Ph1 Lobeline Interaction Study - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Information provided by:
National Institute on Drug Abuse (NIDA) Identifier:
First received: February 22, 2007
Last updated: October 23, 2007
Last verified: February 2007
The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.

Condition Intervention Phase
Methamphetamine Dependence
Drug: Lobeline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Cardiovascular responses

Secondary Outcome Measures:
  • Subjective effects

Estimated Enrollment: 10

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

Inclusion Criteria:

  • Be between the ages of 18 and 45 years of age
  • Be in general good health with a history of methamphetamine (MA) abuse (but not dependence)
  • If female and of child bearing potential, agrees to use birth control
  • Be able to understand and provide written informed consent
  • Have a body mass index between 18 and 30
  • Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use
  • Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission

Exclusion Criteria:

  • Please contact site for details
  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 identifier: NCT00439504

United States, California
Langley Porter Psychiatric Institute Recruiting
San Francisco, California, United States, 94143
Contact: Reese Jones, M.D.    415-476-7452   
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: Reese Jones, M.D. Langley Porter Psychiatric Institute
  More Information

No publications provided Identifier: NCT00439504     History of Changes
Other Study ID Numbers: NIDA-CPU-0012-1
Study First Received: February 22, 2007
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
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 November 27, 2015