Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Salvinorin A in Healthy Controls

This study is ongoing, but not recruiting participants.
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: January 6, 2015
Last verified: January 2015

June 13, 2008
January 6, 2015
January 2009
August 2015   (final data collection date for primary outcome measure)
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 ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00700596 on ClinicalTrials.gov Archive Site
Not Provided
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. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effects of Salvinorin A in Healthy Controls
Psychotomimetic Effects of Kappa Opioid Receptor Agonist Salvinorin A in Healthy Controls

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • 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)
  • Active Comparator: 1
    Salvinorin A (SA)
    Intervention: Drug: Salvinorin A
  • Placebo Comparator: 2
    Control or Placebo SA
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
41
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700596
0707002884
Not Provided
Mohini Ranganathan, Yale University
Yale University
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Mohini Ranganathan, M.D. Yale University School of Medicine, Dept of Psychiatry
Yale University
January 2015

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