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

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Langley Porter Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Tolerability

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic parameters
Safety
Cardiovascular responses
Psychological effects of lobeline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

August 21, 2007

First Posted (ESTIMATE)

August 22, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CPU-0009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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