Psychedelics in Psychiatry: Oh, What A Trip!

American Journal of Psychiatry, Год журнала: 2025, Номер 182(1), С. 1 - 5

Опубликована: Янв. 1, 2025

Язык: Английский

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Modifying Informed Consent to Help Address Functional Unmasking in Psychedelic Clinical Trials

JAMA Psychiatry, Год журнала: 2025, Номер 82(3), С. 311 - 311

Опубликована: Янв. 8, 2025

There is unprecedented clinician, industry, and patient interest in the therapeutic development of psychedelic drugs. This due to a combination promising clinical trial results, positive media coverage, lack novel pharmacologic treatments for psychiatric disorders recent decades. However, field faces key methodological challenge: masking participants treatment conditions trials has been largely unsuccessful. When can tell whether they received active drug or placebo, their responses assessments, questionnaires, even functional imaging biological data be influenced by preconceptions about effects. Positive expectancies combined with ineffective may skew outcomes inflate effect sizes. complicates efforts determine safety efficacy Here, we explore method help address this problem: modifying informed consent obscure information study design. We reviewed all contemporary (2000-2024) methylenedioxymethamphetamine (MDMA) therapy corresponded investigators compile on use modifications these studies. Modifying details design implemented several offer way strengthen masking. approach poses significant ethical risks. examine examples used literature, discuss current regulatory landscape, suggest strategies mitigate risks associated modified consent. Incorporating future improve interpretability impact, but not explicitly tested. Modifications appropriate cases, should minimized implementing guardrails.

Язык: Английский

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Expectancy Effects, Failure of Blinding Integrity, and Placebo Response in Trials of Treatments for Psychiatric Disorders

JAMA Psychiatry, Год журнала: 2025, Номер unknown

Опубликована: Март 12, 2025

Importance Expectancy effects are significant confounding factors in psychiatric randomized clinical trials (RCTs), potentially affecting the interpretation of study results. This narrative review is first, to our knowledge, explore relationship between expectancy effects, compromised blinding integrity, and active treatment/placebo RCTs. Additionally, we present statistical experimental approaches that may help mitigate impact effects. The concludes with recommendations enhance reliability RCTs psychiatry. Observations placebo response comprises both specific nonspecific elements, expectation being a key component. Evidence from studies suggests can influence treatment responses Blinding integrity be by perceived efficacy adverse introducing bias into outcome assessments. Treatment expectations lead unblinding during RCTs, meta-analytic data fields psychedelics anxiety disorders indicate this effect sizes. Therefore, controlling for essential when interpreting RCT Novel methods, though still need further validation, offer strategies address issue. Another approach involve medicine models, which aim develop objective improvement markers (readouts) less affected Conclusions Relevance represent confound We recommend collecting on alongside monitoring more accurately interpret developing readouts confounded offers another promising avenue mitigating these influences

Язык: Английский

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In the new era of psychedelic assisted therapy: A systematic review of study methodology in randomized controlled trials

Psychopharmacology, Год журнала: 2024, Номер 241(6), С. 1101 - 1110

Опубликована: Апрель 29, 2024

Язык: Английский

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Clinical and preclinical evidence of psilocybin as antidepressant. A narrative review

Progress in Neuro-Psychopharmacology and Biological Psychiatry, Год журнала: 2025, Номер unknown, С. 111249 - 111249

Опубликована: Янв. 1, 2025

Язык: Английский

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Embracing Epistemic Humility: Rethinking Psychedelic Exceptionalism Through Diverse Perspectives

The American Journal of Bioethics, Год журнала: 2025, Номер 25(1), С. 98 - 100

Опубликована: Янв. 2, 2025

Язык: Английский

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A Field-Wide Review and Analysis of Study Materials Used in Psilocybin Trials: Assessment of Two Decades of Research

Psychedelic Medicine, Год журнала: 2025, Номер unknown

Опубликована: Янв. 20, 2025

Язык: Английский

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Psychedelics and Suicide-Related Outcomes: A Systematic Review

Journal of Clinical Medicine, Год журнала: 2025, Номер 14(5), С. 1416 - 1416

Опубликована: Фев. 20, 2025

Background/Objectives: Suicide accounts for 1.4% of global deaths, and the slow-acting nature traditional treatments suicide risk underscores need alternatives. Psychedelic therapies may rapidly reduce risk. This systematic review evaluates impact psychedelic on suicide-related outcomes. Methods: A search MEDLINE, Embase, PsycINFO, ClinicalTrials.gov was conducted up to November 2024. Results: Four randomized controlled trials (RCTs) evaluated suicidality as a secondary outcome or safety measure, showing significant reductions in suicidal ideation with psilocybin (three studies) MDMA-assisted therapy (MDMA-AT; one study). Effect sizes, measured by Cohen’s d, ranged from =0.52 1.25 (p = 0.01 0.005), no issues reported. Five additional RCTs assessed (two MDMA-AT studies; p 0.02 0.04). Among 24 non-randomized cross-sectional studies, results were mixed. Psilocybin reduced ideation, odds ratios (OR) 0.40–0.75. (five studies PTSD patients) had pooled effect size d 0.61 (95% CI: 0.32–0.89). LSD (six showed increased suicidality, ranging 1.15 2.08. Studies involving DMT multiple psychedelics mixed results, not effects varying outcomes, some reporting others change. Conclusions: The outcomes remains inconclusive, highlighting further clarify therapeutic mechanisms.

Язык: Английский

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Psychedelic Use and Behavioral Addictions

Journal of Psychoactive Drugs, Год журнала: 2025, Номер unknown, С. 1 - 14

Опубликована: Март 15, 2025

Recent clinical trials on classic psychedelics for depression and anxiety have raised questions about their potential to treat other psychiatric conditions. Evidence from pre-clinical research suggests may help with substance use disorders, ongoing registered trials. Behavioral addictions, sharing features also respond psychedelic treatment. This study examined self-reported symptoms of problem gambling, sexual addiction, compulsive buying, eating disorders in a community sample (N = 1107), alongside measures well-being (self-transcendence, personal growth, depression/anxiety, etc.), psychoactive drugs. Significant positive correlations emerged among behavioral addiction symptoms, inverse between addictions. Psychedelic users reported greater lower even after controlling demographics drug use. Principal components analysis showed that addictions formed single factor, which was combined into composite score. Multiple regression analyses revealed major stimulant, alcohol, nicotine vaping predicted higher scores, while uniquely scores. These findings suggest aid treating A controlled pilot or trial is warranted explore this therapeutic further.

Язык: Английский

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«Psychedelics, OCD and Related Disorders: Setting Methodological Strategies for Future Studies»

Journal of Obsessive-Compulsive and Related Disorders, Год журнала: 2025, Номер unknown, С. 100951 - 100951

Опубликована: Март 1, 2025

Язык: Английский

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