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Human Psychopharmacology of Salvinorin A

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00996411
First received: October 15, 2009
Last updated: March 21, 2014
Last verified: March 2014

October 15, 2009
March 21, 2014
November 2008
November 2013   (final data collection date for primary outcome measure)
Hallucinogen Rating Scale [ Time Frame: Approximately 1 hour after drug administration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00996411 on ClinicalTrials.gov Archive Site
Not Provided
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Human Psychopharmacology of Salvinorin A
Not Provided

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
Drug: Salvinorin A
This is an initial dose ranging study
Experimental: Salvinorin A
Intervention: Drug: Salvinorin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
Not Provided
November 2013   (final data collection date for primary outcome measure)

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:

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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00996411
NA_00009081
Not Provided
Roland Griffiths, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Roland Griffiths, Ph.D. Johns Hopkins University
Study Director: Matthew W Johnson, Ph.D. Johns Hopkins University
Johns Hopkins University
March 2014

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