To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1
Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00100074
Collaborator
(none)
8
1
7
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Study Details
Study Description
Brief Summary
To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.
Study Design
Study Type:
Interventional
Primary Purpose:
Diagnostic
Official Title:
Safety and Tolerability Study of Sublingual Lobeline
Study Start Date
:
Sep 1, 2004
Study Completion Date
:
Apr 1, 2005
Outcome Measures
Primary Outcome Measures
- Safety []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy individuals with a body mass index between 18 and 30.
-
Willing and able to give written consent.
-
Must have a negative drug test
-
Females must have a negative pregnancy test prior to study drug administration
-
Must have no medical contraindications as determined by routine testing
Exclusion Criteria:
- Please contact the site for more information
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U of CA, San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Reese Jones, M.D., Langley Porter Psychiatric Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00100074
Other Study ID Numbers:
- NIDA-CPU-0007-1
First Posted:
Dec 23, 2004
Last Update Posted:
Jan 11, 2017
Last Verified:
Dec 1, 2004