Ph1 Lobeline Interaction Study - 1

This study is currently recruiting participants.

Verified by National Institute on Drug Abuse (NIDA), February 2007

First Received: February 22, 2007 Last Updated: October 23, 2007 History of Changes

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00439504

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Lobeline Lobeline sulfate

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:

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

Study ID Numbers:	NIDA-CPU-0012-1
Study First Received:	February 22, 2007
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00439504 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Methamphetamine
Lobeline
Nicotinic Agonists

Amphetamine
Peripheral Nervous System Agents
Cholinergic Agents

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Lobeline
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009