Clinical TrialHealthy VolunteersCompleted

Human Psychopharmacology of Salvinorin A

Single-group Phase I dose-ranging study (n=14) characterising subjective and behavioural effects of salvinorin A in healthy volunteers, administered via inhalation.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Non-randomized, triple Blind

Detailed Description

Single‑group, triple‑masked, Phase I study in healthy volunteers assessing the subjective and behavioural effects of salvinorin A in an initial dose‑ranging protocol.

Participants must have prior inhalation use of Salvia/salvinorin A; sessions involve single inhaled administrations with dose escalation guided by safety assessments.

Outcomes focus on acute subjective effects, behavioural measures, and safety/tolerability through physiological monitoring and laboratory tests.

Study Arms & Interventions

Salvinorin A

experimental

Initial dose‑ranging, single‑group study of salvinorin A in healthy volunteers.

Interventions

  • Compound
    via Inhalation• single dose

    Salvinorin A — initial dose‑ranging; drug administered via inhalation (dose escalation per protocol).

Participants

Ages
21 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Have given written informed consent
  • Have a high school level of education
  • Have a self-reported interest in spirituality and altered states of consciousness
  • Have used hallucinogens (e.g., LSD, psilocybin mushrooms, Salvia divinorum) including having used Salvia divinorum or salvinorin A by the inhalation route (i.e., volunteers without histories of Salvia divinorum or salvinorin A use by the inhalation route will be excluded)
  • Be 21 to 65 years old
  • 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 routinely 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, within 24 hours of each drug administration. As described elsewhere, exceptions include daily use of caffeine.
  • Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram, routine medical blood and urinalysis laboratory tests.

Exclusion Criteria

  • Exclusion Criteria:
  • General Medical Exclusion Criteria
  • Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
  • Epilepsy with history of seizures
  • Diabetes mellitus
  • Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
  • Currently taking psychoactive prescription medication on a regular basis
  • More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
  • Psychiatric Exclusion Criteria
  • Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
  • Current severe Obsessive-Compulsive Disorder, Dysthymic Disorder, or Panic Disorder.
  • Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or 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.
  • Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to salvinorin A.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomizedtriple Blind
  • Target Enrollment14 participants
  • Timeline
    Start: 2008-01-11
    End: 2013-11-10
  • Topic
    Healthy Volunteers

Locations

Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med. — Baltimore, Maryland, United States
Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States

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