An uncontrolled pilot trial of a buprenorphine dispensing device to enhance outpatient treatment for opioid use disorder.

BACKGROUND

Buprenorphine is an efficacious and widely used pharmacological treatment for OUD; however, barriers to daily adherence and regular monitoring limit its overall effectiveness. The purpose of this study was to test the feasibility of an investigational medication dispensing device to promote adherence and monitoring of daily sublingual buprenorphine for individuals with opioid use disorder (OUD).

METHODS

This single-arm pilot study recruited (N=25) adults aged 18-65 who were prescribed sublingual buprenorphine for OUD from two outpatient treatment centers in Maryland, USA. All participants were assigned to the investigational buprenorphine dispensing device (MedicaSafe) on top of usual care for a 4-week intervention period. Devices were individually programed to dispense the daily prescribed dosage and given to participants at a baseline visit after providing informed consent. Follow-up visits occurred at 2-weeks and 4-weeks (end of intervention) to collect a urine drug screen (UDS) and self-report questionnaires on opioid use, opioid, craving, global impression of change, and treatment satisfaction. Data from the devices were synced to an online portal resulting in a detailed timeline of the medication dispensation.

RESULTS

Participants were mostly White, used heroin, had mean age of 34.1 years, and had been maintained on buprenorphine for an average of 48 weeks prior to study participation. The primary outcome of buprenorphine adherence rate was 92% and was calculated using data from device dispensation logs. Overall patient satisfaction with the device was M=4.67 on a 0-6 scale with higher scores indicating greater satisfaction.

CONCLUSIONS

Overall, the MedicaSafe platform is a feasible and innovative approach for individuals on daily sublingual buprenorphine for OUD with the potential to improve buprenorphine adherence.