Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
5I
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 9, 2013
August 1, 2013
6 months
May 29, 2013
August 7, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of neurocognitive task results
Results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions.
2 weeks
Study Arms (1)
Web-Enabled Cognitive Neuropsychological Evaluation System
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, aged 18 to 55.
- Ability to give informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- California Pacific Medical Center Research Institutelead
- Creare, Inc.collaborator
Study Sites (1)
CPMC Addiction & Pharmacology Research Laboratory
San Francisco, California, 94107, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
May 29, 2013
First Posted
August 9, 2013
Study Start
April 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2013
Last Updated
August 9, 2013
Record last verified: 2013-08