Effects of Salvinorin A on Brain Function
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have given written informed consent
- Have a high school level of education
- Have a history of hallucinogen use and experience with an inhaled psychoactive drug.
- Recent experience (within the past year) with an inhaled psychoactive drug.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not usually consume caffeinated beverages, he or she must agree not to do so on session days
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and any tobacco product such as cigarettes or any other nicotine product such as e-cigarettes, within 24 hours of each drug administration. Exceptions include daily use of caffeine.
- Be healthy and psychologically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, and routine medical blood and urinalysis laboratory tests
- Agree that for one week before each session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except if approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals
- Agree not to take any Pro-re-nata (PRN) prescription medications on the mornings of the sessions
Exclusion Criteria:
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, or Transient Ischemic Attack (TIA) in the past year
- Seizure disorder or epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Currently taking psychoactive prescription medication on a regular (e.g., daily) basis
- More than 25% outside the upper or lower range of ideal body weight
- Current or past history of meeting Diagnostic and Statistical Manual (DSM)-V criteria for schizophrenia, psychotic disorder (unless substance-induced or due to a medical condition), dissociative disorder, bipolar I or II disorder, an eating disorder
- Current or past history of substance-induced psychosis.
- Current or past history within the last 2 years of meeting DSM-5 criteria for moderate or severe alcohol or substance use disorder (excluding caffeine)
- Daily or more frequent tobacco or nicotine use
- Current severe obsessive-compulsive disorder, dysthymic disorder, or panic disorder.
- Current, severe, major depression
- Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder
- Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to salvinorin A
- Head trauma, traumatic brain injury, or concussion with loss of consciousness for >2 minutes
- Claustrophobia incompatible with MRI scanning
- Medical device incompatible with MRI scanning (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant)
- Prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan
- Left-handedness (assessed by the Edinburgh Handedness Inventory)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Salvinorin A administration
All volunteers will be assigned to the salvinorin A administration arm.
|
Salvinorin A, blinded doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre salvinorin A administration and 20 minutes post-salvinorin A administration
|
|
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).
|
Pre-salvinorin A administration and 20 minutes post-salvinorin A administration
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Frederick S Barrett, Ph.D., Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB00131537
- 5R01DA003889-31 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Drug Effect
-
NCT03887247Active, not recruitingAdverse Drug Effect of Opioids | Adverse Drug Effect of Benzodiazepines
-
NCT03922451Terminated
-
NCT05050071Completed
-
NCT04037774Unknown
-
NCT03593408Recruiting
-
NCT05926570Completed
-
NCT05686863Completed
-
NCT03787550Unknown
Clinical Trials on Salvinorin A
-
NCT01149824CompletedPharmaceutical Preparations
-
NCT04289103Not yet recruiting
-
NCT01437319CompletedCorneal Infiltrative Events | Corneal Inflammation
-
NCT02637804Completed