Pharmaceutical Preparations
Conditions
Keywords
Salvia divinorum, 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.
Interventions
DRUGSalvinorin A
DRUGPlacebo
Sponsors
California Pacific Medical Center Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects. | 2 hours |
Outcome results
None listed