NCT00519259

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2006

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
Last Updated

January 11, 2017

Status Verified

June 1, 2006

First QC Date

June 29, 2006

Last Update Submit

January 10, 2017

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

  • Tolerability

Secondary Outcomes (4)

  • Safety

  • Pharmacokinetic parameters

  • Cardiovascular responses

  • Psychological effects of lobeline

Interventions

LobelineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Please contact the site for more information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Lobeline

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Reese Jones, M.D.

    Langley Porter Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 29, 2006

First Posted

August 22, 2007

Study Start

February 1, 2006

Last Updated

January 11, 2017

Record last verified: 2006-06

Locations

US(1)