Effects of Salvinorin A in Healthy Controls

This study is currently recruiting participants.
Verified April 2014 by Yale University
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT00700596
First received: June 13, 2008
Last updated: April 1, 2014
Last verified: April 2014
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: January 2009
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700596

Contacts
Contact: Brynn Huguenel, B.A. 203-932-5711 ext 4650 brynn.huguenel@yale.edu

Locations
United States, Connecticut
Clinical Neuroscience Research Unit Recruiting
New Haven, Connecticut, United States, 06519
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

No publications provided

Responsible Party: Mohini Ranganathan, Associate Professor of Psychiarty, Yale University
ClinicalTrials.gov Identifier: NCT00700596     History of Changes
Other Study ID Numbers: 0707002884
Study First Received: June 13, 2008
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Yale University:
Salvia
SA
Salvinorin
Psychotomimetic Effects

ClinicalTrials.gov processed this record on April 14, 2014