Dataset Information

Psychosis-Relevant Effects of Intravenous Delta-9-Tetrahydrocannabinol: A Mega Analysis of Individual Participant-Data from Human Laboratory Studies.

ABSTRACT: Introduction: There is increasing interest in the relationship between cannabinoids and psychosis. While individual human laboratory studies have been critical in demonstrating that cannabinoids (e.g., delta-9-tetrahydrocannabinol [THC]) can induce acute transient psychosis-like effects in healthy human volunteers, combining data from multiple studies offers a fine-grained view of these effects.

Methods: THC-induced psychosis-relevant effects were examined using a data repository of 10 double-blind, randomized, placebo-controlled, crossover studies with 400 i.v. THC infusions in healthy human volunteers. The Positive and Negative Syndrome scale was used to measure psychotomimetic effects. The profile of symptoms, frequency of a response, its relationship to THC dose and substance use, latent structure in Positive and Negative Syndrome scale response, and the relationships between psychotomimetic and perceptual alteration symptoms were evaluated.

Results: Clinically meaningful increases in positive symptoms were noted in 44.75% infusions; conceptual disorganization, hallucinations, blunted affect, somatic concern, motor retardation, and poor attention were the items most frequently altered by THC. The increase in Positive and Negative Syndrome scale positive symptoms was positively associated with THC dose (beta?=?11.13, SE?=?4.94, Wald ??2?=?19.88, P?
Conclusion: Intravenous administration of THC consistently induces psychotomimetic effects that include symptoms across Positive and Negative Syndrome scale domains. Moreover, healthy individuals who frequently use cannabis have a blunted psychotomimetic response.

SUBMITTER: Ganesh S

PROVIDER: S-EPMC7710917 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Psychosis-Relevant Effects of Intravenous Delta-9-Tetrahydrocannabinol: A Mega Analysis of Individual Participant-Data from Human Laboratory Studies.

Ganesh Suhas S Cortes-Briones Jose J Ranganathan Mohini M Radhakrishnan Rajiv R Skosnik Patrick D PD D'Souza Deepak Cyril DC

The international journal of neuropsychopharmacology 20201201 9

<h4>Introduction</h4>There is increasing interest in the relationship between cannabinoids and psychosis. While individual human laboratory studies have been critical in demonstrating that cannabinoids (e.g., delta-9-tetrahydrocannabinol [THC]) can induce acute transient psychosis-like effects in healthy human volunteers, combining data from multiple studies offers a fine-grained view of these effects.<h4>Methods</h4>THC-induced psychosis-relevant effects were examined using a data repository of ...[more]

PMID: 32385508

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Project description:BACKGROUND:Data repositories have the potential to play an important role in the effective and safe sharing of individual-participant data (IPD) from clinical studies. We analysed the current landscape of data repositories to create a detailed description of available repositories and assess their suitability for hosting data from clinical studies, from the perspective of the clinical researcher. METHODS:We assessed repositories that enable storage, sharing, discoverability, re-use of the IPD and associated documents from clinical studies using a pre-defined set of 34 items and publicly available information from April to June 2018. For this purpose, we developed an indicator set to capture the maturity of the repositories' procedures and their suitability for the hosting of IPD. The indicators cover guidelines for data upload and data de-identification, data quality controls, contracts for upload and storage, flexibility of access, application of identifiers, availability of metadata, and long-term preservation. RESULTS:We analysed 25 repositories, from an initial set of 55 identified as possibly relevant. Half of the included repositories were generic, i.e. not limited to a specific disease or clinical area and 13 were launched in the last 8 years. The sample was extremely heterogeneous and included repositories developed by research funders, infrastructures, universities, and editors. All but three repositories do not apply a fee for uploading, storage or access to data. None of the repositories completely demonstrated all the items included in the indicator set, but three repositories (Dryad, Drum, EASY) met - fully or partially - all items. Flexibility of data-access modalities appears to be limited, being lacking in half of the repositories. CONCLUSIONS:Our evaluation, though often hampered by the lack of sufficient information, can help researchers to find a suitable repository for their datasets. Some repositories are more mature because of their support for clinical dataset preparation, contractual agreements, metadata and identifiers, different modalities of access, and long-term preservation of data. Further work is now required to achieve a more robust and accurate system for evaluation, which in turn may encourage the sharing of clinical study data. TRIAL REGISTRATION:Study protocol available at https://zenodo.org/record/1438261#.W64kW9Egrcs .

Dataset Information

Psychosis-Relevant Effects of Intravenous Delta-9-Tetrahydrocannabinol: A Mega Analysis of Individual Participant-Data from Human Laboratory Studies.

Publications

Psychosis-Relevant Effects of Intravenous Delta-9-Tetrahydrocannabinol: A Mega Analysis of Individual Participant-Data from Human Laboratory Studies.

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