Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1
Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00519259
Collaborator
(none)
12
1
Study Details
Study Description
Brief Summary
The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline
Study Start Date
:
Feb 1, 2006
Outcome Measures
Primary Outcome Measures
- Tolerability []
Secondary Outcome Measures
- Safety []
- Pharmacokinetic parameters []
- Cardiovascular responses []
- Psychological effects of lobeline []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Must be able to provide written informed consent
-
Must have a body mass index between 18 and 30
-
Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
-
Must have a negative drug test at screening and admission
-
If female of child bearing potential, must agree to use birth control
Exclusion Criteria:
- Please contact the site for more information
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Langley Porter Psychiatric Institute | 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:
NCT00519259
Other Study ID Numbers:
- NIDA-CPU-0009-1
First Posted:
Aug 22, 2007
Last Update Posted:
Jan 11, 2017
Last Verified:
Jun 1, 2006
Additional relevant MeSH terms: