Clinical trial NCT03586466: Improving Office Based Treatment of Opioid Use Disorder With Technology
Official title: Pilot for Improved Office Based Treatment of Opioid-Dependence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid-use Disorder
Keywords: opioid abuse
opioid dependence
medication assisted treatment
opioids
buprenorphine
buprenorphine/naloxone
MedicaSafe
Lead sponsor: MedicaSafe, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Friends Research Institute, Inc.
First posted: 2018-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.

Detailed description: The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that more than 12 million Americans misuse prescription opioids for nonmedical purposes annually. The costs of this problem are substantial, both to individuals and society: total costs of prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise. In spite of this, the availability and acceptance of treatment with medications has not kept pace with the spread of the epidemic.

Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue (misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence with a prescribed regimen has been shown to correlate with treatment success, and conversely poor patient compliance, commonly documented, correlates with poor outcomes. Studies have demonstrated that with B/N specifically, compliance is predictive of both relapse and treatment retention. Relapse events are costly in terms of total healthcare expenditures (around $15,000 per patient), and personally - upwards of 800,000 years of potential life lost before the age of 65 in the US alone.

This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral medication dispenser and secure pill cartridges coupled with an online platform. The system is programmed with a treatment plan to allow for the dispensation of medications in the right dose at the right time. Dispensation is recorded and collated in treatment reports to track patient adherence to their regimen. The project intends to ameliorate issues associated with MAT by curbing the negative effects of medication nonadherence and diversion, while simultaneously increasing provider awareness of patient behaviors and needs.

Patients aged 18-65 (inclusive) will be enrolled at Friends Research Institute in a field trial. Patients will be maintained on a stable dose of B/N, and randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at baseline, and then every 2 weeks following study initiation.

Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18 and 65 years old
* Be able to provide informed consent
* Be English-speaking
* Have consistent phone and/or internet access
* Deemed by physician as medically, psychiatrically, and otherwise appropriate for buprenorphine therapy
* Maintained on a stable B/N dose

Exclusion Criteria:

* Be younger than 18 or older than 65 years of age
* Chronic pain
* Be non-English speaking
* Be unable to complete informed consent
* Be pregnant

Primary outcomes:
measure: Compliance
timeFrame: Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
Secondary outcomes:
measure: Urine Drug Screens
timeFrame: Bi-weekly, across the 12-week participation period.
measure: Relapse
timeFrame: Examined bi-weekly across the 12-week participation period.
Other outcomes:
measure: Compliance - Week 4
timeFrame: Week 4 of the 12-week participation period.
measure: Compliance - Week 8
timeFrame: Week 8 of the 12-week participation period.
Locations:
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
Study officials:
affiliation: MedicaSafe, Inc.
name: Anand Mattai, MD
role: PRINCIPAL_INVESTIGATOR
References: