Literature Collection

Background: A scoping review was conducted to examine the breadth of evidence related to telehealth innovations being utilized in the treatment of opioid use disorder (OUD) with buprenorphine and its effect on patient outcomes and health care delivery. Materials and Methods: The authors systematically searched seven databases and websites for peer-reviewed and gray literature related to telehealth solutions for buprenorphine treatment published between 2008 and March 18, 2021. Two reviewers screened titles and abstracts for articles that met the inclusion criteria, according to the scoping review study protocol. The authors included studies if they specifically examined telehealth interventions aimed at improving access to and usage of buprenorphine for OUD. Results: After screening 371 records, the authors selected 69 for full review. These studies examined the effect of telehealth on patient satisfaction, treatment retention rates, and buprenorphine accessibility and adherence. Conclusion: According to the reviewed literature, incorporation of telehealth technology with medication-assisted treatment for OUD is associated with higher patient satisfaction, comparable rates of retention, an overall reduction in health care costs, and an increase in both access to and usage of buprenorphine. This has been made possible through the expansion of telehealth technologies and a substantial push toward relaxed federal guidelines, both of which were quickly escalated in response to the COVID-19 pandemic. Future research is needed to fully quantify the effect of these factors; however, the results appear promising thus far and should urge policymakers to consider making these temporary policy changes permanent.

BACKGROUND: Office-based buprenorphine treatment of opioid use disorder (OUD) does not typically include in-person directly observed therapy (DOT), potentially leading to non-adherence. Video DOT technologies may safeguard against this issue and thus enhance likelihood of treatment success. We describe the rationale and protocol for the Trial of Adherence Application for Buprenorphine treatment (TAAB) study, a pilot randomized controlled trial (RCT) to evaluate the effects of video DOT delivered via a smartphone app on office-based buprenorphine treatment outcomes, namely illicit opioid use and retention. METHODS: Participants will be recruited from office-based opioid addiction treatment programs in outpatient clinics at two urban medical centers and randomized to either video DOT (intervention) delivered via a HIPAA-compliant, asynchronous, mobile health (mHealth) technology platform, or treatment-as-usual (control). Eligibility criteria are: 18 years or older, prescribed sublingual buprenorphine for a cumulative total of 28 days or less from the office-based opioid treatment program, and able to read and understand English. Patients will be considered ineligible if they are unable or unwilling to use the intervention, provide consent, or complete weekly study visits. All participants will complete 13 in-person weekly visits and be followed via electronic health record data capture at 12- and 24-weeks post-randomization. Data gathered include the following: demographics; current and previous treatment for OUD; self-reported diversion of prescribed buprenorphine; status of their mental and physical health; and self-reported lifetime and past 30-day illicit substance use. Participants provide urine samples at each weekly visit to test for illicit drugs and buprenorphine. The primary outcome is percentage of weekly urines that are negative for opioids over the 12-weeks. The secondary outcome is engagement in treatment at week 12. DISCUSSION: Video DOT delivered through mHealth technology platform offers possibility of improving patients' buprenorphine adherence by providing additional structure and accountability. The TAAB study will provide important preliminary estimates of the impact of this mHealth technology for patients initiating buprenorphine, as well as the feasibility of study procedures, thus paving the way for further research to assess feasibility and generate preliminary data for design of a future Phase III trial. Trial Registration ClinicalTrails.gov, NCT03779997, Registered on December 19, 2018.

Weekly and monthly CAM2038 (Brixadi(®)) extended-release subcutaneous buprenorphine (XR bup) has been available in Europe and Australia for several years and was approved by the Food and Drug Administration in May 2023. Little is known about the clinical experience of patients and providers using this new medication during prenatal care. Two cases of pregnant persons with opioid use disorder receiving weekly XR bup in an ongoing randomized multi-site outpatient clinical trial are presented along with a brief review of the pharmacology and literature on XR bup formulations. The cases in pregnancy illustrate how treatment with the weekly formulation is initiated including how to make dose adjustments, which may be necessary given the longer half-life; it takes 1 month to achieve steady state. Injection site pain with medication administration was time limited and managed readily. Other injection site reactions experienced included subcutaneous erythema and induration that was delayed in onset and typically mild, resolving with minimal intervention. Delivery management and breastfeeding recommendations while on weekly XR bup were not different compared to sublingual buprenorphine (SL bup). Weekly XR bup is a new treatment for opioid use disorder that may be used in the obstetric population. Obstetric and addiction medicine clinicians should be aware of this new formulation as its use is expected to increase.

Combination buprenorphine-naloxone is a cornerstone of outpatient treatment for substance use disorder, and is more widely accessible in primary care. Because oral buprenorphine has been diverted and abused for its euphoric properties, a combination formulation was developed and will trigger withdrawal symptoms if injected IV.

Background: Opioid dependence during pregnancy is associated with increased risk of low birthweight, neonatal mortality, and maternal complications. Methadone or buprenorphine maintenance therapy can prevent the effects of repeated withdrawals on the fetus and improve outcomes for infants and mothers. Method: This report uses the combined 2007 to 2012 National Surveys on Drug Use and Health (NSDUHs), the 2012 Treatment Episode Data Set (TEDS), and the 2012 National Survey of Substance Abuse Treatment Services (N-SSATS) to examine opioid misuse and treatment among women of childbearing age (aged 15 to 44). Results: An annual average of 21,000 pregnant women aged 15 to 44 misused opioids in the past month. Among pregnant women aged 15 to 44, those who were younger and those living below the federal poverty level were more likely than other pregnant women to be past month opioid misusers. Of the pregnant female treatment admissions, 22.9 percent reported heroin use and 28.1 percent reported nonheroin opioid misuse. About half of pregnant female admissions with heroin use had methadone or buprenorphine as a part of their treatment plan compared with less than one-quarter of nonpregnant female admissions with heroin use. For female admissions aged 15 to 44 reporting nonheroin opioid misuse, rates for having methadone or buprenorphine as a part of their treatment plan were comparatively lower. About 13 percent of outpatient-only substance use treatment facilities and residential treatment facilities offered a special program or group for pregnant/postpartum women. Between 61 and 79 percent of facilities that offered specialized programs or groups to pregnant or postpartum women accepted Medicaid as a form of payment. Conclusion: The findings suggest that outreach and educational resources targeting younger pregnant women and women living below the federal poverty level about the dangers of misusing prescription pain relievers may be especially beneficial. The health insurance gap among pregnant treatment admissions suggests that these women may need assistance in navigating the health insurance and health service opportunities provided by the Affordable Care Act to ensure critical access to the health care system.