Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

December 13, 2005

Last Updated Date

October 25, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cardiovascular
Subjective symptoms/Mood Effects

Original Primary Outcome Measures ^ICMJE

Cardiovasular
Subjective symptoms/Mood Effects

Change History

Complete list of historical versions of study NCT00265278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Official Title ^ICMJE

Double-Blind, Placebo-Controlled Assessment of Interactions Between Intravenous Methamphetamine and Modafinil

Brief Summary

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

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).

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Condition ^ICMJE

Amphetamine-Related Disorders

Intervention ^ICMJE

Drug: Modafinil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00265278

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CPU-0008-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Reese Jones, M.D.

Langley Porter Psychiatric Institute

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP