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Human Psychopharmacology of Salvinorin A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00996411
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : March 24, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date March 24, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Hallucinogen Rating Scale [ Time Frame: Approximately 1 hour after drug administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Psychopharmacology of Salvinorin A
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Salvinorin A
This is an initial dose ranging study
Study Arms  ICMJE Experimental: Salvinorin A
Intervention: Drug: Salvinorin A
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 Completed
Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
14
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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 NCT00996411
Other Study ID Numbers  ICMJE NA_00009081
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roland Griffiths, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Roland Griffiths, Ph.D. Johns Hopkins University
Study Director: Matthew W Johnson, Ph.D. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2014

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