Back to resultsTo Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1
Primary Purpose
Amphetamine-Related Disorders
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lobeline
Sponsored by
About this trial
This is an interventional diagnostic trial for Amphetamine-Related Disorders
Eligibility Criteria
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
Sites / Locations
- U of CA, San Francisco
Outcomes
Primary Outcome Measures
Safety
Secondary Outcome Measures
Full Information
NCT ID
NCT00100074
First Posted
December 22, 2004
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00100074
Brief Title
To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1
Official Title
Safety and Tolerability Study of Sublingual Lobeline
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.
Detailed Description
The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Enrollment
8 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lobeline
Primary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reese Jones, M.D.
Organizational Affiliation
Langley Porter Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
U of CA, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1
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