Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00265278

Purpose

The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral Modafinil.

Condition	Intervention	Phase
Amphetamine-Related Disorders	Drug: Modafinil	Phase I

MedlinePlus related topics: Methamphetamine

Drug Information available for: Modafinil Amphetamine 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 Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

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

Primary Outcome Measures:

Cardiovascular
Subjective symptoms/Mood Effects

Estimated Enrollment:	16
Study Start Date:	March 2005
Estimated Study Completion Date:	March 2006

Detailed Description:

The primary aims of this experiment are to determine if there are significant safety interactions between oral modafinil and intravenous methamphetamine. Safety will be assessed by measuring adverse events and cardiovascular responses of heart rate (HR), blood pressure (BP), and electrocardiogram (ECG) and stroke distance (ICG).

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

normotensive
good physical and mental health
body mass index between 18 and 30
if female, using an acceptable method of contraception and are not pregnant
able to give voluntary informed consent

Exclusion Criteria:

Please contact site for further details

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265278

Locations

United States, California
U of CA, San Francisco
San Francisco, California, United States, 94143

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-0008-1
Study First Received:	December 13, 2005
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00265278
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Methamphetamine
Dopamine
Mental Disorders
Amphetamine-Related Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Amphetamine
Modafinil

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants

Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009