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Effects of Salvinorin A in Healthy Controls

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ClinicalTrials.gov Identifier: NCT00700596
Recruitment Status : Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University

Study Description
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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

Study Design
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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
Arms and Interventions
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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)


Outcome Measures
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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 ]

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

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00700596


Locations
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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
Investigators
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Principal Investigator: Mohini Ranganathan, M.D. Yale University School of Medicine, Dept of Psychiatry
More Information
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Responsible Party: Mohini Ranganathan, Associate Professor of Psychiarty, Yale University
ClinicalTrials.gov 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:
Salvia
SA
Salvinorin
Psychotomimetic Effects
Additional relevant MeSH terms:
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Salvinorin A
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs