Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Salvinorin A on Brain Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03418714
Recruitment Status : Completed
First Posted : February 1, 2018
Results First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Drug Effect
Intervention Drug: Salvinorin A
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Salvinorin A Administration
Hide Arm/Group Description

All volunteers will be assigned to the salvinorin A administration arm.

Salvinorin A: Salvinorin A (15 micrograms/kg, vaporized), blinded doses

Period Title: Overall Study
Started 13
Completed 12 [1]
Not Completed 1
[1]
One participant moved too much during the practice session and was therefore excluded from the scan.
Arm/Group Title Salvinorin A Administration
Hide Arm/Group Description

All volunteers will be assigned to the salvinorin A administration arm.

Salvinorin A: Salvinorin A, blinded doses

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
35.46  (8.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
1
   7.7%
Male
12
  92.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
12
  92.3%
Unknown or Not Reported
1
   7.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   7.7%
White
11
  84.6%
More than one race
0
   0.0%
Unknown or Not Reported
1
   7.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
 100.0%
Lifetime uses of Salvia divinorum   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of times
Number Analyzed 13 participants
22.08  (48.70)
[1]
Measure Description: Number of times Salvia divinorum (plant containing salvinorin A) had been used prior to participating in the study.
1.Primary Outcome
Title Changes in Brain Activity (fMRI) as Assessed by Variance in BOLD Signal
Hide Description 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.
Time Frame Pre salvinorin A administration and 20 minutes post-salvinorin A administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salvinorin A Administration
Hide Arm/Group Description:

All volunteers will be assigned to the salvinorin A administration arm.

Salvinorin A: Salvinorin A, blinded doses

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: variance in BOLD signal
MF activity 15.65  (74.38)
FP activity 18.06  (117.54)
DM activity 23.39  (229.30)
SubC activity 8.93  (40.91)
SM activity 13.06  (79.58)
MedV activity 26.15  (406.07)
OccP activity 16.96  (366.90)
LatV activity 9.30  (77.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salvinorin A Administration
Comments T test on the change in network activity across all networks, from before to after salvinorin A administration.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Changes in Brain Connectivity (fMRI) as Assessed by Pearson's Correlation
Hide Description 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).
Time Frame Pre-salvinorin A administration and 20 minutes post-salvinorin A administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salvinorin A Administration
Hide Arm/Group Description:

All volunteers will be assigned to the salvinorin A administration arm.

Salvinorin A: Salvinorin A, blinded doses

Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Z-transformed Pearson's correlation
MF within-network connectivity .01  (.10)
FP within-network connectivity .05  (.07)
DM within-network connectivity .09  (.06)
SubC within-network connectivity .01  (.03)
SM within-network connectivity .05  (.09)
MedV within-network connectivity .06  (.10)
OccP within-network connectivity .05  (.09)
LatV within-network connectivity .02  (.08)
MF-FP between-network connectivity .02  (.08)
MF-DM between-network connectivity .02  (.09)
MF-SubC between-network connectivity .00  (.03)
MF-SM between-network connectivity .01  (.09)
MF-MedV between-network connectivity .01  (.08)
MF-OccP between-network connectivity .05  (.10)
MF-LatV between-network connectivity .01  (.06)
FP-DM between-network connectivity .03  (.05)
FP-SubC between-network connectivity .01  (.03)
FP-SM between-network connectivity .03  (.08)
FP-MedV between-network connectivity .01  (.07)
FP-OccP between-network connectivity .04  (.06)
FP-LatV between-network connectivity .02  (.05)
DM-SubC between-network connectivity .01  (.03)
DM-SM between-network connectivity .02  (.06)
DM-MedV between-network connectivity .02  (.06)
DM-OccP between-network connectivity .02  (.09)
DM-LatV between-network connectivity .02  (.06)
SubC-SM between-network connectivity .00  (.03)
SubC-MedV between-network connectivity .02  (.05)
SubC-OccP between-network connectivity .01  (.05)
SubC-LatV between-network connectivity .01  (.04)
SM-MedV between-network connectivity .02  (.12)
SM-OccP between-network connectivity .04  (.10)
SM-LatV between-network connectivity .01  (.10)
MedV-OccP between-network connectivity .02  (.14)
MedV-LatV between-network connectivity .06  (.10)
OccP-LatV between-network connectivity .03  (.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salvinorin A Administration
Comments T test on the change in within- and between-network connectivity across all values, from before to after salvinorin A administration.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Salvinorin A Administration
Hide Arm/Group Description

All volunteers will be assigned to the salvinorin A administration arm.

Salvinorin A: Salvinorin A, blinded doses

All-Cause Mortality
Salvinorin A Administration
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Serious Adverse Events
Salvinorin A Administration
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Salvinorin A Administration
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frederick Barrett
Organization: Johns Hopkins University
Phone: 4105509777
EMail: fbarret2@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03418714    
Other Study ID Numbers: IRB00131537
5R01DA003889-31 ( U.S. NIH Grant/Contract )
First Submitted: January 26, 2018
First Posted: February 1, 2018
Results First Submitted: January 22, 2021
Results First Posted: March 4, 2021
Last Update Posted: March 4, 2021