Effects of Salvinorin A on Brain Function
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|ClinicalTrials.gov Identifier: NCT03418714|
Recruitment Status : Completed
First Posted : February 1, 2018
Results First Posted : March 4, 2021
Last Update Posted : March 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Drug Effect||Drug: Salvinorin A||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Participants will not be aware of exact doses salvinorin A (i.e. they will be told they may receive placebo or up to a moderately high dose of of salvinorin A).|
|Official Title:||Effects of Salvinorin A on Brain Function|
|Actual Study Start Date :||December 14, 2017|
|Actual Primary Completion Date :||March 2, 2020|
|Actual Study Completion Date :||March 2, 2020|
Experimental: Salvinorin A administration
All volunteers will be assigned to the salvinorin A administration arm.
Drug: Salvinorin A
Salvinorin A, blinded doses
Other Name: salvia, salvia divinorum
- Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal [ Time Frame: Pre salvinorin A administration and 20 minutes post-salvinorin A administration ]Changes in brain activity from before to after salvinorin A administration within canonical brain networks [medial frontal (MF), frontoparietal (FP), default mode (DM), subcortical-cerebellum (SubC), somatosensory-motor (SM), medial visual (MedV), occipital pole (OccP), and lateral visual or (LatV)] will be assessed using blood-oxygenation level dependent (BOLD) techniques. Due to salvinorin A's potential confounding influence on blood flow, activity was assessed by looking at the variance in the BOLD signal. Variance in BOLD signal is a dimensionless variable that can vary from 0 to infinity.
- Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation [ Time Frame: Pre-salvinorin A administration and 20 minutes post-salvinorin A administration ]Changes in within and between network functional connectivity (FC) from pre to post-salvinorin A (SA) administration in several brain networks [medial frontal (MF), frontoparietal (FP), default mode (DM), subcortical-cerebellum (SubC), somatosensory-motor (SM), medial visual (MedV), occipital pole (OccP), lateral visual or (LatV)] is assessed via analysis of blood-oxygenation level dependent (BOLD) data. FC is the association between the BOLD activity of two regions over time. This is measured with a Pearson's correlation that is made parametric via z-transformation. FC within a network is the average of all possible pairwise combinations of z-transformed correlations within a network. FC between two networks is the average of all possible pairwise combinations of z-transformed correlations between two networks. We looked at the change in FC from pre to post-SA averaged across participants (this also gives a measure of dispersion).
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): NCT03418714
|United States, Maryland|
|Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Frederick S Barrett, Ph.D.||Johns Hopkins University|