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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00519259
First received: June 29, 2006
Last updated: October 25, 2007
Last verified: June 2006
  Purpose

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


Condition Intervention Phase
Methamphetamine Dependence
Drug: Lobeline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Tolerability

Secondary Outcome Measures:
  • Safety
  • Pharmacokinetic parameters
  • Cardiovascular responses
  • Psychological effects of lobeline

Estimated Enrollment: 12
Study Start Date: February 2006
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519259

Locations
United States, California
Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Sponsors and Collaborators
Investigators
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00519259     History of Changes
Other Study ID Numbers: NIDA-CPU-0009-1
Study First Received: June 29, 2006
Last Updated: October 25, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014