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
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: December 22, 2004
Last updated: October 25, 2007
Last verified: December 2004
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.

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

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
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Please refer to this study by its identifier: NCT00100074

United States, California
U of CA, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute
  More Information 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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on May 05, 2016