Effects of Salvinorin A in Healthy Controls

NCT ID: NCT00700596

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-12

Study Completion Date

2014-08-22

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Salvinorin A (SA)

Group Type ACTIVE_COMPARATOR

Salvinorin A

Intervention Type DRUG

Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg

2

Control or Placebo SA

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Control or Placebo SA (30 % ethanolic solution)

Interventions

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Salvinorin A

Low dose: Active SA 250μg Medium Dose: Active SA 500μg High Dose: Active SA 750μg

Intervention Type DRUG

Placebo

Control or Placebo SA (30 % ethanolic solution)

Intervention Type DRUG

Other Intervention Names

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SA Salvia Salvia Divinorim

Eligibility Criteria

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Inclusion Criteria

-Previous exposure to inhaled Salvinorin A (SA).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Alliance for Research on Schizophrenia and Depression

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mohini Ranganathan

Associate Professor of Psychiarty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohini Ranganathan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine, Dept of Psychiatry

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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0707002884

Identifier Type: -

Identifier Source: org_study_id

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