Human Psychopharmacology of Salvinorin A
This study is currently recruiting participants.
Verified March 2013 by Johns Hopkins University
Sponsor:
Johns Hopkins University
Collaborator:
Information provided by (Responsible Party):
Roland Griffiths, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00996411
First received: October 15, 2009
Last updated: March 6, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996411
Contacts
| Contact: Mary Cosimano, MSW | 410-550-5990 | mcosima1@jhmi.edu |
Locations
| United States, Maryland | |
| Behavioral Pharmacology Research Unit | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Matthew W Johnson, Ph.D. 410-550-0056 mwj@jhu.edu | |
| Principal Investigator: Roland Griffiths, Ph.D. | |
| Sub-Investigator: Matthew W Johnson, Ph.D. | |
| Sub-Investigator: Annie Umbricht, M.D. | |
| Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med. | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Matthew W Johnson, Ph.D. 410-550-0056 mwj@jhu.edu | |
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 6, 2013 |
| 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 June 17, 2013