Trial Outcomes & Findings for Effects of Salvinorin A on Brain Function (NCT NCT03418714)
NCT ID: NCT03418714
Last Updated: 2021-03-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Pre salvinorin A administration and 20 minutes post-salvinorin A administration
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
Salvinorin A Administration
All volunteers will be assigned to the salvinorin A administration arm.
Salvinorin A: Salvinorin A (15 micrograms/kg, vaporized), blinded doses
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Salvinorin A on Brain Function
Baseline characteristics by cohort
| Measure |
Salvinorin A Administration
n=13 Participants
All volunteers will be assigned to the salvinorin A administration arm.
Salvinorin A: Salvinorin A, blinded doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.46 years
STANDARD_DEVIATION 8.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
|
Lifetime uses of Salvia divinorum
|
22.08 number of times
STANDARD_DEVIATION 48.70 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre salvinorin A administration and 20 minutes post-salvinorin A administrationChanges 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.
Outcome measures
| Measure |
Salvinorin A Administration
n=12 Participants
All volunteers will be assigned to the salvinorin A administration arm.
Salvinorin A: Salvinorin A, blinded doses
|
|---|---|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
MF activity
|
15.65 variance in BOLD signal
Standard Deviation 74.38
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
FP activity
|
18.06 variance in BOLD signal
Standard Deviation 117.54
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
DM activity
|
23.39 variance in BOLD signal
Standard Deviation 229.30
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
SubC activity
|
8.93 variance in BOLD signal
Standard Deviation 40.91
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
SM activity
|
13.06 variance in BOLD signal
Standard Deviation 79.58
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
MedV activity
|
26.15 variance in BOLD signal
Standard Deviation 406.07
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
OccP activity
|
16.96 variance in BOLD signal
Standard Deviation 366.90
|
|
Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
LatV activity
|
9.30 variance in BOLD signal
Standard Deviation 77.47
|
PRIMARY outcome
Timeframe: Pre-salvinorin A administration and 20 minutes post-salvinorin A administrationChanges 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).
Outcome measures
| Measure |
Salvinorin A Administration
n=12 Participants
All volunteers will be assigned to the salvinorin A administration arm.
Salvinorin A: Salvinorin A, blinded doses
|
|---|---|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SubC within-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .03
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SM within-network connectivity
|
.05 Z-transformed Pearson's correlation
Standard Deviation .09
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-OccP between-network connectivity
|
.05 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-SubC between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .03
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-MedV between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .07
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-LatV between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .05
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM-SubC between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .03
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM-MedV between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM-OccP between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .09
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM-LatV between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF within-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP within-network connectivity
|
.05 Z-transformed Pearson's correlation
Standard Deviation .07
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM within-network connectivity
|
.09 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MedV within-network connectivity
|
.06 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
OccP within-network connectivity
|
.05 Z-transformed Pearson's correlation
Standard Deviation .09
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
LatV within-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .08
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-FP between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .08
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-DM between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .09
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-SubC between-network connectivity
|
.00 Z-transformed Pearson's correlation
Standard Deviation .03
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-SM between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .09
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-MedV between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .08
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MF-LatV between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-DM between-network connectivity
|
.03 Z-transformed Pearson's correlation
Standard Deviation .05
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-SM between-network connectivity
|
.03 Z-transformed Pearson's correlation
Standard Deviation .08
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
FP-OccP between-network connectivity
|
.04 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
DM-SM between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .06
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SubC-SM between-network connectivity
|
.00 Z-transformed Pearson's correlation
Standard Deviation .03
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SubC-MedV between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .05
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SubC-OccP between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .05
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SubC-LatV between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .04
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SM-MedV between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .12
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SM-OccP between-network connectivity
|
.04 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
SM-LatV between-network connectivity
|
.01 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MedV-OccP between-network connectivity
|
.02 Z-transformed Pearson's correlation
Standard Deviation .14
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
MedV-LatV between-network connectivity
|
.06 Z-transformed Pearson's correlation
Standard Deviation .10
|
|
Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
OccP-LatV between-network connectivity
|
.03 Z-transformed Pearson's correlation
Standard Deviation .11
|
Adverse Events
Salvinorin A Administration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place