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

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ClinicalTrials.gov Identifier: NCT00519259
Recruitment Status : Unknown
Verified June 2006 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : August 22, 2007
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

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

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Drug: Lobeline Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline
Study Start Date : February 2006



Primary Outcome Measures :
  1. Tolerability

Secondary Outcome Measures :
  1. Safety
  2. Pharmacokinetic parameters
  3. Cardiovascular responses
  4. Psychological effects of lobeline


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519259


Locations
United States, California
Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute

ClinicalTrials.gov Identifier: NCT00519259     History of Changes
Other Study ID Numbers: NIDA-CPU-0009-1
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: June 2006

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