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Effects of Salvinorin A in Healthy Controls

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700596
First Posted: June 18, 2008
Last Update Posted: February 23, 2017
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.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
  Purpose
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 Intervention Phase
Healthy Drug: Salvinorin A Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Mohini Ranganathan, Yale University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 41
Study Start Date: January 2009
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
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
Principal Investigator: Mohini Ranganathan, M.D. Yale University School of Medicine, Dept of Psychiatry
  More Information

Responsible Party: Mohini Ranganathan, Associate Professor of Psychiarty, Yale University
ClinicalTrials.gov Identifier: NCT00700596     History of Changes
Other Study ID Numbers: 0707002884
First Submitted: June 13, 2008
First Posted: June 18, 2008
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Mohini Ranganathan, Yale University:
Salvia
SA
Salvinorin
Psychotomimetic Effects

Additional relevant MeSH terms:
Salvinorin A
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs