Psilocybin-facilitated Treatment for Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05068791|
Recruitment Status : Not yet recruiting
First Posted : October 6, 2021
Last Update Posted : October 3, 2022
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia, Primary||Drug: Psilocybin Drug: Dextromethorphan||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a double-blind, placebo- controlled clinical trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Psilocybin-facilitated Treatment for Chronic Pain|
|Estimated Study Start Date :||January 2023|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2024|
Participants in the Psilocybin condition will receive .36 mg/kg of psilocybin.
0.36 mg/kg will be administered orally to participants
Active Comparator: Active Placebo
Participants in the Active Placebo condition will receive 2.6 mg/kg of dextromethorphan (DXM).
2.6 mg/kg of active placebo will be administered orally to participants
- Change in daily self-reported pain severity [ Time Frame: through study completion, up to 13 weeks ]Daily pain severity will be measured using a visual analog scale rated from 0 ('no pain at all') to 100 ('severe pain')
- Patient Global Impression of Change (PGIC) [ Time Frame: through study completion, up to 13 weeks ]The PGIC is a single-item Likert scale with seven response options from 1 ('very much improved') to 7 ('very much worse').
- Change in self-reported pain severity (Brief Pain Inventory [BPI]) [ Time Frame: through study completion, up to 13 weeks ]Pain severity scores will be calculated as a composite of the four pain severity items scored from 0 ('no pain') to 10 ('pain as bad as you can imagine') on the BPI
- Change in self-reported pain interference (Brief Pain Inventory [BPI]) [ Time Frame: through study completion, up to 13 weeks ]Pain interference scores will be calculated as the mean of the seven pain interference items scored from 0 ('does not interfere') to 10 ('completely interferes') on the BPI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068791
|Contact: Peter Hendricks, Ph.D.||firstname.lastname@example.org|
|Contact: Kathleen Hodgin, M.A.||email@example.com|