Effects of Salvinorin A in Healthy Controls

Tracking Information
First Submitted Date ICMJE	June 13, 2008
First Posted Date ICMJE	June 18, 2008
Last Update Posted Date	June 6, 2018
Study Start Date ICMJE	January 2009
Estimated Primary Completion Date	August 2019 (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	Complete list of historical versions of study NCT00700596 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	August 2019
Estimated Primary Completion Date	August 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: -Previous exposure to inhaled Salvinorin A (SA).
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	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	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	June 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP