NCT00700596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for early_phase_1 healthy

Timeline
Completed

Started Feb 2009

Longer than P75 for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

February 12, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2014

Completed
Last Updated

April 7, 2022

Status Verified

April 1, 2022

Enrollment Period

5.5 years

First QC Date

June 13, 2008

Last Update Submit

April 6, 2022

Conditions

Healthy

Keywords

SalviaSASalvinorinPsychotomimetic Effects

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale, Clinician Administered Dissociative Symptoms Scale, Visual Analog Scale, Assessment of Opioid Effects, Cognitive Testing

    Time Frame: -30, +10, +30, +90, +120. +200

Study Arms (2)

1

ACTIVE COMPARATOR

Salvinorin A (SA)

Drug: Salvinorin A

2

PLACEBO COMPARATOR

Control or Placebo SA

Drug: Placebo

Interventions

Salvinorin ADRUG

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

Also known as: SA, Salvia, Salvia Divinorim
1
PlaceboDRUG

Control or Placebo SA (30 % ethanolic solution)

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Previous exposure to inhaled Salvinorin A (SA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Interventions

salvinorin A

Study Officials

  • Mohini Ranganathan, M.D.

    Yale University School of Medicine, Dept of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiarty

Study Record Dates

First Submitted

June 13, 2008

First Posted

June 18, 2008

Study Start

February 12, 2009

Primary Completion

August 22, 2014

Study Completion

August 22, 2014

Last Updated

April 7, 2022

Record last verified: 2022-04

Locations

US(1)