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NCT00519259 Clinical Trial

Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1

Methamphetamine Dependence Clinical Trial

Official title:
Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00519259
Other study ID # NIDA-CPU-0009-1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received June 29, 2006
Last updated January 10, 2017
Start date February 2006

Study information
Verified date June 2006
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

The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 12
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lobeline

Locations
Country Name City State
United States Langley Porter Psychiatric Institute 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 Tolerability
Secondary Safety
Secondary Pharmacokinetic parameters
Secondary Cardiovascular responses
Secondary Psychological effects of lobeline
See also
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