ClinicalTrials.gg
CompletedNCT00996411Updated Mar 24, 2014

Human Psychopharmacology of Salvinorin A

A Phase 1 interventional study of Salvinorin A in Healthy, sponsored by Johns Hopkins University. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-24.

Sponsored by Johns Hopkins University · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
21 Years to 65 Years
Sex
All
01

Study summary

This study is characterizing the subject-rated and behavioral effects of salvinorin A in healthy volunteers. The investigators hypothesize the salvinorin A will have hallucinogen-like effects.

02

Conditions studied

  • Healthy

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Keywords

  • Healthy volunteers are being studied to evaluate the subject-rated, behavioral, and abuse liability effects of salvinorin A
03

In context

Behavior

404 studies on the registry are indexed under Behavior; 167 are open to participants now.

This study's planned enrollment of 14 is below the median of 120 across 316 interventional studies indexed under Behavior.

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Lead sponsor

Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have given written informed consent
  • Have a high school level of education
  • Have a self-reported interest in spirituality and altered states of consciousness
  • Have used hallucinogens (e.g., LSD, psilocybin mushrooms, Salvia divinorum) including having used Salvia divinorum or salvinorin A by the inhalation route (i.e., volunteers without histories of Salvia divinorum or salvinorin A use by the inhalation route will be excluded)
  • Be 21 to 65 years old
  • Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the volunteer does not routinely consume caffeinated beverages, he or she must agree not to do so on session days.
  • Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. As described elsewhere, exceptions include daily use of caffeine.
  • Be healthy as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocarroutine medical blood and urinalysis laboratory tests.

Exclusion criteria

Exclusion Criteria:

General Medical Exclusion Criteria

  • Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months stroke, peripheral or pulmonary vascular disease
  • Epilepsy with history of seizures
  • Diabetes mellitus
  • Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
  • Currently taking psychoactive prescription medication on a regular basis
  • More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table

Psychiatric Exclusion Criteria

  • Current or past history of meeting DSM-IV criteria for Schizophrenia, Psychotic Disorder (unless substance-induced or due to a medical condition), or Bipolar I or II Disorder.
  • Current severe Obsessive-Compulsive Disorder, Dysthymic Disorder, or Panic Disorder.
  • Current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine) or severe major depression.
  • Have a first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
  • Currently meets DSM-IV criteria for Dissociative Disorder, Anorexia Nervosa, Bulimia Nervosa, or other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to salvinorin A.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Salvinorin A

    Drug: Salvinorin A

Interventions

06

What researchers measure

Primary outcomes

  1. Hallucinogen Rating Scale

    Time frame: Approximately 1 hour after drug administration

07

Study locations

2 sites
  • Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med.
    Baltimore, Maryland 21224, United States
  • Behavioral Pharmacology Research Unit
    Baltimore, Maryland 21224, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008 and a primary completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2009
First posted
Oct 16, 2009
Start
Nov 2008
Primary completionActual
Nov 2013
Last update
Mar 24, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00996411
Responsible party
Roland Griffiths (Professor, Department of Psychiatry,, Johns Hopkins University) — Principal investigator
First posted
Oct 16, 2009
Start date
Nov 2008
Primary completion
Nov 2013
Last update
Mar 24, 2014

Study contacts

Roland Griffiths, Ph.D.
principal investigator · Johns Hopkins University
Matthew W Johnson, Ph.D.
study director · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Salvinorin A

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