clinical trial design

Addressing blinding in classic psychedelic studies with innovative active placebos

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This research paper discusses how scientists can better test whether psychedelic drugs actually work by improving the way they conduct clinical trials. A major problem is that psychedelic drugs produce obvious effects that make it easy for patients and researchers to figure out who received the real drug versus a fake one. The authors recommend using different types of drugs as placebos that produce similar effects without being therapeutic themselves, such as certain existing medications. By using these better-designed placebos along with other strategies, future research can more definitively prove whether psychedelics truly help treat depression, chronic pain, and other conditions.

Novel psychedelic interventions for post-traumatic stress disorder and their promise for precision medicine

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This review examines how psychedelic drugs like ketamine, MDMA, and psilocybin could offer new hope for people with PTSD by working on the brain differently than current medications. These compounds work quickly and help the brain form new neural connections that can help people process traumatic memories more effectively. When combined with therapy, these drugs show promise in reducing PTSD symptoms faster and more effectively than traditional antidepressants. The review also explains how doctors could use personalized medicine approaches using brain scans and genetic testing to determine which treatment would work best for each individual patient.

From Efficacy to Effectiveness: Evaluating Psychedelic Randomized Controlled Trials for Trustworthy Evidence-Based Policy and Practice

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This paper discusses why testing psychedelic therapies in clinical trials is more complicated than testing regular drugs. When people take psychedelics like MDMA or psilocybin, they clearly notice the effects, which makes it hard to keep the study ‘blinded’ (where neither patients nor researchers know who got the real drug). The author argues that for therapies combining drugs with counseling, this actually makes sense because the therapy itself is part of how the treatment works, not just a confounding factor. However, for stand-alone drug use, this unblinding is a real problem that makes it unclear whether the drug or people’s expectations caused the improvement.

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication

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Researchers tested whether people with severe depression could take psilocybin (a compound from certain mushrooms) while staying on their antidepressant medications. In this study of 19 people, those who received psilocybin with psychological support while continuing their SSRI showed significant improvement in depression symptoms over three weeks, with response rates of 42%. Side effects were mostly mild and temporary, suggesting this approach may be safe and effective without requiring patients to stop their current antidepressants.

Exploring psychedelic use in athletes and their attitudes toward psilocybin-assisted therapy in concussion recovery

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This study surveyed athletes and sports staff in Canada and the United States about their views on using psilocybin-assisted therapy to treat concussion symptoms. Researchers found that about 36% of athletes had used psychedelics in the past year, with psilocybin being the most common. Most athletes (61%) and staff (71%) said they would be willing to try or support psilocybin therapy for concussion recovery if research showed it was beneficial. The main factor influencing willingness was knowledge about psilocybin and positive attitudes toward it.

Psychedelics and the treatment of eating disorders: considerations for future research and practice

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As researchers explore using psychedelic drugs like psilocybin to treat eating disorders, this article outlines important safety considerations and ethical guidelines needed before widespread use. While some early trials show promise, significant concerns exist including physiological risks (heart problems, nausea), psychological challenges, potential for therapist misconduct, and medication interactions. The authors recommend rigorous research designs, better inclusion of diverse populations, and careful integration of psychedelics with proven eating disorder treatments.

The Effect of Fungal Nutraceutical Supplementation on Postoperative Complications, Inflammatory Factors and Fecal Microbiota in Patients Undergoing Colorectal Cancer Surgery with Curative Intent: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

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Researchers tested whether a supplement made from nine different medicinal mushroom types could reduce complications after colorectal cancer surgery. While the supplement didn’t significantly reduce overall complications, it did appear to boost immune function in patients undergoing traditional surgery and favorably changed the composition of gut bacteria. The supplement was well-tolerated with no serious side effects.

Body mass index (BMI) does not predict responses to psilocybin

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Researchers investigated whether a person’s body weight affects how they respond to psilocybin-assisted therapy. Analyzing 77 participants across three studies, they found that BMI did not predict how intensely people experienced the drug or how much their mental health improved afterward. This surprising finding suggests that everyone might benefit from the same fixed dose of psilocybin rather than doses adjusted to body weight, making therapy simpler and more cost-effective to deliver at scale.

Psychedelic-assisted therapy – supposedly paradigm-shifting research with poor attempts at hypotheses falsifying and questionable ethics

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This paper critically examines recent clinical trials testing MDMA and psilocybin for treating PTSD and depression. While these trials reported promising results, the author identifies serious scientific and ethical problems: participants could tell whether they received the drug or placebo due to its strong effects, researchers and therapists who strongly believed in the treatment may have unconsciously influenced patient responses, and negative side effects may have been downplayed. The author argues that without fixing these problems, the entire field of psychedelic therapy research could lose credibility.

Ketamine, Psychedelics, and Psychotherapy: Reframing, Redefining, Renaming Treatment Models

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This paper addresses confusion about how ketamine and psychedelics are being used to treat mental health conditions like depression and PTSD. The authors propose new clear definitions to distinguish whether these drugs are used alone for their chemical effects, combined with established talk therapies, or used to create experiences that are then processed in therapy. Using these clearer definitions will help patients, doctors, and regulators better understand what treatments involve and make more informed decisions.

Research Keyword: clinical trial design