NCT00265278UnknownPhase 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 enrollmentStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Cardiovascular
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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