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Clinical Trials/NCT00265278
NCT00265278
Unknown
Phase 1

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

National Institute on Drug Abuse (NIDA)1 site in 1 country16 target enrollmentMarch 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Amphetamine-Related Disorders
Sponsor
National Institute on Drug Abuse (NIDA)
Enrollment
16
Locations
1
Primary Endpoint
Cardiovascular
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
March 2006
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Cardiovascular

Subjective symptoms/Mood Effects

Study Sites (1)

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