Ph1 Lobeline Interaction Study - 1 - Full Text View

Ph1 Lobeline Interaction Study - 1

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), February 2007

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

MedlinePlus related topics:

Methamphetamine

ChemIDplus related topics:

Lobeline Lobeline hydrochloride Lobeline sulfate Methamphetamine

U.S. FDA Resources

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

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

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