Effects of Salvinorin A in Healthy Controls
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ClinicalTrials.gov Identifier: NCT00700596 |
Recruitment Status :
Active, not recruiting
First Posted : June 18, 2008
Last Update Posted : January 11, 2021
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Sponsor:
Yale University
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
Tracking Information | ||||
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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 |
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 |
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 |
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 |
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Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Estimated Enrollment ICMJE |
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). |
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Sex/Gender ICMJE |
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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 |
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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 |