The federal government has released a report that examines the potential medical uses of psychedelics. It found their capacity to change a person’s “perceptions and self-sense” could be “promising.”
According to the paper from Government Accountability Office, there is a pressing need for more research. However, it notes that since Schedule I substances such as LSD MDMA, and psilocybin are still controlled, getting permission to conduct research may be difficult.
In a section on ongoing challenges, the GAO report, often called Congress’ “watchdog”, states that scientists must follow a series of steps to conduct research. These include getting permission from the U.S. Drug Enforcement Administration and finding drugs of clinical quality to test. They also need to identify appropriate places to store and test these drugs.
GAO continues: “The difficulties associated with conducting large blind trials have limited researchers’ ability to assess the safety and effectiveness” of these drugs, which they need to do to get approval from FDA. FDA approval is required in most cases before prescription medications can be sold on the U.S. market.
Despite obstacles, hundreds of trials on psychedelics have been conducted to determine if they can be used as a treatment for posttraumatic stress disorder and depression.
It says that between 2015 and 2025 over 340 psychedelic trials began or ended. One study, for example, found that the SSRI escitalopram reduced depression symptoms less than psilocybin.
Science & Tech Spotlight: Medical Use of Psychedelics https://t.co/xD6DHLwNcT
— U.S. GAO (@USGAO) March 6, 2025
GAO also identified mental health as a potential opportunity, along with pain management.
The report states that “research has shown that psychoactives such as MDMA and psilocybin decrease anxiety and fear, and have the potential to improve behavior when combined with therapy.” It also adds that “psychedelics appear to show promise” for cancer patients and those with headaches. This is because they “appear promising in treating certain types of pain and inflammation, including migraines and cancer pain.”
The Agency also pointed out that psychedelics are relatively safe compared with other treatments.
“Psychedelics can have side effects that aren’t life-threatening such as nausea or headaches. Some of the side effects can be life-threatening, such as nausea or headaches. In other cases, illicit psychedelics are contaminated with harmful substances, like fentanyl. Although some studies suggest that psychedelics do not usually lead to addiction, their adverse effects haven’t been studied in full.
The GAO report points out that methodological issues are also present. In a blinded study, for example, the participants shouldn’t know if they were given the experimental drug or a control. According to the paper, because of the different effects psychedelics have on their recipients, it’s difficult for trial participants not to know whether they got the treatment.
Government Accountability Office
This may make it more difficult to plan and analyze such studies. Authors wrote that clinical trials tried to circumvent this problem by using an active substitute, like a small dose of a psychoactive. Researchers could also compare this treatment to a standard one such as SSRI.
GAO’s report highlights the fact that the past decade was a time of a great deal of new research on psychedelics.
Researchers administered LSD for the very first time to patients as part of a Phase 3-clinical trial to determine if the drug can effectively treat the generalized anxiety disorder.
It is expected that the study will enroll approximately 200 participants in the U.S., and compares the effects of an LSD proprietary product with a placebo.
In March of last year, the Food and Drug Administration (FDA) granted the LSD product “breakthrough therapy” status as a treatment for GAD.
A scientific review of MDMA conducted last summer found that, out of six trials examining the substance’s potential for treating post-traumatic disorder (PTSD), five of them “provided evidence of its apparent efficacy and safety.”
Researchers called the results “encouraging,” but added that further research would be needed before MDMA therapy is widely used over existing forms of treatments.
This review was conducted after an FDA advisory committee rejected a request to authorise MDMA-assisted treatment. It was almost immediately, though, that a group of veterans and bipartisan legislators resisted this decision.
“What we’re asking for the FDA to recognize is the science,” said Rep. Morgan Luttrell (R-TX), who in a June op-ed for MEDCAN24 criticized the FDA Psychopharmacologic Drugs Advisory Committee for recommending against against MDMA-assisted therapy.
Psilocybin was also subject to extensive research as a substance-use disorder treatment and mental health aid.
A study conducted earlier this year on the effectiveness of the psilocybin assisted therapy in treating methamphetamine addiction found that it was “feasible to implement as an outpatient treatment, didn’t appear to raise safety concerns and showed signs of efficacy warranting further research.”
The Lancet, which did not perform a peer review, published this report as a preprint back in January. The report found that amongst a small number of participants in a stimulant-treatment program, “Methamphetamine addiction decreased, while depression, anxiety and stress all improved between baseline and day 28 or 90.”
The National Institutes of Health last year announced that it would put $2.4 million toward funding studies on the use of psychedelics to treat methamphetamine use disorders—funding that came as federal health officials noted sharp increases in deaths from methamphetamine and other psychostimulants in recent years, with fatal overdoses involving the substances rising nearly fivefold between 2015 and 2022.
In 2023, meanwhile, the National Institute on Drug Abuse (NIDA) announced a $1.5 million funding round to further study psychedelics and addiction.
Psilocybin was already granted federal breakthrough therapy status to treat certain types of depression.
In the past year, the National Center for Complementary and Integrative Health of National Institutes of Health also released an informative web page on psilocybin. It acknowledged the substance’s potential as a treatment for depression, anxiety and alcohol use disorders.
Psilocybin Research: What you need to know about it was also featured on the page “Psilocybin For Mental Health And Addiction” funded by the Federal Government. The research looked at the effects of psilocybin in pain management, migraines and other conditions.
Findings of another recent study suggests that the use of full-spectrum psychedelic mushroom extract has a more powerful effect than chemically synthesized psilocybin alone, which could have implications for psychedelic-assisted therapy. The findings imply that the experience of entheogenic mushrooms may involve a so-called “entourage effect” similar to what’s observed with cannabis and its many components.
A separate study recently published by the American Medical Associatio (AMA) found that single-dose psilocybin use was “not associated with risk of paranoia,” while other adverse effects such as headaches are generally “tolerable and resolved within 48 hours.”
The study published in JAMA Psychiatry involved a double-blind meta-analysis on clinical trials using psilocybin for anxiety and depression between 1966 and last year.
AMA published another recent study that similarly contradicted commonly held beliefs about the potential risks of psychedelics use, finding the substances “may be associated with lower rates of psychotic symptoms among adolescents.”
Also, results of a clinical trial published by AMA in late 2023 “suggest efficacy and safety” of psilocybin-assisted psychotherapy for treatment of bipolar II disorder, a mental health condition often associated with debilitating and difficult-to-treat depressive episodes.
The association also published research earlier that year finding that people with major depression experienced “clinically significant sustained reduction” in their symptoms after just one dose of psilocybin.
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The photo is courtesy Wikimedia/Workman.
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