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

Phase 1UnknownNCT00519259

National Institute on Drug Abuse (NIDA)12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Methamphetamine Dependence

Interventions

LobelineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Langley Porter Psychiatric Institute

San Francisco, California, United States

Outcomes

Primary Outcomes

Tolerability

Secondary Outcomes

Safety

Pharmacokinetic parameters

Cardiovascular responses

Psychological effects of lobeline

Data from ClinicalTrials.gov

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