ABSTRACT
Alcohol use disorders (AUDs) are a costly and burdensome health concern, affecting over 15 million adults
each year in the United States. Several FDA-approved medication-assisted therapies (MATs) are used for the
treatment of AUD, with disulfiram (Antabuse) the oldest and one of the most common. Disulfiram acts as a
“psychological deterrent” and causes physiological reactions when taken with alcohol. Despite demonstrated
efficacy for decreasing relapse, disulfiram is underutilized: efficacy is best demonstrated under monitoring or
supervision, creating a barrier for use. Additionally, disulfiram adherence rates are low. The most common
reason for non-adherence is that an individual is contemplating or planning a relapse, which typically occurs
within 50 hours. Thus, disulfiram non-adherence can be a marker for relapse, providing a very short window for
intervention. Technological advances now allow for electronic medication monitoring: devices are designed to
objectively track adherence. The Wisepill device is an electronic medication monitoring system that pairs real-
time monitoring with a triggered text message (SMS) when doses are late. The Wisepill device plus medication
reminder SMS messages are associated with increased adherence to antiretroviral or diabetic therapy. Though
the capability exists, potentially therapeutic SMS messages paired with Wisepill objective monitoring have yet
to tested in any population. Indeed, previous research suggests that supportive and relapse prevention/coping
skills SMS message interventions are effective in reducing alcohol use. Thus, given that disulfram non-
adherence can signify a critical clinical concern (i.e., impending relapse), the delivery of a tailored, relapse
prevention-focused, just-in-time SMS soon after disulfiram discontinuation could have a significant impact on
AUD treatment outcomes. We propose to develop an intervention capitalizing on the Wisepill technology to pair
real-time medication monitoring with tailored (a) real-time triggered reminders, (b) real-time abstinence
support, and (c) relapse prevention SMS texts for individuals with AUD being treated with disulfram.
We propose to develop a 12-week Wisepill+SMS intervention for individuals in alcohol treatment on
disulfiram. This will include: 1) an in-person Wisepill orientation session to introduce the device and generate
tailored relapse prevention messages; 2) use of the Wisepill device during the intensive treatment program and
after discharge; 3) tailored SMS messages paired with use of the Wisepill device: a) supportive messages with
medication compliance, b) reminder messages for early non-adherence (e.g., 1 hour late) and c) relapse-
prevention messages after longer periods of non-adherence (e.g., several hours). The goal of this application
is to develop the Wisepill+SMS intervention with the aid of focus groups (n=20), then test the Wisepill+SMS
intervention in a RCT (n=75) comparing Wisepill+SMS to Wisepill only (i.e., no SMS) and disulfiram only (i.e.,
no Wisepill, no SMS). The Wisepill device, and its associated real-time monitoring and messaging systems,
are relatively low-cost, easy to program, and can deliver an intervention that would reduce barriers to care.
