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Record W4387674199 · doi:10.1089/psymed.2023.0028

A Systematic Review of Study Design and Placebo Controls in Psychedelic Research

2023· review· en· W4387674199 on OpenAlexafffund
Alexander Wen, Nikhita Singhal, Brett D. M. Jones, Richard J. Zeifman, Shobha Mehta, Mohammad Ali Shenasa, Daniel M. Blumberger, Zafiris J. Daskalakis, Cory R. Weissman

Bibliographic record

VenuePsychedelic Medicine · 2023
Typereview
Languageen
FieldPsychology
TopicPsychedelics and Drug Studies
Canadian institutionsCentre for Addiction and Mental HealthUniversity of Toronto
FundersNational Institute of Mental HealthCanadian Institutes of Health ResearchAgricultural Technology Adoption InitiativeNational Institutes of HealthBrainsWayCentre for Addiction and Mental Health FoundationFondation Brain Canada
KeywordsPlaceboResearch designSystematic reviewPsychologyMedicineAlternative medicineMEDLINESociologyPolitical sciencePathologySocial science

Abstract

fetched live from OpenAlex

Introduction: Effective blinding is especially challenging in randomized controlled trials (RCTs) involving psychedelics due to the inherent alterations in consciousness that these compounds induce. In this systematic review and exploratory analysis, we aim at synthesizing the methodologies used in RCTs involving classic psychedelics and identify procedures that can help minimize unblinding and bias. Methods: We completed a literature search that included prospective RCTs published between 1963 and January 2023, in which participants were randomized to receive either a classic psychedelic or placebo. Results: A total of 1402 papers were included in the initial search. After eligibility criteria were applied, 50 papers from 48 clinical trials were included. Most studies were double blinded ( n = 34), used a within-subjects design ( n = 32 studies), and included inert placebos ( n = 35). The majority of studies did not report on the integrity of blinding procedures ( n = 34 studies); however, in studies that did, blinding was unsuccessful. Conclusion: To improve blinding and lower expectancy effects, we suggest incorporating active placebos and utilizing dose response or active comparator study designs.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.030
metaresearch head score (Gemma)0.005
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch, Meta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Systematic review · Consensus signal: Systematic review
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.025
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0300.005
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0110.000
Bibliometrics0.0020.004
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0010.000
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0000.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.513
GPT teacher head0.592
Teacher spread0.078 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designSystematic review
Domainnot available
GenreReview

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations33
Published2023
Admission routes2
Has abstractyes

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