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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.
 
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

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 18, 2008
Last Update Posted Date January 11, 2021
Study Start Date  ICMJE January 2009
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
Positive and Negative Syndrome Scale, Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale, Assessment of Opioid Effects, Rey Auditory Verbal Learning Test (RAVLT), Cambridge Neuroscience Test Battery (CANTAB) [ Time Frame: Time Frame: -30, +10, +30 (RAVLT and CANTAB only), +90, +120, +200 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
Neurochemical and Pharmacokinetic Measures, Genetic Analysis, Long-term follow-up [ Time Frame: Time Frame: -30 (Day 1 - genetic sample collected), +15, +30, +60, +90. Long term follow-up 1 day, 1 month, 3 months post study completion. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Salvinorin A in Healthy Controls
Official Title  ICMJE Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Salvinorin A
    Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg
    Other Names:
    • SA
    • Salvia
    • Salvia Divinorim
  • Drug: Placebo
    Control or Placebo SA (30 % ethanolic solution)
Study Arms  ICMJE
  • Active Comparator: 1
    Salvinorin A (SA)
    Intervention: Drug: Salvinorin A
  • Placebo Comparator: 2
    Control or Placebo SA
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2008)
41
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00700596
Other Study ID Numbers  ICMJE 0707002884
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohini Ranganathan, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Alliance for Research on Schizophrenia and Depression
Investigators  ICMJE
Principal Investigator: Mohini Ranganathan, M.D. Yale University School of Medicine, Dept of Psychiatry
PRS Account Yale University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP