Adherence Monitoring For Substance Abuse Clinical Trials

Medication Adherence Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01867476
• Other study ID #: 2012.075EXP
• Status: Completed
• Phase: N/A
• First received: January 29, 2013
• Last updated: May 29, 2013
• Start date: January 2013
• Est. completion date: February 2013

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Automated Adherence Monitoring System

Locations

Country	Name	City	State
United States	Addiction & Pharmacology Research Lab, St. Luke's Hospital	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	Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval		+ 1, 2, 3, 4, 6 hours post dose	No