Clinical TrialSafety & Risk ManagementPlaceboCompleted

Placebo Controlled Study of Sublingual Salvinorin A

In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.

Target Enrollment
8 participants
Study Type
Phase NA interventional
Design
Non-randomized, single Blind

Detailed Description

Ascending-dose, placebo-controlled, single-site study in 8 Salvia-experienced participants to determine tolerable sublingual doses of Salvinorin A.

Participants receive single-dose sublingual administrations separated by at least one day; doses include 0, 100, 250, 500, 1000, 2000 and 4000 µg; first two doses reportedly double-blinded with later doses single-blind per protocol text.

Study Protocol

Preparation

sessions

Dosing

7 sessions

Integration

sessions

Study Arms & Interventions

Salvinorin A

experimental

Ascending-dose sublingual Salvinorin A (0–4000 µg) in experienced subjects.

Interventions

  • Compound
    via Sublingual• single dose• 7 doses total

    Salvinorin A sublingual ascending doses: 0, 100, 250, 500, 1000, 2000, 4000 µg; doses separated by ≥1 day.

Placebo

inactive

Matched sublingual placebo.

Interventions

  • Placebo0 µg
    via Sublingual• single dose• 7 doses total

    Matching placebo administered in dose-escalation schedule.

Participants

Ages
21 – 45
Sexes
Male & Female

Inclusion Criteria

  • Male or female, aged 21-45
  • Experienced with hallucinogenic amounts of SA
  • Good physical and mental health
  • Able to give adequate informed consent

Exclusion Criteria

  • Any medical or psychiatric condition which, in the investigators' opinion, would preclude safe or consistent participation
  • Significant acute or chronic medical disease
  • Female who is pregnant, lactating, or plans to become pregnant during the study period and within one month after study drug administration

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomizedsingle Blind
  • Target Enrollment8 participants
  • Timeline
    Start: 2009-01-06
    End: 2010-01-10
  • Compound
    Placebo
  • Topic
    Safety & Risk Management

Locations

United States

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