Using mHealth to Aid Opioid Medication Adherence Pilot Study

The purpose of this study is to evaluate the usability of a medication management aid for
opioid dependence named SubAID. The SubAID system is a smartphone application and medication
monitor designed to optimize adherence behaviors of an OD patient responsible for
administering bup/nal maintenance therapy medication.

Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week
period among a cohort of subjects prescribed bup/nal and undergoing OST.

- Stage 1 - 1 week: Participants will use only an electronic medication monitor
(MedSignals) in control mode to passively record baseline adherence to medication.

- Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone
application.

- Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone
application.

After each stage usability assessments will be conducted to evaluate satisfaction with the
products from participants.

Inclusion Criteria:

- At least 21 years of age

- Physician diagnosis of opioid dependence (OD)

- Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.

- Able to speak and read English

- Willing to provide written informed consent prior to study entry

- Able to understand the study

- Ownership of an Android or iPhone smartphone

Exclusion Criteria:

- Having any concurrent medical or psychiatric condition that, in the investigator's
opinion, may preclude participation in this study; or

- Cognitive or other impairment that would interfere with completing a
self-administered questionnaire.