Effects of Salvinorin A in Healthy Controls
This study is currently recruiting participants.
Verified December 2012 by Yale University
Sponsor:
Yale University
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00700596
First received: June 13, 2008
Last updated: December 3, 2012
Last verified: December 2012
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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 2014 |
| Estimated Primary Completion Date: | August 2014 (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:
|
|
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: Ashley M Schnakenberg, B.S. | 203-932-5711 ext 4485 | ashley.schnakenberg@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: | Yale University (Mohini Ranganathan, M.D.), Mohini Ranganathan, M.D., Yale University School of Medicine, Dept of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00700596 History of Changes |
| Other Study ID Numbers: | 0707002884 |
| Study First Received: | June 13, 2008 |
| Last Updated: | December 3, 2012 |
| 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 June 18, 2013