Adherence Monitoring For Substance Abuse Clinical Trials

NCT ID: NCT01867476

Last Updated: 2013-06-04

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

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-02-28

Brief Summary

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The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.

Detailed Description

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Conditions

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Medication Adherence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Normals

Automated Adherence Monitoring System

Intervention Type OTHER

Interventions

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Automated Adherence Monitoring System

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18 to 60
* Ability to give informed consent.
* Be willing and able to use the study-provided phone for taking and transmitting capsule photos.

Exclusion Criteria

* Unwilling or unable to use a cell phone.
* 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

60 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

Principal Investigators

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John Mendelson, MD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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Addiction & Pharmacology Research Lab, St. Luke's Hospital

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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2012.075EXP

Identifier Type: -

Identifier Source: org_study_id

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