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

Methamphetamine Dependence Clinical Trial

— 5I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01919437
• Other study ID #: 2011.118-2
• Status: Active, not recruiting
• Phase: N/A
• First received: May 29, 2013
• Last updated: August 7, 2013
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Device:
• Web-Enabled Cognitive Neuropsychological Evaluation System

Locations

Country	Name	City	State
United States	CPMC Addiction & Pharmacology Research Laboratory	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute	Creare, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No