Placebo Controlled Study of Sublingual Salvinorin A (6A)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01149824
First received: June 22, 2010
Last updated: May 29, 2013
Last verified: May 2013
  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: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149824

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

No publications provided

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
Study First Received: June 22, 2010
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by California Pacific Medical Center Research Institute:
Salvia divinorum
Salvinorin A

ClinicalTrials.gov processed this record on July 24, 2014