Human Psychopharmacology of Salvinorin A



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:21 - 65
Updated:5/3/2014
Start Date:November 2008
Contact:Mary Cosimano, MSW
Email:mcosima1@jhmi.edu
Phone:410-550-5990

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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.


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.
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