Overview

This trial is active, not recruiting.

Condition healthy
Treatments salvinorin a, placebo
Phase phase 1
Sponsor Yale University
Collaborator National Alliance for Research on Schizophrenia and Depression
Start date January 2009
End date August 2017
Trial size 41 participants
Trial identifier NCT00700596, 0707002884

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Active Comparator)
Salvinorin A (SA)
salvinorin a SA
Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg
(Placebo Comparator)
Control or Placebo SA
placebo
Control or Placebo SA (30 % ethanolic solution)

Primary Outcomes

Measure
Positive and Negative Syndrome Scale, Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale, Assessment of Opioid Effects, Cognitive Testing
time frame: Time Frame: -30, +10, +30, +90, +120. +200

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls
Principal investigator Mohini Ranganathan, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.