David A Fiellin’s research while affiliated with Yale-New Haven Hospital and other places

Background Treatment of alcohol withdrawal syndrome (AWS) in hospitals is inconsistent. Electronic health record (EHR) order sets protocolize care. Objective We examined variation in AWS order sets across hospital organizations and their concordance with AWS guidelines. Methods We conducted a cross‐sectional study of hospital organization user‐created EHR order sets for AWS extracted from the December 2021 Epic® userweb community library. Hospital organizations with an acute care hospital and 1 AWS order set were included. We measured the proportion of guideline‐concordant care practices within four categories: (1) laboratory assessment, (2) risk assessment for severe AWS and associated management changes, (3) symptom assessment and treatment of AWS, and identification and management of complications and (4) screening, diagnosis, and treatment of unhealthy alcohol use and AUD including medications for alcohol use disorder (MAUD). Results Ninety‐five organizations with 289 order sets were included. The proportion of organizations with guideline‐concordant laboratory assessments included testing of electrolytes (83%), hepatic function (75%), substance use (83%), and screening for infections (33%). Guidance for assessing risk of severe AWS (34%) and indications for care escalation (63%) used inconsistent definitions. Use of guideline‐concordant medications for AWS (99%) and AWS symptom scores (91%) were nearly universal. MAUD was included by two organizations (2%). A common templated order set was used by 26% of organizations in EHR order sets. Conclusions We observed frequent organizational inclusion of guideline‐concordant medications and symptom scores but rare and/or poorly defined guidance for evaluating risk of severe AWS, escalation of care, and MAUD.

This cross-sectional study examines the availability of medications for opioid use disorder in psychiatric hospitals in the US.

Background Alternative models for methadone delivery outside of federal and state-regulated opioid treatment programs may improve access. We determined factors associated with clinician support for continuing office-based methadone. Methods We used data from the electronic Opioid Use Disorder Provider COVID-19 Survey conducted among X-waivered clinicians who were providing outpatient, longitudinal treatment of opioid use disorder (OUD) from July 2020 to August 2020. The outcome variable was selecting “The opportunity for patients to receive office-based methadone” when asked “Which pandemic-related policy changes or new policy changes would you like to be continued or started after the pandemic?” Using sequential multivariable logistic regression modeling, we estimated the association between clinician and practice characteristics and support for office-based methadone. Results Of 1900 respondents, 728 met the inclusion criteria. Twenty-eight percent indicated support for office-based methadone. Clinician characteristics associated with support for office-based methadone were being Black or African American versus White (adjusted odds ratio [AOR] [95% confidence interval (CI)], 2.88 [1.19–6.98]), having provided medications for OUD (MOUD) for >15 years versus ≤15 years (AOR [95% CI], 1.66 [1.02–2.68]), treating 51 to 100 patients with MOUD monthly versus <25 patients (AOR [95% CI], 1.79 [1.04–3.09]), providing methadone (AOR [95% CI], 1.71 [1.03–2.85]) versus not providing MOUD previously, and working in an academic medical center versus other settings (AOR [95% CI], 1.88 [1.11–3.16]). Conclusions A minority of surveyed X-waivered clinicians supported office-based methadone. Efforts to expand access to methadone via office-based settings should address implementation barriers.

Among persons with HIV (PWH), unhealthy alcohol use and polypharmacy contribute to bothersome symptoms (e.g., fatigue, dizziness, memory loss). However, effective risk communication targeting these associations is challenging. The HIV and Alcohol Research center focused on Polypharmacy (HARP) is conducting a pilot study that will generate feasibility and acceptability data on a clinical pharmacist-delivered counseling intervention targeting the modification of unhealthy alcohol use and polypharmacy in PWH. Counseling is guided by the Information-Motivation-Behavioral Skills-Motivational Interviewing (IMB-MI) model. Herein, we describe the study protocol. This pilot uses a one-group pre-test/post-test design. We will recruit 50 participants from those who participated in the consented cohort of the Veterans Aging Cohort Study. Participants must be prescribed ≥ 5 long-term medications, have a self-reported Alcohol Use Disorders Identification Test score > 0, and be living with HIV. We will exclude those with moderate-severe alcohol use disorder as identified by an Alcohol Symptom Checklist score ≥ 4. Data are collected using three self-administered surveys (baseline, immediately after booster intervention, and 30-days post-intervention), two PEth blood tests (baseline, 30 days post-intervention), and medication data from the electronic health record (baseline). The intervention includes a 60-minute IMB-MI-based counseling session followed by a booster session 2 weeks later. Some participants will also be asked to participate in a qualitative interview to provide feedback on the intervention. The pilot investigates the impact of an intervention on alcohol consumption and the use of multiple medications among PWH, exploring how best to reduce bothersome symptoms, communicate risk, and support behavior change in this population.

Background We examined the impact of integrated stepped alcohol treatment with contingency management (ISAT+CM) on alcohol abstinence among people with HIV (PWH) and unhealthy alcohol use. Methods In this multisite 24-week trial, we randomized PWH reporting untreated unhealthy alcohol use and with phosphatidylethanol (PEth) >20ng/mL to receive ISAT+CM or treatment as usual (TAU). Intervention : Step 1 : Social worker-delivered CM; Step 2 : Addiction physician management plus motivational enhancement therapy. Participants were advanced to step 2 at week 12 if they lacked evidence of abstinence over the prior 21 days. TAU : Health handout, and for those who met criteria for alcohol use disorder, a referral to substance use treatment. Primary outcome: self-reported abstinence over the past 21 days at week 24. Results We enrolled 120 PWH between January 5, 2018 and March 1, 2022. Mean age was 59 years, 96% were men, and 83% were Black. Eight percent were lost to follow-up. In the ISAT+CM group, 87% were advanced to Step 2. The posterior mean proportion of participants with self-reported abstinence at 24 weeks was higher among those randomized to ISAT+CM (posterior mean proportion 9% [95%CrI, 0%, 33%]) compared with TAU (posterior mean proportion 0.3 % [95%CrI, 0%, 4%]) (posterior mean treatment effect 9%, [95%CrI, 1%, 32%], the posterior probability of TAU being superior to ISAT+CM was <0.0001. Discussion ISAT+CM delivered in HIV clinics modestly increased self-reported 3-week abstinence among PWH. Our findings indicate a need for more effective treatments to promote abstinence and a potential role for ISAT+CM for reductions in alcohol use.

In this issue, Strain advocates for the field of addiction medicine to consider a new diagnostic signal—treatment-refractory addiction. Also in this issue, Nunes and McLellan support the concepts advanced by Strain. I provide an alternate view and propose that it is premature to create such a signal and that doing so could lead to unintended adverse consequences. My argument is based on 4 concerns: (1) the lack of neuroscientific correlates, (2) the profound impact that context has on what patients receive as “treatment,” (3) the rare provision of sequentially stepped treatment, and (4) the potential for misuse of the signal. Addiction medicine should be cautious in introducing concepts such as treatment-refractory addiction to ensure that patients are not seen as “treatment failures.” Our efforts should rather focus on the development of additional effective treatments, improving access to existing effective treatments and a creating a system that does not provide “failed treatments.”

Importance Buprenorphine is an effective yet underused treatment for opioid use disorder (OUD). Objective To evaluate the feasibility (acceptability, tolerability, and safety) of 7-day injectable extended-release buprenorphine in patients with minimal to mild opioid withdrawal. Design, Setting, and Participants This nonrandomized trial comprising 4 emergency departments in the Northeast, mid-Atlantic, and Pacific geographic areas of the US included adults aged 18 years or older with moderate to severe OUD and Clinical Opiate Withdrawal Scale (COWS) scores less than 8 (minimal to mild), in which scores range from 0 to 7, with higher scores indicating increasing withdrawal. Exclusion criteria included methadone-positive urine, pregnancy, overdose, or required admission. Outcomes were assessed at baseline, daily for 7 days by telephone surveys, and in person at 7 days. Patient recruitment occurred between July 13, 2020, and May 25, 2023. Intervention Injection of a 24-mg dose of a weekly extended-release formulation of buprenorphine (CAM2038) and referral for ongoing OUD care. Main Outcomes and Measures Primary feasibility outcomes included the number of patients who (1) experienced a 5-point or greater increase in the COWS score or (2) transitioned to moderate or greater withdrawal (COWS score ≥13) within 4 hours of extended-release buprenorphine or (3) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. Secondary outcomes included injection pain, satisfaction, craving, use of nonprescribed opioids, adverse events, and engagement in OUD treatment. Results A total of 100 adult patients were enrolled (mean [SD] age, 36.5 [8.7] years; 72% male). Among the patients, 10 (10.0% [95% CI, 4.9%-17.6%]) experienced a 5-point or greater increase in COWS and 7 (7.0% [95% CI, 2.9%-13.9%]) transitioned to moderate or greater withdrawal within 4 hours, and 2 (2.0% [95% CI, 0.2%-7.0%]) experienced precipitated withdrawal within 1 hour of extended-release buprenorphine. A total of 7 patients (7.0% [95% CI, 2.9%-13.9%]) experienced precipitated withdrawal within 4 hours of extended-release buprenorphine, which included 2 of 63 (3.2%) with a COWS score of 4 to 7 and 5 of 37 (13.5%) with a COWS score of 0 to 3. Site pain scores (based on a total pain score of 10, in which 0 indicated no pain and 10 was the worst possible pain) after injection were low immediately (median, 2.0; range, 0-10.0) and after 4 hours (median, 0; range, 0-10.0). On any given day among those who responded, between 29 (33%) and 31 (43%) patients reported no cravings and between 59 (78%) and 75 (85%) reported no use of opioids; 57 patients (60%) reported no days of opioid use. Improving privacy (62%) and not requiring daily medication (67%) were deemed extremely important. Seventy-three patients (73%) were engaged in OUD treatment on day 7. Five serious adverse events occurred that required hospitalization, of which 2 were associated with medication. Conclusions and Relevance This nonrandomized trial of the feasibility of a 7-day buprenorphine injectable in patients with minimal to mild opioid withdrawal (COWS scores, 0-7) found the formulation to be acceptable, well tolerated, and safe in those with COWS scores of 4 to 7. This new medication formulation could substantially increase the number of patients with OUD receiving buprenorphine. Trial Registration ClinicalTrials.gov Identifier: NCT04225598