Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Phase 1

• Conditions: Amphetamine-Related Disorders

• Registration Number: NCT00265278
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 Timeline

• Study Start: 2005-03
• Status Verified: 2005-12
• Study First Submitted: 2005-12-13
• Study First Submitted QC: 2005-12-13
• Study First Posted: 2005-12-14
• Study Completion: 2006-03
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiovascular
Subjective symptoms/Mood Effects

Trial Locations

Locations (1)

U of CA, San Francisco; 🇺🇸 San Francisco, California, United States