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NCT00100074 Clinical Trial

To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1

Amphetamine-Related Disorders Clinical Trial

Official title:
Safety and Tolerability Study of Sublingual Lobeline

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00100074
Other study ID # NIDA-CPU-0007-1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received December 22, 2004
Last updated January 10, 2017
Start date September 2004
Est. completion date April 2005

Study information
Verified date December 2004
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

Description:

The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 8
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Lobeline

Locations
Country Name City State
United States U of CA, San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
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