Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.

BACKGROUND: Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD. METHODS: The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population. DISCUSSION: Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population. TRIAL REGISTRATION: Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.

"I'm Clean and Sober, But Not Necessarily Free": Perceptions of Buprenorphine Among Patients in Long-Term Treatment.

BACKGROUND: Patients receiving buprenorphine for the treatment of opioid use disorder (OUD) experience a roughly 50% reduction in mortality risk relative to those not receiving medication. Longer periods of treatment are also associated with improved clinical outcomes. Despite this, patients often express desires to discontinue treatment and some view taper as treatment success. Little is known about the beliefs and medication perspectives of patients engaged in long-term buprenorphine treatment that may underlie motivations to discontinue. METHODS: This study was conducted at the VA Portland Health Care System (2019-2020). Qualitative interviews were conducted with participants prescribed buprenorphine for ≥2 years. Coding and analysis were guided by directed qualitative content analysis. RESULTS: Fourteen patients engaged in office-based buprenorphine treatment completed interviews. While patients expressed strong enthusiasm for buprenorphine as a medication, the majority expressed the desire to discontinue, including patients actively tapering. Motivations to discontinue fell into 4 categories. First, patients were troubled by perceived side effects of the medication, including effects on sleep, emotion, and memory. Second, patients expressed unhappiness with being "dependent" on buprenorphine, framed in opposition to personal strength/independence. Third, patients expressed stigmatized beliefs about buprenorphine, describing it as "illicit," and associated with past drug use. Finally, patients expressed fears about buprenorphine unknowns, including potential long-term health effects and interactions with medications required for surgery. CONCLUSIONS: Despite recognizing benefits, many patients engaged in long-term buprenorphine treatment express a desire to discontinue. Findings from this study may help clinicians anticipate patient concerns and can be used to inform shared decision-making conversations regarding buprenorphine treatment duration.

Perioperative Management of Buprenorphine/Naloxone in a Large, National Health Care System: a Retrospective Cohort Study.

BACKGROUND: Medication for opioid use disorder, including buprenorphine and methadone, is considered the gold standard treatment for opioid use disorder (OUD). As the number of patients receiving buprenorphine has grown, clinicians increasingly care for patients prescribed buprenorphine who present for surgery and require management of perioperative pain. OBJECTIVE: To describe practice patterns of perioperative and post-surgical use of buprenorphine among patients prescribed buprenorphine for OUD who experience major surgery. DESIGN: Retrospective cohort study utilizing data from the VA Corporate Data Warehouse (CDW), a national repository of patient-level data. Data not accessible in CDW, including clinical instructions to patients to modify buprenorphine dose, were accessed via chart review. PARTICIPANTS: National sample of patients receiving care through the Veterans Health Administration. MAIN MEASURES: We report descriptive statistics on the incidence of buprenorphine dose hold prior to, during, and immediately following surgery, as well as post-surgical outcomes. Multivariable logistic regression identified socio-demographic and clinical characteristics associated with perioperative hold. KEY RESULTS: Our final sample comprised 183 patients, the majority of whom were white and male. Most patients (66%) experienced a perioperative buprenorphine dose hold: during the pre-operative, day of surgery, and post-operative periods, 40%, 62%, and 55% of patients had buprenorphine held. Buprenorphine dose hold was less likely for patients who had experienced homelessness/housing insecurity in the year prior to surgery (aOR = 0.25; 95% CI 0.10-0.61) as well as patients residing in rural areas (aOR=0.29; 0.12-0.68). Within the 12-month period following surgery, 122 patients (67%) were retained on buprenorphine, 10 patients (5.5%) had experienced an overdose, and 15 (8.2%) had died. CONCLUSIONS: We identified high rates of perioperative buprenorphine dose holds. As holding buprenorphine perioperatively does not align with emerging clinical recommendations and carries significant risks, educational campaigns or other provider-targeted interventions may be needed to ensure patients with OUD receive recommended care.

Marijuana Use Is Not Associated With Changes in Opioid Prescriptions or Pain Severity Among People Living With HIV and Chronic Pain.

BACKGROUND: People living with HIV (PLWH) commonly report marijuana use for chronic pain, although there is limited empirical evidence to support its use. There is hope that marijuana may reduce prescription opioid use. Our objective was to investigate whether marijuana use among PLWH who have chronic pain is associated with changes in pain severity and prescribed opioid use (prescribed opioid initiation and discontinuation). METHODS: Participants completed self-report measures of chronic pain and marijuana use at an index visit and were followed up for 1 year in the Center for AIDS Research Network of Integrated Clinical Systems (CNICS). Self-reported marijuana use was the exposure variable. Outcome variables were changes in pain and initiation or discontinuation of opioids during the study period. The relationship between exposure and outcomes was assessed using generalized linear models for pain and multivariable binary logistic regression models for opioid initiation/discontinuation. RESULTS: Of 433 PLWH and chronic pain, 28% reported marijuana use in the past 3 months. Median pain severity at the index visit was 6.3/10 (interquartile range 4.7-8.0). Neither increases nor decreases in marijuana use were associated with changes in pain severity, and marijuana use was not associated with either lower odds of opioid initiation or higher odds of opioid discontinuation. CONCLUSIONS: We did not find evidence that marijuana use in PLWH is associated with improved pain outcomes or reduced opioid prescribing. This suggests that caution is warranted when counseling PLWH about potential benefits of recreational or medical marijuana.

Development of an Algorithm to Identify Cannabis Urine Drug Test Results within a Multi-Site Electronic Health Record System.

With the rapid changes in the legalization of cannabis in the U.S., there is an urgent need to understand clinical outcomes and processes of care among patients who use cannabis, particularly among patients with chronic pain who are high utilizers of cannabis. Electronic health records (EHRs) are a common and convenient mechanism for examining processes of care; however, there is not an indication for cannabis use that does not meet criteria for a diagnostic disorder. We used urine drug test (UDT) results identified through EHRs to identify patients with confirmed cannabis use. We developed and tested an algorithm to identify outcomes of UDT results for cannabis because there is wide variability in reporting methodology, including in multi-site health systems. Among all patients receiving care in the Department of Veterans Affairs (VA) who were prescribed long-term opioid therapy for chronic pain, we identified a random sample who completed UDT for cannabis. Through an iterative process, we developed an algorithm to identify UDT cannabis results. Manual review of EHR data was conducted to verify accuracy of UDT results. The final UDT algorithm correctly identified 99% of cannabis positive UDT results and 100% of cannabis negative UDT results among 200 randomly sampled patients. Study findings suggest a high degree of accuracy for using an algorithm to identify samples of patients with positive cannabis UDT results across multiple institutions with disparate UDT reporting practices. The methodology for testing this algorithm is feasible and may be applied to other multi-site health systems.

An examination of direct and indirect effects of exposure and attention to health media on intentions to avoid unprotected sun exposure.

Skin cancer is the most commonly diagnosed cancer in the United States, accounting for more than 2 million diagnoses and more than 9,000 deaths annually. A regional online survey of students enrolled at institutions of higher education (N = 1,251) examined (a) associations between health media use and intentions to avoid unprotected sun exposure and (b) theoretically derived health behavior constructs that may mediate the relationship between media use and individuals' decisions to avoid unprotected sun exposure. Individuals with greater exposure and attention to health information in television, magazines, and newspapers had higher intentions to avoid unprotected sun exposure. Multiple mediation models indicated that health behavior constructs collectively mediated the relationship between television use and sun-protective behavioral intentions. Both cumulative and specific indirect mediating effects were observed for the relationship between magazine use and sun-protective behavioral intentions. However, the direction of effects was opposite to the hypothesized direction, due primarily to the association of magazine use with less favorable attitudes about sun protection and reduced behavioral control to avoid unprotected sun exposure. This study provides preliminary evidence for the interrelationships among media use, internal psychological states and cognitions, and health behavior decision making. Future studies should further explicate the mediating processes that account for the relationships between media and health behavior.