News Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review

[S.J.B.]

Patient safety issues halt trial for MDMA-assisted psychotherapy during Health Canada review
Bethany Lindsay
CBC
July 18th, 2022

Excerpt:

Patient safety concerns uncovered during an ongoing federal review have led to the suspension of one of two clinical trials for MDMA-assisted psychotherapy currently underway in Canada.

The Phase II trial in Toronto, sponsored by a mental health charity called the Remedy Institute, was issued a non-compliant rating on June 22, according to Health Canada.

A spokesperson told CBC in an email that the study was put on hold "due to concerns for participant safety."

The federal regulator's summary of a June 6 inspection identifies 12 concerns with the project, including a failure to conduct the study according to the approved protocol, problems with quality control and staff training, and a lack of informed written consent from participants.

The report card also says that medical care for the patients involved was happening without supervision from a qualified investigator.

 

[thegreenhand]

Direct quotations of some of the findings from the Clinical trial inspection report card summary:

“The sponsor did not implement systems and procedures to ensure the required information was submitted to the Research Ethics Board.”

“The sponsor did not get written informed consent for every person before they participated in the clinical trial or the amended clinical trial.”

“The sponsor did not implement systems and procedures to ensure the quality of the clinical trial.”

There are more but those ones are the most striking to me. Last century, psychedelic research was ended by moralist propaganda. This time, it might be from the researchers’ own hands. Nice job everybody lol

 

[Landrew]

What interests me is the silence. No mention on MSM I can find outside of CBCs article.