Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512194
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Investigation to Understand and Optimize Psilocybin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin The OPTIMIZE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMIZE
Brief Summary:
This study will examine whether the antidepressant effect of a single dose of psilocybin administered with psychological support can be increased and extended via the use of post-dosing transcutaneous auricular Vagus Nerve Stimulation taVNS a known inducer of neuroplastic brain processes believed to be involved in the therapeutic effects of psilocybin In addition the study will examine objectively measured aspects of real-world social behavior known to promote wellbeing Finally the study will explore strategies for improving our ability to identify pre-treatment or early post-treatment behavioral responses to psilocybin predictive of good and bad longer-term therapeutic outcomes
Detailed Description:
One hundred forty-one adults ages 18 to 70 experiencing a major depressive episode of at least 60 days duration of moderate or greater severity at screening as indexed by a Montgomery-Asperg Depression Rating Scale MADRS score at screening 28 will be enrolled to obtain evaluable data on approximately 120 subjects
All subjects will receive a single 25 mg dose of psilocybin using a set and setting therapeutic approach that will include 1 several hours of preparatory sessions prior to dosing and 2 the presence of two facilitators throughout the dosing session and 3 several post dosing integration sessions with a facilitator Following the psilocybin dosing session subjects will be randomized with a 1-to-1-to-1 allocation to 1 7 days of twice daily transcutaneous auricular Vagus Nerve Stimulation taVNS vs 2 7 days of twice daily sham taVNS vs 3 treatment as usual TAU comprised of 3 post-psilocybin dosing integration sessions Of note because the provision of post-dosing integration sessions is current standard of care for psychedelic assisted therapy subjects randomized to taVNS or sham will also receive 3 post dosing integration sessions in keeping with the studys goal of evaluating whether TAU can be enhanced by the addition of taVNS Both taVNS and sham sessions will be paired with prompts for subjects to focus on key elements of their psychedelic experiences and with selections of music used during the psilocybin dosing session This pairing approach is consistent with data demonstrating that the effect of taVNS is maximized when the procedure is used in conjunction with contextual cues relevant to the sought behavioral change
Assessments throughout study participation will assess depression anxiety well-being functional disability quality of life social behavior suicidal ideation and adverse events prior to and post-psilocybin dosing
All subjects will receive a single 25 mg dose of psilocybin using a set and setting therapeutic approach that will include 1 several hours of preparatory sessions prior to dosing and 2 the presence of two facilitators throughout the dosing session and 3 several post dosing integration sessions with a facilitator Following the psilocybin dosing session subjects will be randomized with a 1-to-1-to-1 allocation to 1 7 days of twice daily transcutaneous auricular Vagus Nerve Stimulation taVNS vs 2 7 days of twice daily sham taVNS vs 3 treatment as usual TAU comprised of 3 post-psilocybin dosing integration sessions Of note because the provision of post-dosing integration sessions is current standard of care for psychedelic assisted therapy subjects randomized to taVNS or sham will also receive 3 post dosing integration sessions in keeping with the studys goal of evaluating whether TAU can be enhanced by the addition of taVNS Both taVNS and sham sessions will be paired with prompts for subjects to focus on key elements of their psychedelic experiences and with selections of music used during the psilocybin dosing session This pairing approach is consistent with data demonstrating that the effect of taVNS is maximized when the procedure is used in conjunction with contextual cues relevant to the sought behavioral change
Assessments throughout study participation will assess depression anxiety well-being functional disability quality of life social behavior suicidal ideation and adverse events prior to and post-psilocybin dosing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None