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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE January 26, 2018
First Posted Date  ICMJE February 1, 2018
Results First Submitted Date  ICMJE January 22, 2021
Results First Posted Date  ICMJE March 4, 2021
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE December 14, 2017
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 26, 2018)
  • Changes in brain activity (fMRI) [ Time Frame: Continuous for 20 minutes after drug administration ]
    Changes in brain activity will be assessed using blood-oxygenation level dependent [BOLD] techniques.
  • Changes in brain connectivity (fMRI) [ Time Frame: Continuous for 20 minutes after drug administration ]
    Changes in within- and between-network connectivity strength of several brain networks will be assessed via analysis of blood-oxygenation level dependent [BOLD] data.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Salvinorin A on Brain Function
Official Title  ICMJE Effects of Salvinorin A on Brain Function
Brief Summary 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.
Detailed Description Volunteers will undergo two experimental sessions that include the inhalation of salvinorin A. The first session will be completed in a comfortable space furnished as a living room, and the second session will be conducted within a magnetic resonance imaging (MRI) scanner.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
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).
Primary Purpose: Other
Condition  ICMJE Drug Effect
Intervention  ICMJE Drug: Salvinorin A
Salvinorin A, blinded doses
Other Name: salvia, salvia divinorum
Study Arms  ICMJE Experimental: Salvinorin A administration
All volunteers will be assigned to the salvinorin A administration arm.
Intervention: Drug: Salvinorin A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2020)
13
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2018)
20
Actual Study Completion Date  ICMJE March 2, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03418714
Other Study ID Numbers  ICMJE IRB00131537
5R01DA003889-31 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Frederick S Barrett, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP