Mobile Medication Adherence Platform for Buprenorphine-Naloxone During Treatment of Opioid Use Disorder: Phase I Study
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      The investigators will conduct a phase I study involving 41 participants selected randomly
      among patients prescribed buprenorphine-naloxone for opioid misuse as a feasibility trial of
      the study of the Pillsy device. The study will track the effectiveness of the Pillsy
      technology and associated smartphone application by measuring adherence to
      buprenorphine-naloxone therapy and patient satisfaction with the application and the Pillsy
      device.
    

Detailed description: 
      The purpose of this randomized, controlled trial in Phase I is to determine whether the
      Pillsy intervention can improve adherence to buprenorphine-naloxone compared to Service As
      Usual.

      This will be a collaborative study between WSU, Pillsy, Inc, and the clinical site Ideal
      Options (opioid use and other substance use disorders treatment center). The overarching goal
      is to evaluate if the use of the Pillsy system will improve treatment adherence. The study
      coordinator will work closely with the clinical site, conducting a scripted screening, by
      phone or in person, documenting substance use, addiction treatment history, medical and
      psychiatric history, medication, addiction treatment goals, and availability of social
      support.

      The Pillsy device is a smart cap that tracks pill bottle openings and uses lighted reminders
      to prompt patients when to take their medication. The Pillsy Helper feature is a smartphone
      application that sends text and phone reminders as well as links to the participant named
      family and friend support networks. The Pillsy Helpers feature allows participants to name
      friends and family members who will also receive a text message notification 1 hour after a
      missed dose to reach out to offer support. In addition, the prescriber will be contacted when
      the patient has missed a dose, giving the prescriber the opportunity to intervene. Study
      participants will be randomized to one of two groups. The control group will receive the
      Pillsy cap alone. The active group will receive the Pillsy cap and smartphone application
      with associated benefits. To measure adherence, all participants will provide a urine sample
      at each study visit and complete a questionnaire (ex: AUDIT, Fagerstrom, Addiction Severity
      Index, Timeline Follow-Back) and survey that assesses their satisfaction with treatment.
    

Intervention name(s): Reminders messages to improve adherence.
Intervention type(s): Behavioral
Intervention description(s): If the participant does not take their medicine at the correct time, a light on the smart pill cap begins to flash. If the bottle is not opened within 20 minutes, the Pillsy application sends an SMS text reminder to the participant's phone. If the bottle is not opened within 60 minutes, the participant receives an automated phone call. The participant may also receive brief motivational phrases or craving surveys that can be tailored to participant needs and preferences. Also, based on pre-populated and adjustable craving and withdrawal levels, the participants' provider could be contacted automatically based on the thresholds being crossed. Pillsy also includes a "Pillsy Helpers" feature in which the patient can name friends and family members who will also receive a text message notification one hour after a missed dose.
Other intervention name(s): Flashing cap; Automated phone call.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care