Dataset Information

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.

ABSTRACT:

Objectives

To evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253).

Methods

Secondary analysis of an RCT including 170 adults meeting DSM-IV criteria for OUD. Participants were randomized to 12-weeks of treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach. TAU consisted of buprenorphine maintenance therapy, 30 min biweekly clinician interaction, and abstinence-based contingency management. Primary endpoints were treatment retention and abstinence (negative urine drug screen) during weeks 9-12 of treatment. Safety was assessed by evaluating adverse events.

Results

Participants randomized to TAU plus a digital therapeutic had significantly greater odds of opioid abstinence during weeks 9-12 compared to TAU: 77.3 versus 62.1%, respectively (p=.02), OR 2.08, 95% CI 1.10-3.95. The risk of patients leaving treatment was significantly lower in the digital therapeutic group (HR 0.49, 95% CI 0.26-0.92). No significant difference was observed in the rate of adverse events between groups (p=.42).

Conclusions

A prescription digital therapeutic (PDT) in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with treatment as usual.

SUBMITTER: Maricich YA

PROVIDER: S-EPMC8666102 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundHome-based (unsupervised) buprenorphine initiation is considered safe and effective, yet many patients report barriers to successful treatment initiation. Prescription digital therapeutics (PDTs) are software-based disease treatments regulated by the US Food and Drug Administration (FDA). The reSET-O PDT was authorized by the FDA in 2018 and delivers behavioral treatment for individuals receiving buprenorphine for opioid use disorder (OUD). A prototype PDT (PEAR-002b) designed for use with reSET-O was developed to assist in unsupervised buprenorphine initiation.ObjectiveThe primary objective of this pilot study is to evaluate the acceptability of PEAR-002b in individuals with OUD who use it to support buprenorphine initiation, their unsupervised buprenorphine initiation success rate, and their medication adherence.MethodsTen adults with OUD will be recruited for acceptability and feasibility testing. Outcomes will be assessed using week-1 visit attendance, participant interviews and satisfaction surveys, and urine drug screening (UDS). Three tools will be used in the study: PEAR-002b, reSET-O, and EmbracePlus. PEAR-002b includes a new set of features designed for use with reSET-O. The mechanism of action for the combined PEAR-002b and reSET-O treatment is a program of medication dosing support during week 1 of the initiation phase, cognitive behavioral therapy, and contingency management. During the medication initiation phase, participants are guided through a process to support proper medication use. PEAR-002b advises them when to take their buprenorphine based on provider inputs (eg, starting dose), self-reported substance use, and self-reported withdrawal symptoms. This study also administers the EmbracePlus device, a medical-grade smartwatch, to pilot methods for collecting physiologic data (eg, heart rate and skin conductance) and evaluate the device's potential for use along with PDTs that are designed to improve OUD treatment initiation. Home buprenorphine initiation success will be summarized as the proportion of participants attending the post-buprenorphine initiation visit (week 1) and the proportion of participants who experience buprenorphine initiation-related adverse events (eg, precipitated withdrawal). Acceptability of PEAR-002b will be evaluated based on individual participants' ratings of ease of use, satisfaction, perceived helpfulness, and likelihood of recommending PEAR-002b. Medication adherence will be evaluated by participant self-report data and confirmed by UDS. UDS data will be summarized as the mean of individual participants' proportion of total urine samples testing positive for buprenorphine or norbuprenorphine over the 4-week study.ResultsThis project was funded in September 2019. As of September 2022, participant enrollment is ongoing.ConclusionsThis is the first study to our knowledge to develop a PDT that assists with unsupervised buprenorphine initiation with the intent to better support patients and prescribers during this early phase of treatment. This pilot study will assess the acceptability and utility of a digital therapeutic to assist individuals with OUD with unsupervised buprenorphine initiation.Trial registrationClinicalTrials.gov NCT05412966; https://clinicaltrials.gov/ct2/show/NCT05412966.International registered report identifier (irrid)PRR1-10.2196/43122.

Project description:OBJECTIVE:Although buprenorphine treatment reduces risk of overdose and death in opioid use disorder, most patients discontinue treatment within a few weeks or months. Adverse health outcomes following buprenorphine discontinuation were compared among patients who were successfully retained beyond 6 months of continuous treatment, a minimum treatment duration recently endorsed by the National Quality Forum. METHODS:A retrospective longitudinal cohort analysis was performed using the MarketScan multistate Medicaid claims database (2013-2017), covering 12 million beneficiaries annually. The sample included adults (18-64 years of age) who received buprenorphine continuously for ?180 days by cohorts retained for 6-9 months, 9-12 months, 12-15 months, and 15-18 months. For outcome assessment in the postdiscontinuation period, patients had to be continuously enrolled in Medicaid for 6 months after buprenorphine discontinuation. Primary adverse outcomes included all-cause emergency department visits, all-cause inpatient hospitalizations, opioid prescriptions, and drug overdose (opioid or non-opioid). RESULTS:Adverse events were common across all cohorts, and almost half of patients (42.1%-49.9%) were seen in the emergency department at least once. Compared with patients retained on buprenorphine for 6-9 months (N=4,126), those retained for 15-18 months (N=931) had significantly lower odds of emergency department visits (odds ratio=0.75, 95% CI=0.65-0.86), inpatient hospitalizations (odds ratio=0.79, 95% CI=0.64-0.99), and filling opioid prescriptions (odds ratio=0.67, 95% CI=0.56-0.80) in the 6 months following discontinuation. Approximately 5% of patients across all cohorts experienced one or more medically treated overdoses. CONCLUSIONS:Risk of acute care service use and overdose were high following buprenorphine discontinuation irrespective of treatment duration. Superior outcomes became significant with treatment duration beyond 15 months, although rates of the primary adverse outcomes remained high.

Project description:ImportanceExpanding treatment for opioid addiction has been recognized as an essential component of a comprehensive national response to the opioid epidemic. The Drug Addiction Treatment Act and its amendments attempted to improve access to treatment by involving office-based physicians in the provision of buprenorphine treatment.ObjectivesTo estimate the association of availability of buprenorphine-waivered physicians with buprenorphine treatment use and, secondarily, with prescription opioid use among Medicaid enrollees.Design, setting, and participantsThis economic evaluation study used state-level panel data analysis to estimate the association between the number of buprenorphine-waivered physicians and the Medicaid-covered buprenorphine prescribing rate and opioid prescribing rate among Medicaid fee-for-service and managed care enrollees throughout the United States between January 1, 2011, and December 31, 2016.Main outcomes and measuresBuprenorphine prescribing rate and opioid prescribing rate, measured as the number of buprenorphine prescriptions and opioid prescriptions covered by Medicaid on a quarterly basis per 1000 enrollees.ResultsThe sample included 1059 quarterly observations. Two additional 100-patient-waivered physicians per 1 000 000 residents (approximately a 10% increase) were associated with an increase in the quarterly number of Medicaid-covered buprenorphine prescriptions of 0.46 (95% CI, 0.24-0.67) per 1000 enrollees and a reduction in the quarterly number of opioid prescriptions of 1.01 (95% CI, -1.87 to -0.15) per 1000 enrollees. Furthermore, 5 additional 30-patient-waivered physicians per 1 000 000 residents (approximately a 10% increase) were associated with an increase in the quarterly number of Medicaid-covered buprenorphine prescriptions of 0.37 (95% CI, 0.22-0.52) per 1000 enrollees and a reduction in the quarterly number of opioid prescriptions of 0.96 (95% CI, -1.85 to -0.07) per 1000 enrollees. A 10% increase in the number of buprenorphine-waivered physicians was associated with an approximately 10% increase in the Medicaid-covered buprenorphine prescribing rate and a 1.2% reduction in the opioid prescribing rate.Conclusions and relevanceExpanding capacity for buprenorphine treatment holds the potential to improve access to opioid addiction treatment, which may further reduce prescription opioid use and slow the ongoing opioid epidemic in the United States.

Project description:ImportanceAlthough substantial evidence supports buprenorphine for treatment of opioid use disorder (OUD) in controlled trials, prospective study of patient outcomes in clinical implementation of emergency department (ED) buprenorphine treatment is lacking.ObjectiveTo examine the association between buprenorphine treatment in the ED and follow-up engagement in OUD treatment 1 month later.Design, setting, and participantsThis multisite cohort study was conducted in 7 California EDs participating in a statewide implementation project to improve access to buprenorphine treatment. The study population included ED patients aged at least 18 years identified with OUD between April 1, 2021, and June 30, 2022. Data analysis was performed in October 2023.ExposureAll participants were offered buprenorphine treatment for OUD (either in ED administration, prescription, or both), the uptake of which was examined as the exposure of interest.Main outcomes and measuresThe primary outcome was engagement in OUD treatment 30 days after the ED visit, determined by patient report or clinical documentation. The association of ED buprenorphine treatment with subsequent OUD treatment engagement was estimated using hierarchical generalized linear models.ResultsThis analysis included 464 ED patients with OUD. Their median age was 36.0 (IQR, 29.0-38.7) years, and most were men (343 [73.9%]). With regard to race and ethnicity, 64 patients (13.8%) self-identified as non-Hispanic Black, 183 (39.4%) as Hispanic, and 185 as non-Hispanic White (39.9%). Most patients (396 [85.3%]) had Medicaid insurance, and more than half (262 [57.8%]) had unstable housing. Self-reported fentanyl use (242 [52.2%]) and a comorbid mental health condition (328 [71.5%]) were common. Interest in buprenorphine treatment was high: 398 patients (85.8%) received buprenorphine treatment; 269 (58.0%) were administered buprenorphine in the ED and 339 (73.1%) were prescribed buprenorphine. With regard to OUD treatment engagement at 30 days after the ED visit, 198 participants (49.7%) who received ED buprenorphine treatment remained engaged compared with 15 participants (22.7%) who did not receive ED buprenorphine treatment. An association of ED buprenorphine treatment with subsequent OUD treatment engagement at 30 days was observed (adjusted risk ratio, 1.97 [95% CI, 1.27-3.07]).Conclusions and relevanceThe findings of this cohort study suggest that among patients with OUD presenting to EDs implementing low-threshold access to medications for OUD, buprenorphine treatment was associated with a substantially higher likelihood of follow-up treatment engagement 1 month later. Future research should investigate techniques to optimize both the uptake and effectiveness of buprenorphine initiation in low-threshold settings such as the ED.

Project description:ImportanceBetween 1997 and 2017, the United States saw increases in nonmedical prescription opioid use and its consequences, as well as changes in marijuana policies. Ecological-level research hypothesized that medical marijuana legalization may reduce prescription opioid use by allowing medical marijuana as an alternative.ObjectivesTo investigate the association of state-level medical marijuana law enactment with individual-level nonmedical prescription opioid use and prescription opioid use disorder among prescription opioid users and to determine whether these outcomes varied by age and racial/ethnic groups.Design, setting, and participantsThis cross-sectional study used restricted data on 627 000 individuals aged 12 years and older from the 2004 to 2014 National Survey on Drug Use and Health, a population-based survey representative of the civilian population of the United States. Analyses were completed from March 2018 to May 2018.ExposuresTime-varying indicator of state-level medical marijuana law enactment (0 = never law enactment, 1 = before law enactment, and 2 = after law enactment).Main outcomes and measuresPast-year nonmedical prescription opioid use and prescription opioid use disorder among prescription opioid users. Odds ratios of nonmedical prescription opioid use and prescription opioid use disorder comparing the period before and after law enactment were presented overall, by age and racial/ethnic group, and adjusted for individual- and state-level confounders.ResultsThe study sample included 627 000 participants (51.51% female; 9.88% aged 12-17 years, 13.30% aged 18-25 years, 14.30% aged 26-34 years, 25.02% aged 35-49 years, and 37.50% aged ≥50 years; the racial/ethnic distribution was 66.97% non-Hispanic white, 11.83% non-Hispanic black, 14.47% Hispanic, and 6.73% other). Screening and interview response rates were 82% to 91% and 71% to 77%, respectively. Overall, there were small changes in nonmedical prescription opioid use prevalence after medical marijuana law enactment (4.32% to 4.86%; adjusted odds ratio, 1.13; 95% CI, 1.06-1.20). Prescription opioid use disorder prevalence among prescription opioid users decreased slightly after law enactment, but the change was not statistically significant (15.41% to 14.76%; adjusted odds ratio, 0.95; 95% CI, 0.81-1.11). Outcomes were similar when stratified by age and race/ethnicity.Conclusions and relevanceThis study found little evidence of an association between medical marijuana law enactment and nonmedical prescription opioid use or prescription opioid use disorder among prescription opioid users. Further research should disentangle the potential mechanisms through which medical marijuana laws may reduce opioid-related harm.