5I: Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System

• Sponsor: California Pacific Medical Center Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01919437
• Collaborator: Creare, Inc. (Industry)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 18
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine Dependence	Device: Web-Enabled Cognitive Neuropsychological Evaluation System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Anticipated Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Web-Enabled Cognitive Neuropsychological Evaluation System	Device: Web-Enabled Cognitive Neuropsychological Evaluation System

Outcome Measures

Primary Outcome Measures

1. Comparison of neurocognitive task results [2 weeks]

   Results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CPMC Addiction & Pharmacology Research Laboratory	San Francisco	California	United States	94107

Sponsors and Collaborators

• California Pacific Medical Center Research Institute
• Creare, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Mendelson, MD, Senior Scientist, California Pacific Medical Center Research Institute
• ClinicalTrials.gov Identifier: NCT01919437
• Other Study ID Numbers: 2011.118-2
• First Posted: Aug 9, 2013
• Last Update Posted: Aug 9, 2013
• Last Verified: Aug 1, 2013

Study Results

No Results Posted as of Aug 9, 2013