Placebo Controlled Study of Sublingual Salvinorin A

Pharmaceutical Preparations Clinical Trial

— 6A  

Official title:

A Double Blind Placebo Controlled Ascending Dose Pharmacodynamic and Tolerability Study of 100 to 4000 µg of Sublingual Salvinorin A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149824
• Other study ID #: CPMC-APRL-6A
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: May 29, 2013
• Start date: June 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pharmaceutical Preparations

Intervention

Drug:
• Salvinorin A

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.		2 hours	No