Remote Observed Dosing of Suboxone to Improve Clinical Practice

Opioid use disorder (OUD) is a significant public health problem. About 2 million Americans meet criteria for opioid use disorder involving prescription pain relievers and an additional 591,000 Americans meet criteria for a heroin use disorder. The rise in prescription opioid use in the US has resulted in a dramatic increase in heroin use, as prescription opioid users switch to heroin when their access to prescription opioids become less available. Opioids (including prescription opioids and heroin) killed more than 33,000 people in 2015, more than any year on record. Nearly half of all opioid overdose deaths involve a prescription opioid.

Buprenorphine, a partial agonist that exerts significant actions at the mu opioid receptor, has been shown to be effective for the treatment of OUD. Because it is a partial agonist and not prone to overdose, it is considered to be safe enough to dispense out of a clinician's office as opposed to an opiate treatment program (OTP). The availability of buprenorphine treatment outside of an OTP has significantly expanded the availability of effective treatment for OUD and is associated with reducing disparities related to treatment access.

While initial studies reported little evidence of buprenorphine diversion, more recent studies have indicated buprenorphine is prone to diversion and poor adherence that can significantly diminish its safety and efficacy. In these US clinical trials, adequate adherence to buprenorphine has been shown to occur in fewer than 50% of subjects who are prescribed the medication. In a trial involving 50 African American subjects with opioid use disorder participating in office based buprenorphine treatment, it was found that only 48% of the subjects were adherent to the medication as defined as having 80% or more of their visits associated with a positive UDS for buprenorphine. In another trial involving 703 subjects with opioid use disorder only 41% of the subjects took buprenorphine 80% of the days it was prescribed. Finally in an examination of medical and pharmacy claims data over a year, only 32% of patients participating in office based buprenorphine treatment took buprenorphine on 80% or more days.

Efforts to reduce poor adherence and diversion in buprenorphine maintenance generally include smaller prescriptions and more frequent office visits. An alternative to frequent face to face meetings is using smartphone technology to conduct remote observation of dosing (ROD). In addition, OUD patients have expressed that observed dosing of MMT and flexible dose prescription regimes play an important role in their treatment. However, there have been no published studies using ROD to monitor compliance of Suboxone.

Remote Observed Dosing Intervention We conducted a Stage 1B integrated cellphone based behavioral intervention that visually confirmed medication ingestion, thereby potentially reducing buprenorphine misuse and diversion and improving medication adherence. Patients with OUD, who were not currently prescribed buprenorphine, were recruited. All patients received buprenorphine, a study provided smartphone, weekly Cognitive Behavioral Therapy (CBT), and twice weekly urine screens. The experimental group video recorded themselves taking the medication and these videos were automatically sent daily to the clinical research staff who observed the dosing. This allowed for both the patients and clinical staff to find convenient times to do the tasks and improved clinic office workflow. The attention control (AC) group did not record their medication dosing.