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Charleston, South Carolina 29425


Purpose:

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-M, a novel compliance measurement device, in a healthy population.


Study summary:

The primary objective of this clinical trial is to evaluate the acceptability, tolerability, and efficacy of the ID-Cap-M in a healthy population. The ID-Cap is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract. Participation in the study takes 3 visits over a period of approximately six weeks. The first visit is a screening visit to determine if participants are eligible to participate. After the initial assessment visit, participants will be randomized to one of two groups. Group 1 will have compliance measured by self-report and urine riboflavin levels. This group will not receive computer-chipped capsules, but will receive their medication in a bottle capped with a MEMS Track Cap, which records when the medication bottle is opened and closed. Group 2 will receive computer-chipped capsules and will have compliance measured by self-report, urine riboflavin levels, and data collected by an e-Tect reader. Participants randomized to this group will also receive reminder calls and/or text messages to ingest the study medication if a signal is not sent from the e-Tect reader to the study team within one hour of the scheduled medication administration time. They will also be using biometric identification technology to ensure that they are taking the capsules as directed, specifically electrocardiogram (ECG). After the initial screening visit, participants will be required to attend two clinic visits during the six-week study, a randomization visit and a one-week follow-up visit approximately one week after last medication dose.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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 other 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)


NCT ID:

NCT02344251


Primary Contact:

Principal Investigator
Aimee McRae-Clark, PharmD, BCPP
Medical University of South Carolina


Backup Contact:

N/A


Location Contact:

Charleston, South Carolina 29425
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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