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Placebo Controlled Study of Sublingual Salvinorin A (6A)

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ClinicalTrials.gov Identifier: NCT01149824
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Pharmaceutical Preparations Drug: Salvinorin A Drug: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Dose Escalating Drug: Salvinorin A
Drug: Placebo



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


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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

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

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 Posted: June 24, 2010    Key Record Dates
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