NCT01149824

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

June 22, 2010

Last Update Submit

May 29, 2013

Conditions

Pharmaceutical Preparations

Keywords

Salvia divinorumSalvinorin A

Outcome Measures

Primary Outcomes (1)

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

    2 hours

Study Arms (1)

Dose Escalating

OTHER
Drug: Salvinorin ADrug: Placebo

Interventions

Salvinorin ADRUG
Dose Escalating
PlaceboDRUG
Dose Escalating

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, aged 21-45
  • Experienced with hallucinogenic amounts of SA
  • Good physical and mental health
  • Able to give adequate informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

salvinorin A

Study Officials

  • John Mendelson, MD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 24, 2010

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

May 31, 2013

Record last verified: 2013-05