Placebo Controlled Study of Sublingual Salvinorin A (6A)

California Pacific Medical Center Research Institute

Status: Completed

Conditions: Pharmaceutical Preparations

Treatments: Drug: Salvinorin A; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01149824

CPMC-APRL-6A

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

Dose Escalating

Other group

Treatment:

Drug: Placebo

Drug: Salvinorin A