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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

Tracking Information
First Submitted Date  ICMJE June 22, 2010
First Posted Date  ICMJE June 24, 2010
Last Update Posted Date May 31, 2013
Study Start Date  ICMJE June 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo Controlled Study of Sublingual Salvinorin A
Official Title  ICMJE A Double Blind Placebo Controlled Ascending Dose Pharmacodynamic and Tolerability Study of 100 to 4000 µg of Sublingual Salvinorin A
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Condition  ICMJE Pharmaceutical Preparations
Intervention  ICMJE
  • Drug: Salvinorin A
  • Drug: Placebo
Study Arms  ICMJE Dose Escalating
Interventions:
  • Drug: Salvinorin A
  • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
8
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01149824
Other Study ID Numbers  ICMJE CPMC-APRL-6A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John Mendelson, MD, California Pacific Medical Center Research Institute
Study Sponsor  ICMJE California Pacific Medical Center Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Mendelson, MD California Pacific Medical Center
PRS Account California Pacific Medical Center Research Institute
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP