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Ph1 Lobeline Interaction Study - 1

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ClinicalTrials.gov Identifier: NCT00439504
Recruitment Status : Unknown
Verified February 2007 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Recruiting
First Posted : February 23, 2007
Last Update Posted : January 11, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular responses

Secondary Outcome Measures :
  1. Subjective effects

Eligibility Criteria

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:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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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): NCT00439504


Locations
United States, California
Langley Porter Psychiatric Institute Recruiting
San Francisco, California, United States, 94143
Contact: Reese Jones, M.D.    415-476-7452    reese@itsa.ucsf.edu   
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: NCT00439504     History of Changes
Other Study ID Numbers: NIDA-CPU-0012-1
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: February 2007

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