Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626139
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
2 X 2 Factorial Double-blind Randomized Trial of set and Setting a Translational Study in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
SnS
Brief Summary:
One hundred twenty healthy participants ages 21 to 70 who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms using a 2x2 factorial design Depending on the study arm participants will either receive an inactive placebo or up to 25mg psilocybin oral dose in one of two set and setting conditions drug administration contexts that are predicted to modulate drug effects
The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context set and setting
The purpose of this study is to evaluate any interaction effects between an oral dose of psilocybin and the surrounding context set and setting
Detailed Description:
Recent research posits that psychedelic medicine is best employed as a combination treatment ie as drug x psychological support or psychotherapy referred to for simplicity as psychedelic therapy It is assumed that positive outcomes via psychedelic therapy critically depend on a synergistic relationship between drug-induced brain and mind plasticity and supportive contextual factors Carhart-Harris et al 2018 Carhart-Harris and Friston 2019 These contextual factors have been referred to as set and setting Leary et al 1963 or extrapharmacological- highlighting elements beyond the drug that contribute to relevant outcomes Hartogsohn 2016
The proposed experiment is a double-blind randomized between-subjects 2 x 2 factorial study in 120 volunteers who experience low psychological well-being at baseline and have limited prior experience with psychedelics 1111 n 30 per condition The main aim of the study is to assess the contribution of a select number of pre-defined contextual variables both set and setting on the nature and trajectory of effects linked to a single dosing session with either psilocybin oral 25mg or placebo oral inert
The study will have four primary outcomes two pertaining to mental health namely changes in psychological well-being - as measured via the Warwick-Edinburgh Mental Wellbeing Scales WEMWBS from baseline to 4 weeks post dosing session primary endpoint and changes in the Watts Connectedness Scale WCS at consistent timepoints The two primary outcomes indexing the quality of the acute experience will be Emotional Breakthrough - measured via mean scores on the Emotional Breakthrough Inventory EBI and Challenging experience CE - defined and measured here as scores on the following four sub-factors of the Challenging Experience Questionnaire CEQ fear insanity isolation and paranoia
The proposed experiment is a double-blind randomized between-subjects 2 x 2 factorial study in 120 volunteers who experience low psychological well-being at baseline and have limited prior experience with psychedelics 1111 n 30 per condition The main aim of the study is to assess the contribution of a select number of pre-defined contextual variables both set and setting on the nature and trajectory of effects linked to a single dosing session with either psilocybin oral 25mg or placebo oral inert
The study will have four primary outcomes two pertaining to mental health namely changes in psychological well-being - as measured via the Warwick-Edinburgh Mental Wellbeing Scales WEMWBS from baseline to 4 weeks post dosing session primary endpoint and changes in the Watts Connectedness Scale WCS at consistent timepoints The two primary outcomes indexing the quality of the acute experience will be Emotional Breakthrough - measured via mean scores on the Emotional Breakthrough Inventory EBI and Challenging experience CE - defined and measured here as scores on the following four sub-factors of the Challenging Experience Questionnaire CEQ fear insanity isolation and paranoia
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