NCT03418714

Effects of Salvinorin A on Brain Function

Completed Phase 1, PHASE2 Results posted Last updated 4 March 2021

What this trial tests

Phase 1, PHASE2 trial testing Salvinorin A in Drug Effect in 13 participants. Completed in 2 March 2020.

Timeline

14 December 2017

Primary endpoint
2 March 2020

2 March 2020

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	13
Start date	14 December 2017
Primary completion	2 March 2020
Estimated completion	2 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Salvinorin A — full drug profile →

Conditions studied

• Drug Effect — all drugs for Drug Effect →

Sponsor

Johns Hopkins University

Who can join

Adults 21 to 50, any sex, with Drug Effect. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal Primary · 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 infinit

MF activity

Group	Value	95% CI
Salvinorin A Administration	15.65	± 74.38

FP activity

Group	Value	95% CI
Salvinorin A Administration	18.06	± 117.54

DM activity

Group	Value	95% CI
Salvinorin A Administration	23.39	± 229.30

SubC activity

Group	Value	95% CI
Salvinorin A Administration	8.93	± 40.91

SM activity

Group	Value	95% CI
Salvinorin A Administration	13.06	± 79.58

MedV activity

Group	Value	95% CI
Salvinorin A Administration	26.15	± 406.07

OccP activity

Group	Value	95% CI
Salvinorin A Administration	16.96	± 366.90

LatV activity

Group	Value	95% CI
Salvinorin A Administration	9.30	± 77.47

Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation Primary · 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 t

MF within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.01	± .10

FP within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.05	± .07

DM within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.09	± .06

SubC within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.01	± .03

SM within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.05	± .09

MedV within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.06	± .10

OccP within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.05	± .09

LatV within-network connectivity

Group	Value	95% CI
Salvinorin A Administration	.02	± .08

Sponsor's own description

This study will investigate the effects of salvinorin A on human brain activity and connectivity using functional magnetic resonance imaging (fMRI) methods. An inhalation route of administration will be used as it is the most common route for contemporary use of Salvia divinorum, a plant containing salvinorin A.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Kappa Opioid Receptor: A Promising Therapeutic Target for Multiple Pathologies.
   Dalefield ML, Scouller B, Bibi R, Kivell BM. · · 2022 · cited 70× · PMID 35795569 · DOI 10.3389/fphar.2022.837671
2. The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
   Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167