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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
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00439504
First received: February 22, 2007
Last updated: October 23, 2007
Last verified: February 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
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 May 21, 2013