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Placebo Controlled Study of Sublingual Salvinorin A (6A)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01149824
First Posted: June 24, 2010
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
  Purpose
In this study, our aim is to determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. This study is an ascending-dose, placebo-controlled, single-site design in 8 Salvia-experienced subjects. Subjects will receive SA doses from 0-4000 µg. Doses will be separated by at least one day. The first two doses (0 and 100µg) will be double-blinded while the last four (250, 500, 1000, 2000 and 4000µg) will be single-blind.

Condition Intervention
Pharmaceutical Preparations Drug: Salvinorin A Drug: Placebo

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: A Double Blind Placebo Controlled Ascending Dose Pharmacodynamic and Tolerability Study of 100 to 4000 µg of Sublingual Salvinorin A

Further study details as provided by John Mendelson, MD, California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. [ Time Frame: 2 hours ]

Enrollment: 8
Study Start Date: June 2009
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dose Escalating Drug: Salvinorin A Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, aged 21-45
  • Experienced with hallucinogenic amounts of SA
  • Good physical and mental health
  • Able to give adequate informed consent

Exclusion Criteria:

  • Any medical or psychiatric condition which, in the investigators' opinion, would preclude safe or consistent participation
  • Significant acute or chronic medical disease
  • Female who is pregnant, lactating, or plans to become pregnant during the study period and within one month after study drug administration
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149824


Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: John Mendelson, MD California Pacific Medical Center
  More Information

Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01149824     History of Changes
Other Study ID Numbers: CPMC-APRL-6A
First Submitted: June 22, 2010
First Posted: June 24, 2010
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by John Mendelson, MD, California Pacific Medical Center Research Institute:
Salvia divinorum
Salvinorin A

Additional relevant MeSH terms:
Salvinorin A
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs