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Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System

NCT ID: NCT01919437

Last Updated: 2013-08-09

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

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice.

The primary hypotheses are that results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions, that methamphetamine (MA) dependent participants will have worsened neurocognitive performance compared to healthy volunteers, and the platform will be acceptable to participants.

Detailed Description

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Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Web-Enabled Cognitive Neuropsychological Evaluation System

Group Type EXPERIMENTAL

Web-Enabled Cognitive Neuropsychological Evaluation System

Intervention Type DEVICE

Interventions

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Web-Enabled Cognitive Neuropsychological Evaluation System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18 to 55.
* Ability to give informed consent.

Exclusion Criteria

* Unwilling or unable to access the web over a cell phone or living in an area with no cell phone service.
* Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Creare, Inc.

INDUSTRY

Sponsor Role collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CPMC Addiction & Pharmacology Research Laboratory

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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2011.118-2

Identifier Type: -

Identifier Source: org_study_id