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

Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519259
Enrollment
12
Registered
2007-08-22
Start date
2006-02-28
Completion date
Unknown
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Dependence

Brief summary

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

Interventions

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Tolerability

Secondary

MeasureTime frame
Safety
Pharmacokinetic parameters
Cardiovascular responses
Psychological effects of lobeline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026