Clinical TrialHealthy VolunteersPlaceboCompleted

Effects of Salvinorin A in Healthy Controls

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
105 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, crossover early-phase study in healthy volunteers testing inhaled Salvinorin A at multiple single-dose levels (250, 500, 750 µg) versus placebo for basic science outcomes.

Primary purpose listed as basic science; outcomes and measures focused on acute subjective and physiological responses. Actual enrolment reported as 105 participants.

Study Arms & Interventions

Salvinorin A

experimental

Active Salvinorin A (three dose levels) in crossover design.

Interventions

  • Compound250 - 750 µg
    via Inhalation• single dose

    Low 250 µg; Medium 500 µg; High 750 µg; inhaled.

Placebo

inactive

Placebo (30% ethanolic solution).

Interventions

  • Placebo
    via Inhalation• single dose

    30% ethanolic solution as placebo.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Previous exposure to inhaled Salvinorin A (SA).

Exclusion Criteria

No exclusion criteria listed.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment105 participants
  • Timeline
    Start: 2009-01-01
    End: 2021-01-12
  • Compound
    Placebo
  • Topic
    Healthy Volunteers

Locations

VA Connecticut Healthcare System — West Haven, Connecticut, United States

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