WHAT THE STUDY ACTUALLY SAYSIn 62 adults scanned under psilocybin during rest, meditation, music, and film, brain networks reorganized differently by setting — and more reorganization tracked with more positive experiences.
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THE DRUG DOCKETThe agency compressed review of three psychedelic therapies from a year to weeks. A first approval decision is plausible by early 2027.
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ANALYSISA review pooling 23 studies found risk concentrated among people with bipolar I disorder, family history, or unsupervised use. About 4% later transitioned to bipolar disorder.
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THE DRUG DOCKETBy the study's end, 70% had scores low enough to be considered near-resolution. There was no placebo arm — every participant knew what they'd received.
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WHAT THE STUDY ACTUALLY SAYSEPISODE randomized 144 people with treatment-resistant depression across four arms. High-dose psilocybin missed its main outcome, even as secondary measures showed symptom benefit.
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THE DRUG DOCKETNo medication has proven effective for cocaine use disorder. A single psilocybin dose, paired with therapy, produced more abstinent days and a longer time to relapse than an active placebo.
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THE DRUG DOCKETIn 35 patients with recurrent major depression, psilocybin beat an active placebo through day 42. On self-reported measures the effect lingered further, but the trial's primary endpoint showed no difference at 365 days.
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THE DRUG DOCKETTSND-201 improved PTSD severity, disability, and depression scores over placebo in 65 participants — delivered as an oral dose with monitoring but no formal psychotherapy alongside it.
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WHAT THE STUDY ACTUALLY SAYSTwenty-four healthy volunteers received all three drugs in a crossover trial. At 30 mg, 2C-B matched MDMA's intensity and produced psilocybin-like states, without psilocybin's anxiety.
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THE DRUG DOCKETThe open-label pilot tested a specific worry in psychedelic research — that borderline personality disorder blunts response to psilocybin for depression. In this small sample, it didn't.
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WHAT THE STUDY ACTUALLY SAYSA survey of 243 people reporting persistent difficulty after a psychedelic trip found that how they responded in the moment, avoiding versus accepting, predicted whether trauma symptoms followed.
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THE DRUG DOCKETMost psychedelic depression trials require patients to come off antidepressants first. This one deliberately didn't — and found intranasal 5-MeO-DMT tolerable and encouraging in patients who stayed on their SSRI.
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THE DRUG DOCKETUp to eight sessions of psilocybin, layered onto a small randomized comparison against an active placebo, produced a 73% response rate by the end of treatment. The trial was designed to test safety first.
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THE DRUG DOCKETSix months out, 40.5% of smokers given one high dose of psilocybin plus therapy stayed abstinent, versus 10% on the nicotine patch plus the same therapy. The trial ran 82 people.
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WHAT THE STUDY ACTUALLY SAYSPooling 31 studies of 556 patients, cortical 5-HT2A binding was lower in unmedicated depression than in controls. The post-mortem studies mostly found nothing, and the tracers used shape the result.
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