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Effects of Salvinorin A on Brain Function

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ClinicalTrials.gov Identifier: NCT03418714
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Drug Effect Drug: Salvinorin A Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Effects of Salvinorin A on Brain Function
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Salvinorin A administration
All volunteers will be assigned to the salvinorin A administration arm.
Drug: Salvinorin A
Salvinorin A, blinded doses
Other Name: salvia, salvia divinorum




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 (see eIRB Study Documents) and be approved by MRI technologist before each scan
  • Left-handedness (assessed by the Edinburgh Handedness Inventory)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418714


Contacts
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Contact: John Clifton, B.A. 410-550-3074 jclifto6@jhmi.edu

Locations
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United States, Maryland
Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: John Clifton, B.A.    410-550-3074    jclifto6@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Frederick S Barrett, Ph.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03418714     History of Changes
Other Study ID Numbers: IRB00131537
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Salvinorin A
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs