No psychedelic is FDA-approved for anxiety. What two small 2016 trials in patients with life-threatening cancer found, what they do not show, and where psilocybin stands under federal and state law.
Two small randomized trials published in December 2016 are described here. Those trials enrolled patients with life-threatening cancer. They are not evidence for anxiety in the general population.
Psilocybin remains classified as a Schedule I controlled substance under federal law. Trials are the route for anxiety-specific study. State programs in Oregon and Colorado allow adult access at state-regulated service centers, and those programs are not anxiety-specific treatment programs.
Both studies evaluated psilocybin delivered with psychotherapy in supervised research settings for patients with life-threatening cancer diagnoses.
The first study was conducted at Johns Hopkins University by Griffiths et al. (2016) and registered on ClinicalTrials.gov as NCT00465595. This randomized, double-blind, cross-over trial enrolled 51 patients with life-threatening cancer diagnoses and symptoms of depression, anxiety, or both. The trial compared a very low placebo-like psilocybin dose with a high dose given in counterbalanced sequence, with five weeks between sessions and a six-month follow-up period.
High-dose psilocybin produced large decreases in clinician-rated and self-rated depressed mood and anxiety. The intervention also produced increases in quality of life, life meaning, and optimism, along with decreases in death anxiety. At six months, about 80% of participants continued to show clinically significant decreases in depressed mood and anxiety. The mystical-type experience on session day mediated the effect of dose on outcomes.
The second study was conducted at New York University by Ross et al. (2016). This double-blind, placebo-controlled, crossover trial enrolled 29 patients with cancer-related anxiety and depression. Participants were randomized to single-dose psilocybin or niacin as placebo, both delivered with psychotherapy, with primary outcomes evaluated at seven weeks before crossover.
Psilocybin produced immediate and sustained improvements in anxiety and depression. The treatment also produced decreases in cancer-related demoralization and hopelessness, along with improvements in spiritual wellbeing and quality of life. At the 6.5-month follow-up, approximately 60 to 80% of participants continued with clinically significant reductions in depression or anxiety. The mystical experience mediated the therapeutic effect.
Both studies were small, conducted in patients with life-threatening cancer, and delivered with psychotherapy in supervised research settings. Each psilocybin anxiety trial evaluated distress connected to serious medical illness. These studies are not evidence for generalized anxiety disorder, social anxiety, panic disorder, or anxiety in the general population.
The two 2016 clinical studies investigated psilocybin for cancer anxiety with psychotherapy. The table below outlines the core parameters evaluated in each trial.
| Trial Parameter | Johns Hopkins Trial | New York University Trial |
|---|---|---|
| Citation | Griffiths et al. (2016) | Ross et al. (2016) |
| Participants | 51 patients | 29 patients |
| Population | Life-threatening cancer with depression and/or anxiety | Cancer-related anxiety and depression |
| Study Design | Randomized, double-blind, cross-over | Double-blind, placebo-controlled, crossover |
| Comparison | Very low dose vs high dose | Single-dose psilocybin vs niacin as placebo |
| Follow-up | 6 months | 6.5 months |
| Mediator | Mystical-type experience | Mystical experience |
The two trials described here were delivered with psychotherapy in supervised research settings. In each trial, the mystical-type experience mediated outcomes.
Completed Phase 3 psilocybin evidence for generalized anxiety disorder, social anxiety and panic disorder is not established on this page. Psilocybin is not approved by the Food and Drug Administration (FDA) for any anxiety condition.
One investigational lysergic acid diethylamide (LSD) drug, DT120, developed by Definium Therapeutics (formerly MindMed MM120), holds FDA Breakthrough Therapy designation for generalized anxiety disorder. Its Phase 3 generalized anxiety disorder trials Voyage in August 2026 and Panorama in September 2026 reported positive sponsor-announced topline results.
DT120 is investigational and is not FDA-approved. Sponsor topline results are not peer-reviewed publications. For full details on that compound, consult our guide to Definium DT120 LSD.
For PTSD, see our guide to psychedelic therapy for PTSD. General information on pharmacology and research appears in our overview of psilocybin.
A psilocybin session can cause acute anxiety, nausea and other short-term effects. Screening by a clinician, supervised settings and disclosure of all medications matter.
Selective serotonin reuptake inhibitors (SSRIs) and other medications may interact with psilocybin. Questions about SSRIs or other medications go to a prescriber. Do not change any medication without your prescriber.
For detailed information on medication interactions, read our guide to psychedelic medication safety and use our medication safety checker. For related information, see our bad trip recovery guide and our guide to integration therapy.
Psilocybin is a Schedule I controlled substance under 21 U.S.C. § 812. Federal law classes Schedule I substances as having no currently accepted medical use and high abuse potential. Trials are the route for anxiety-specific study.
Oregon Measure 109, through a program run by the Oregon Health Authority, and Colorado Proposition 122 allow adult access at state-regulated service centers. Those programs are not anxiety-specific treatment programs.
Legal status changes by jurisdiction and date. To verify the statutes in effect where you live, check our state-by-state legal status tool and read our guide on where psilocybin mushrooms are legal.
Established treatments exist. Discuss options with a licensed clinician.
See our guide to SSRI alternatives, our guide to benzodiazepine alternatives, and our guide to psilocybin vs antidepressants.
If you need support now, visit our crisis resources page.
You can look for studies through our clinical trial finder and access urgent support through our crisis resources page. Discuss any consideration of psilocybin for anxiety with a licensed healthcare provider.
This guide provides general educational information and is not medical or legal advice. Psilocybin is a Schedule I controlled substance under federal law and remains illegal outside authorized channels. Consult a qualified physician or healthcare provider about any medical condition or psychiatric medication.
Psilocybin is not FDA-approved for anxiety and is Schedule I federally. In two small 2016 trials involving patients with life-threatening cancer, psilocybin delivered with psychotherapy produced sustained reductions in anxiety and depression. Those findings do not show that psilocybin works for general anxiety disorders.
No. The Food and Drug Administration (FDA) has not approved psilocybin for generalized anxiety disorder, social anxiety, panic disorder, or any other anxiety condition as of September 29, 2026. Psilocybin is a Schedule I controlled substance under federal law.
Not as an approved anxiety treatment. Psilocybin is a Schedule I controlled substance under 21 U.S.C. § 812. Oregon and Colorado allow adult access at state-regulated service centers, but those programs are not anxiety-specific treatment programs. Clinical trials provide the route for anxiety-specific study.
Both 2016 trials evaluated cancer patients with anxiety and depression using psilocybin alongside psychotherapy. At follow-up (6 months and 6.5 months), about 80% of Hopkins participants and about 60 to 80% of NYU participants continued to show clinically significant reductions. The mystical-type experience on session day mediated these outcomes.
Yes. A psilocybin session can cause acute anxiety, nausea, and other short-term effects. Clinical screening, supervised settings, and complete disclosure of all medications matter.
SSRIs and other medications may interact with psilocybin. Questions about SSRIs or other medications go to a prescriber. Review our guide to psychedelic medication safety and our medication safety checker.
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