Human Psychopharmacology of Salvinorin A

NCT ID: NCT00996411

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Salvinorin A

Group Type: EXPERIMENTAL

Salvinorin A

Intervention Type: DRUG

This is an initial dose ranging study

Interventions

Salvinorin A

This is an initial dose ranging study

Intervention Type: DRUG

Eligibility 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

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Roland Griffiths

Professor, Department of Psychiatry,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland Griffiths, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Matthew W Johnson, Ph.D.

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

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

Baltimore, Maryland, United States

Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00009081

Identifier Type: -

Identifier Source: org_study_id