Placebo Controlled Study of Sublingual Salvinorin A | NCT01149824

Studies
Placebo Controlled Study of Sublingual Salvinorin A

NCT01149824

Sponsor

California Pacific Medical Center Research Institute

Status

Completed

Last Update Posted

May 31, 2013Estimated

Enrollment

8Actual

Phase

Not Applicable

Conditions

Pharmaceutical Preparations

Interventions

Salvinorin A
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Oct 2010Actual

First Submitted Date

Jun 22, 2010

First Submission Date that Met QC Criteria

Jun 23, 2010

First Posted Date

Jun 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2013

Last Update Posted Date

May 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research InstitutePrincipal Investigator

Lead Sponsor

California Pacific Medical Center Research InstituteOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
Dose Escalating	Other		Drug: Salvinorin A Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Salvinorin A	Drug		Dose Escalating
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine an active but tolerable sublingual dose (range 100 to 4000 µg) of Salvinorin A (SA) in experienced subjects.		2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Mendelson, MD	California Pacific Medical Center	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C090499	salvinorin A

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided