Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry

TY - JOUR

T1 - Assessment of clinical outcomes in patients with post-traumatic stress disorder

T2 - analysis from the UK Medical Cannabis Registry

AU - Pillai, Manaswini

AU - Erridge, Simon

AU - Bapir, Lara

AU - Nicholas, Martha

AU - Dalavaye, Nishaanth

AU - Holvey, Carl

AU - Coomber, Ross

AU - Barros, Daniela

AU - Bhoskar, Urmila

AU - Mwimba, Gracia

AU - Praveen, Kavita

AU - Symeon, Chris

AU - Sachdeva-Mohan, Simmi

AU - Rucker, James J.

AU - Sodergren, Mikael H.

N1 - Funding Information: S Erridge, C Holvey, R Coomber, JJ Rucker, and MH Sodergren are the founding clinicians of Sapphire Medical Clinics, which is the first clinic registered with the CQC to evaluate patients for medical cannabis in England. R Coomber and MH Sodergren are directors at Sapphire Medical Clinics. S Erridge undertakes paid consultancy work at Sapphire Medical Clinics. C Holvey, D Barros, U Bhoskar, G Mwimba, K Praveen, C Symeon, S Sachdeva-Mohan, and JJ Rucker are employees of Sapphire Medical Clinics. MH Sodergren is also Chief Medical Officer at Curaleaf International. JJ Rucker is funded by a fellowship (CS-2017-17-007) from the National Institute for Health Research (NIHR). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Publisher Copyright: © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

PY - 2022/12/12

Y1 - 2022/12/12

N2 - Background: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. Methods: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. Results: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00–70.00) mg of cannabidiol and 145.00 (IQR: 100.00–200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). Conclusions: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.

AB - Background: The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD. Methods: A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050. Results: Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00–70.00) mg of cannabidiol and 145.00 (IQR: 100.00–200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%). Conclusions: Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.

KW - Cannabidiol

KW - medical cannabis

KW - post-traumatic stress disorder

KW - PTSD

KW - tetrahydrocannabinol

UR - http://www.scopus.com/inward/record.url?scp=85144135849&partnerID=8YFLogxK

U2 - 10.1080/14737175.2022.2155139

DO - 10.1080/14737175.2022.2155139

M3 - Article

C2 - 36503404

AN - SCOPUS:85144135849

SN - 1473-7175

VL - 22

SP - 1009

EP - 1018

JO - Expert Review of Neurotherapeutics

JF - Expert Review of Neurotherapeutics

IS - 11-12

ER -