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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Salvinorin A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Hallucinogen Rating Scale [ Time Frame: Approximately 1 hour after drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: November 2008
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Salvinorin A Drug: Salvinorin A
This is an initial dose ranging study

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996411

Locations
United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med.
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Roland Griffiths, Ph.D. Johns Hopkins University
Study Director: Matthew W Johnson, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Roland Griffiths, Professor, Department of Psychiatry,, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00996411     History of Changes
Other Study ID Numbers: NA_00009081
Study First Received: October 15, 2009
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Healthy volunteers are being studied to evaluate the subject-rated, behavioral, and abuse liability effects of salvinorin A

ClinicalTrials.gov processed this record on August 21, 2014