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NCT00265278 Clinical Trial

Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Amphetamine-Related Disorders Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00265278
Other study ID # NIDA-CPU-0008-1
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received December 13, 2005
Last updated January 10, 2017
Start date March 2005
Est. completion date March 2006

Study information
Verified date December 2005
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 16
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Modafinil

Locations
Country Name City State
United States U of CA, San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular
Primary Subjective symptoms/Mood Effects
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