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: August 17, 2016

Last verified: August 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 13, 2008

Last Updated Date

August 17, 2016

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

August 2017 (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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

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 ]

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: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Estimated Completion Date

August 2017

Estimated Primary Completion Date

August 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

-Previous exposure to inhaled Salvinorin A (SA).

Gender

Both

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

Yale University

Verification Date

August 2016

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

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