Clinical TrialHealthy VolunteersCompleted

Effects of Salvinorin A on Brain Function

This study evaluates the effects of Salvinorin A (SA). SA is the active ingredient of the plant Salvia divinorum that is known to have been used by Mexican Indians as part of religious rituals. The purpose of this project is to understand what people experience when they consume Salvinorin A.

Target Enrollment
13 participants
Study Type
Phase I/II interventional
Design
Non-randomized

Detailed Description

This fMRI study examines the effects of inhaled salvinorin A on brain activity and connectivity in healthy volunteers (n=13). Participants complete two experimental inhalation sessions: one in a living-room-like setting and one during MRI.

Blinded doses of salvinorin A are administered via inhalation; primary measures include fMRI-derived activity and connectivity, with safety screening, laboratory tests, and monitoring of adverse events.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Salvinorin A

experimental

All volunteers assigned to salvinorin A administration (blinded doses). Two inhalation sessions: one in a living-room-like setting and one in the MRI scanner.

Interventions

  • Compound
    via Inhalation• single dose• 2 doses total

    Salvinorin A (blinded doses); two inhalation sessions (1 comfortable room, 1 MRI session).

Participants

Ages
21 – 50
Sexes
Male & Female

Inclusion 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

  • 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 Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment13 participants
  • Timeline
    Start: 2009-02-12
    End: 2024-08-22
  • Topic
    Healthy Volunteers

Locations

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States

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