Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

NCT ID: NCT00265278

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Amphetamine-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Modafinil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Reese Jones, M.D.

Role: PRINCIPAL_INVESTIGATOR

Langley Porter Psychiatric Institute

Locations

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U of CA, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CPU-0008-1

Identifier Type: -

Identifier Source: org_study_id

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