Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2005 by National Institute on Drug Abuse (NIDA). Recruitment status was Active, not recruiting

First Received on December 13, 2005. Last Updated on October 25, 2007 History of Changes

Sponsor:	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

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 Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00265278 History of Changes
Other Study ID Numbers:	NIDA-CPU-0008-1
Study First Received:	December 13, 2005
Last Updated:	October 25, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Amphetamine-Related Disorders
Substance-Related Disorders
Mental Disorders
Methamphetamine
Amphetamine
Modafinil
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012