Human Psychopharmacology of Salvinorin A

NCT00996411 | Completed Phase 1

• 1 other identifier: NA_00009081
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hallucinogen Rating Scale

  Approximately 1 hour after drug administration

Study Arms (1)

Salvinorin A

EXPERIMENTAL

Drug: Salvinorin A

Interventions

Salvinorin A DRUG

This is an initial dose ranging study

Salvinorin A

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Behavioral Pharmacology Research Unit, Johnson Hopkins Univ. School of Med.

Baltimore, Maryland, 21224, United States

Location

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Behavior

Interventions

salvinorin A

Study Officials

• Roland Griffiths, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Matthew W Johnson, Ph.D.

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychiatry,

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: November 1, 2008
• Primary Completion: November 1, 2013
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

US (2)