Nurse Care Management for Opioid Use Disorder Treatment: The PROUD Cluster Randomized Clinical Trial.

Importance: Few primary care (PC) practices treat patients with medications for opioid use disorder (OUD) despite availability of effective treatments. Objective: To assess whether implementation of the Massachusetts model of nurse care management for OUD in PC increases OUD treatment with buprenorphine or extended-release injectable naltrexone and secondarily decreases acute care utilization. Design, Setting, and Participants: The Primary Care Opioid Use Disorders Treatment (PROUD) trial was a mixed-methods, implementation-effectiveness cluster randomized clinical trial conducted in 6 diverse health systems across 5 US states (New York, Florida, Michigan, Texas, and Washington). Two PC clinics in each system were randomized to intervention or usual care (UC) stratified by system (5 systems were notified on February 28, 2018, and 1 system with delayed data use agreement on August 31, 2018). Data were obtained from electronic health records and insurance claims. An implementation monitoring team collected qualitative data. Primary care patients were included if they were 16 to 90 years old and visited a participating clinic from up to 3 years before a system's randomization date through 2 years after. Intervention: The PROUD intervention included 3 components: (1) salary for a full-time OUD nurse care manager; (2) training and technical assistance for nurse care managers; and (3) 3 or more PC clinicians agreeing to prescribe buprenorphine. Main Outcomes and Measures: The primary outcome was a clinic-level measure of patient-years of OUD treatment (buprenorphine or extended-release injectable naltrexone) per 10 000 PC patients during the 2 years postrandomization (follow-up). The secondary outcome, among patients with OUD prerandomization, was a patient-level measure of the number of days of acute care utilization during follow-up. Results: During the baseline period, a total of 130 623 patients were seen in intervention clinics (mean [SD] age, 48.6 [17.7] years; 59.7% female), and 159 459 patients were seen in UC clinics (mean [SD] age, 47.2 [17.5] years; 63.0% female). Intervention clinics provided 8.2 (95% CI, 5.4-∞) more patient-years of OUD treatment per 10 000 PC patients compared with UC clinics (P = .002). Most of the benefit accrued in 2 health systems and in patients new to clinics (5.8 [95% CI, 1.3-∞] more patient-years) or newly treated for OUD postrandomization (8.3 [95% CI, 4.3-∞] more patient-years). Qualitative data indicated that keys to successful implementation included broad commitment to treat OUD in PC from system leaders and PC teams, full financial coverage for OUD treatment, and straightforward pathways for patients to access nurse care managers. Acute care utilization did not differ between intervention and UC clinics (relative rate, 1.16; 95% CI, 0.47-2.92; P = .70). Conclusions and Relevance: The PROUD cluster randomized clinical trial intervention meaningfully increased PC OUD treatment, albeit unevenly across health systems; however, it did not decrease acute care utilization among patients with OUD. Trial Registration: ClinicalTrials.gov Identifier: NCT03407638.

Utility of a brief assessment of opioid demand among post-discharge trauma care patients.

Opioid misuse and opioid-related death are a growing public health concern. One population of interest is recent trauma and/or surgery patients, who are at increased risk of developing an opioid use disorder (OUD). Although a variety of assessments have been developed to screen for risk of opioid misuse, each has limitations and prediction needs improvement. One promising measure is drug demand, a behavioral economic measure assessing drug consumption at different price points. In the current proposal, we assessed the utility of a brief assessment of opioid demand. Demand and various pain-related self-report measures among trauma-surgery patients (N = 103) were assessed at 4 weeks post-discharge. Opioid demand was significantly associated with self-report measures of pain and amount of morphine milligram equivalents (MME) received during the hospital stay. The current result support the utility of the opioid demand as an adjunctive and complementary measure to assess risk of opioid misuse. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

A sequential multiple assignment randomized trial for cocaine cessation and relapse prevention: Tailoring treatment to the individual.

Drug addiction is a chronic, devastating, but treatable disorder. A core principle of drug addiction treatment states that no single treatment is appropriate for everyone (NIDA, 2012); treatments need to adjust based on patient characteristics and response in order to be maximally effective. For cocaine use disorders (CUD), specifically, the most potent intervention currently available for initiating abstinence is behavior therapy using contingency management (CM) procedures, with early cessation being a robust predictor of future abstinence. This raises two key questions for treatment development research: First, can we significantly improve initial CM response rates with targeted adjunctive interventions? Second, for individuals who fail to achieve initial abstinence with CM, is pharmacotherapy an effective augmentation strategy? This paper describes how a sequential, multiple assignment, randomized trial (SMART) design has advantages over a fixed-intervention approach when it comes to collecting data needed to answer both questions. The first aim will examine whether Acceptance and Commitment Therapy (ACT) in combination with CM increases initial abstinence response rates (i.e., 2 consecutive weeks of cocaine-negative urine screens). The second aim will examine whether ACT+CM in combination with modafinil promotes abstinence achievement in initial non-responders. Results are expected to inform how we tailor treatment of CUD to maximize outcomes.

The role of avoidance and inflexibility in characterizing response to contingency management for cocaine use disorders: A secondary profile analysis.

Contingency management (CM) is a reinforcement-based approach that provides tangible rewards for objectively verified drug abstinence. CM is the most effective available behavioral intervention for cocaine use disorders; however, response to CM is variable, with significant rates of nonresponse. In the present investigation, we conducted a secondary profile analysis to identify potentially modifiable cognitive-affective characteristics associated with CM response (abstinence vs. continued use) preceding a pharmacotherapy trial for cocaine dependence. Ninety-nine cocaine-dependent, treatment-seeking adults participated in a 4-week baseline CM procedure using high-value vouchers for submission of cocaine-negative urines. Separate profiles for responders and the nonresponders were established using standardized mean scores on relevant pretreatment measures of negative affect, experiential avoidance, cocaine withdrawal/craving, and impulsivity. Results indicated no differences between responder subgroups on baseline levels of negative affect, withdrawal/craving, or impulsivity; however, CM nonresponders, relative to responders, reported significantly higher levels of avoidance and behavioral inflexibility (p < .01) in the context of distressing cocaine-related thoughts, feelings, and bodily sensations. These data suggest that emotion regulation skills may serve as a therapeutic strategy for enhancing response to CM for cocaine use disorders. (PsycINFO Database Record

Impact of a motivational intervention on mechanisms of change in low-income pregnant smokers.

Numerous smoking cessation interventions targeting pregnant women have been developed and tested. An overall increase in smoking cessation is indicated, yet quit rates are modest and variable. Although efficacious with other substance abuse populations, motivational interviewing (MI) interventions with pregnant smokers have resulted in marginal outcomes. Examining treatment mechanisms affected by MI interventions may assist in understanding negative results and in developing more innovative and effective interventions. This study assessed the impact of an MI intervention on transtheoretical (TTM)-based mechanisms of change in low-income pregnant smokers (N = 54). Repeated measures analyses indicated that relative to usual care (UC), pregnant smokers who received MI reported a greater increase in confidence to abstain from smoking, a decrease in temptation to smoke, and a decrease in level of depression. However, the MI intervention was not associated with forward progression in the stages of change. More intensive motivational and cognitive-behavioral interventions demonstrated effective in nonpregnant, smoking populations, with more frequent sessions separate from prenatal visits, are recommended to further increase smoking cessation rates among low-income pregnant smokers.

Baby's Breath II protocol development and design: a secondhand smoke exposure prevention program targeting infants discharged from a neonatal intensive care unit.

BACKGROUND: Over one-third of all children live with at least one parent who smokes cigarettes, which is associated with compromised child health. The impact of secondhand smoke exposure (SHSe) in medically fragile infants born prematurely is likely to be much higher. The Baby's Breath II study tests whether a hospital-initiated, motivational-enhancement program will result in less SHSe relative to conventional care in high-risk, low birthweight (LBW) infants discharged from a neonatal intensive care unit (NICU). The design and protocol for the ongoing BBII trial is described. METHODS/DESIGN: Eligible participants are: (1) primary caregivers (typically mothers) of NICU infants who were born at LBW (<2500g) or ventilated for more than 12h; and (2) who smoke or live with at least one smoker. This randomized controlled trial has two conditions: Motivational interviewing plus incentives (MI+) and conventional care (CC). MI+ participants receive two hospital-based and two home-based counseling sessions, as well as incentives (i.e., prize-based draws) for (a) intervention attendance and (b) biochemical validation (i.e., urine cotinine dipstick) indicative of low or no infant SHSe. Participants in the control group receive conventional education-based care. Assessments are completed at baseline, mid-point, and 1- and 4-months post-intervention. DISCUSSION: This study is the first to determine the efficacy of a brief intervention for reducing SHSe among high-risk, LBW infants discharged from a NICU, with the potential for saving lives and healthcare costs. Strengths, limitations and challenges to the conduct of this trial are discussed.

Treatment of cocaine-alcohol dependence with naltrexone and relapse prevention therapy.

This study evaluates whether patients with cocaine-alcohol dependence might benefit from naltrexone (NTX) pharmacotherapy when delivered in conjunction with psychotherapy. Eighty outpatients meeting DSM-IV criteria for alcohol and cocaine dependence were randomly assigned to receive NTX (placebo or 50 mg/d) combined with psychotherapy (Relapse Prevention [RP] or Drug Counseling [DC]) for twelve weeks. It was hypothesized that the skills training focus of RP therapy, in combination with NTX 50 mg/d, would produce greater reductions in cocaine and alcohol use. Outcome measures included self- and objective reports of substance use, treatment retention, medication compliance, and adverse effects. During the first four weeks of treatment, the percentage of cocaine-positive urine screens was significantly lower for those receiving RP therapy (22%) than those receiving DC (47%); however, this difference subsequently diminished. No medication effects were found. All groups reported less alcohol use at the end of treatment. Treatment retention was the same among the groups, with about 33% of the subjects completing all twelve weeks of treatment. The active medication group showed better medication compliance, while the number of adverse events was low overall and not significantly different by group. In conclusion, NTX at 50 mg/d did not reduce cocaine or alcohol use. These findings stand in contrast to previously reported positive findings for NTX and RP in patients with a single diagnosis of cocaine dependence.