Psilocybin in Cancer Pain Study (NCT06001749) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin in Cancer Pain Study
United States15 participantsStarted 2024-09-23
Plain-language summary
The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer.
The name of the study intervention used in this research study is:
Psilocybin (a tryptamine derivative)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must be 18 year old or older;
* Participants must have advanced cancer, defined as a cancer that is unlikely to be cured or controlled with treatment;
* Participants must have progressed on or be intolerant to approved therapies with a known clinical benefit (unless it is documented that they have refused such treatments);
* Participants must evaluate their average pain on BPI Severity Scale ≥ 4/10 over the past week;
* Participants must receive chronic opioid pharmacotherapy for pain with an Oral Morphine Equivalent (OME) ≥ 200mg/day;
* Participants must have been seen by a palliative care clinician either at DFCI, MGH or associated satellites in the last three months;
* Participants must have an ECOG Performance Status ≤ 2
* Participants must meet the following organ and marrow function on their last available bloodwork as defined below:
* Platelets ≥ 50,000/mcL
* AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN
* Participants must be able to understand and willing to sign a written informed consent document
* Participants must be able to swallow pills.
* Participants must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
* Participants must agree to inform the investigators within 48 hours of any new medical conditions and procedures.
* Participants must agree to the following lifestyle modif…