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Placebo Controlled Study of Sublingual Salvinorin A

NCT ID: NCT01149824

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Pharmaceutical Preparations

Keywords

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Salvia divinorum Salvinorin A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Dose Escalating

Group Type OTHER

Salvinorin A

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Salvinorin A

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Mendelson, MD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Other Identifiers

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CPMC-APRL-6A

Identifier Type: -

Identifier Source: org_study_id