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Effects of Salvinorin A in Healthy Controls

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00700596
Recruitment Status : Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : January 11, 2021
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Salvinorin A Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls
Study Start Date : January 2009
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: 1
Salvinorin A (SA)
Drug: Salvinorin A
Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg
Other Names:
  • SA
  • Salvia
  • Salvia Divinorim

Placebo Comparator: 2
Control or Placebo SA
Drug: Placebo
Control or Placebo SA (30 % ethanolic solution)

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00700596

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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
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Principal Investigator: Mohini Ranganathan, M.D. Yale University School of Medicine, Dept of Psychiatry
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Responsible Party: Mohini Ranganathan, Associate Professor of Psychiarty, Yale University Identifier: NCT00700596    
Other Study ID Numbers: 0707002884
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Keywords provided by Mohini Ranganathan, Yale University:
Psychotomimetic Effects
Additional relevant MeSH terms:
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Salvinorin A
Physiological Effects of Drugs
Psychotropic Drugs