Effects of Salvinorin A in Healthy Controls

• ClinicalTrials.gov Identifier: NCT00700596
• Recruitment Status: Completed
• First Posted: June 18, 2008
• Last Update Posted: April 7, 2022
• Sponsor: Yale University
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Information provided by (Responsible Party): Mohini Ranganathan, Yale University

Tracking Information

• First Submitted Date: June 13, 2008
• First Posted Date: June 18, 2008
• Last Update Posted Date: April 7, 2022
• Actual Study Start Date: February 12, 2009
• Actual Primary Completion Date: August 22, 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Effects of Salvinorin A in Healthy Controls
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 6, 2022): 105
• Original Estimated Enrollment (submitted: June 17, 2008): 41
• Actual Study Completion Date: August 22, 2014
• Actual Primary Completion Date: August 22, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00700596
• Other Study ID Numbers: 0707002884
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mohini Ranganathan, Yale University
• Original Responsible Party: Yale University (Mohini Ranganathan, M.D.), Mohini Ranganathan, M.D., Yale University School of Medicine, Dept of Psychiatry
• Current Study Sponsor: Yale University
• Original Study Sponsor: Same as current
• Collaborators: National Alliance for Research on Schizophrenia and Depression

Investigators

• Principal Investigator: Mohini Ranganathan, M.D.; Yale University School of Medicine, Dept of Psychiatry

• PRS Account: Yale University
• Verification Date: April 2022