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 because the information has not been verified recently.
Verified December 2004 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:
NCT00100074
First received: December 22, 2004
Last updated: October 25, 2007
Last verified: December 2004
  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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100074

Locations
United States, California
U of CA, San Francisco
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: NCT00100074     History of Changes
Other Study ID Numbers: NIDA-CPU-0007-1
Study First Received: December 22, 2004
Last Updated: October 25, 2007
Health Authority: United States: Food and Drug Administration

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
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 August 21, 2014