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OpenTrials
Completed

NCT Number: NCT01149824

Placebo Controlled Study of Sublingual Salvinorin A

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.

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Key information

Conditions

Pharmaceutical Preparations

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salvinorin A

Drug

Placebo

Drug

Primary outcomes

  1. To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Official study title

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

Acronym: 6A

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 24, 2010
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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