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To Assess the Safety and Tolerability of 7.5, 15 and 30 mg of Sublingual Lobeline. - 1

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2004 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00100074
First Posted: December 23, 2004
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
To assess the safety and tolerability of 7.5, 15 and 30 mg of sublingual lobeline.

Condition Intervention Phase
Amphetamine-Related Disorders Drug: Lobeline Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Safety and Tolerability Study of Sublingual Lobeline

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

Primary Outcome Measures:
  • Safety

Estimated Enrollment: 8
Study Start Date: September 2004
Estimated Study Completion Date: April 2005
Detailed Description:
The primary objective of this study is to characterize the pharmacokinetics of three ascending doses of lobeline in normal volunteers.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals with a body mass index between 18 and 30.
  • Willing and able to give written consent.
  • Must have a negative drug test
  • Females must have a negative pregnancy test prior to study drug administration
  • Must have no medical contraindications as determined by routine testing

Exclusion Criteria:

  • Please contact the site for more information
  Contacts and Locations
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): NCT00100074


Locations
United States, California
U of CA, San Francisco
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
  More Information

ClinicalTrials.gov Identifier: NCT00100074     History of Changes
Other Study ID Numbers: NIDA-CPU-0007-1
First Submitted: December 22, 2004
First Posted: December 23, 2004
Last Update Posted: January 11, 2017
Last Verified: December 2004

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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