Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology

Abstract
Methadone is a highly effective treatment for opioid use disorder (OUD), but many patients
leave treatment prematurely, placing them at high risk of relapse and overdose. Extensive
research shows that comorbid cocaine use is associated with poor retention in methadone
treatment. The proposed study will examine a novel intervention designed to improve
methadone treatment retention and other outcomes among people with opioid and cocaine
polysubstance use. The design is a 2-arm randomized controlled trial conducted over a one-
year period following methadone treatment entry. Retention (primary) and drug use (secondary)
outcomes for methadone treatment as usual (TAU, n=120) will be compared with the addition of
the DynamiCare Health Contingency Management app (TAU+DCM, n=120). DCM is a personal
digital therapy tool provided as an app on the patient’s smart phone. Its central feature is the
delivery of evidence-based contingency management therapy in a convenient, remote, and fully
automated fashion that ensures validity of target behaviors and immediacy of reward delivery.
Two target behaviors relevant to retention will be the primary focus of the DCM program: 1)
abstinence from opiates and cocaine as verified via remote oral fluid testing, and 2) medication
pickup from the methadone program as verified by clinic records. Participants in the TAU+DCM
arm will receive financial rewards for achieving these pre-determined behavioral targets over a
48-week intervention period. Comprehensive assessment of all participants will be conducted at
baseline, 3-, 6- and 12-months. Aim 1: To determine the relative effectiveness of TAU+DCM
compared to TAU alone in improving methadone treatment retention through 12-months post
treatment entry. Aim 2: To determine the relative effectiveness of TAU+DCM compared to TAU
alone in terms of [AIM 2a] reducing opioid use and cocaine use; and [Aim 2b] improving other
secondary outcomes including non-targeted substance use and quality of life through 12-
months post treatment entry. Aim 3: To explore app use patterns, acceptability, and perceived
value of the personalized treatment intervention through 12-months post treatment entry.
Innovation lies in the platform and structure of CM delivery that ensures treatment fidelity with
automation of remote behavioral monitoring and reward delivery without involvement of clinical
staff. This project represents a novel application of digital therapeutics to enhance the
effectiveness of OUD treatment with polysubstance use. Findings from this project can improve
the public health impact of methadone treatment by identifying an effective and scalable
approach to address polysubstance use among patients at heightened risk of treatment dropout.

Grant Number: 4R01DA057608-02
NIH Institute/Center: NIH
Principal Investigator: Karen Alexander