylenedioxymethamphetamine (MDMA). Synthetic analogs of these agents are also included. Cannabis, ketamine, and their related products are not considered psychedelic agents in this RFA.

Eligibility

States
All
Regions
All
Eligible Entities
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal organizations, Public housing authorities, Nonprofits

Funding

Program Funding
$3,400,000
Award Ceiling
$3,400,000
Award Floor
Award Count
1

Timing

Posted Date
April 25, 2024
App Status
No Longer Accepting Applications
Pre-app Deadline
September 10, 2024
Application Deadline
October 10, 2024

Funder

Funding Source
Source Type
Federal
Contact Name
Contact Email
Contact Phone
--

Why Organizations Trust GrantExec

$78.81B
Available Funding
7,151
Active Grants
224
New Grants Analyzed This Week