Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Completed · Not applicable

Conditions studied: Medication Adherence

In brief

In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010). However, methods commonly used to determine compliance may result in inaccurate measurement of adherence. In this study, we propose to assess the effectiveness and safety of the ID-Cap System, a novel compliance measurement device, in a healthy population.

Key facts

Study ID

NCT02344251

Run by

Medical University of South Carolina

People needed

40

Starts

2016-06-01

Expected to finish

2017-12-01

Last updated by the study team

2018-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must be between the ages of 18 and 65 years
• If female and of childbearing potential, must agree to use acceptable methods of birth control for the duration of the trial
• Must consent to random assignment, and be willing to commit to medication ingestion
• Must be able to read and provide informed consent
• Must function at an intellectual level sufficient to allow accurate completion of assessments
• Must have a Body Mass Index (BMI) below 35

You may not qualify if…

• Women who are pregnant, nursing, or plan to become pregnant during the course of the study
• Must not have evidence of a significant medical condition which may affect capsule passage through the gastrointestinal tract (including, but not limited to, Crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis)
• Must not have a current major psychiatric disorder as these may interfere with assessment measures
• Must not be currently dependent on other substances, with the exception of nicotine or caffeine, within the past 60 days
• Hypersensitivity to riboflavin or any capsule component;
• Individuals with embedded electronic devices
• Patients who, in the investigator's opinion, would be unable to comply with study procedures or assessments, or would be unacceptable study candidates (e.g., poses threat to staff)

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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