Authors: Kathy T. LeSaint (Department of Emergency Medicine, University of California San Francisco, San Francisco, California, USA; California Poison Control System, San Francisco Division, San Francisco, California, USA), Emily E. Ager (Department of Emergency Medicine, University of California San Francisco, San Francisco, California, USA), Pranav Kaul (Department of Emergency Medicine, University of California San Francisco, San Francisco, California, USA), Curtis Geier (Department of Pharmacy Services, Zuckerberg San Francisco General Hospital & Trauma Center, San Francisco, California, USA), Craig G. Smollin (Department of Emergency Medicine, University of California San Francisco, San Francisco, California, USA; California Poison Control System, San Francisco Division, San Francisco, California, USA)
Categories: Research Letter
Source: Academic Emergency Medicine
Doi: 10.1111/acem.70341
Authors: Kathy T. LeSaint, Emily E. Ager, Pranav Kaul, Curtis Geier, Craig G. Smollin
The opioid withdrawal syndrome is characterized by a constellation of uncomfortable and at times intolerable physiological and psychological symptoms. Increased anxiety, irritability, restlessness, worsened pain, gastrointestinal distress, and decreased sleep are among the most common of these symptoms. The severity of these symptoms often prompts patients to seek care in the emergency department (ED) [1].
In recent years, the use of medications for treatment of opioid withdrawal and underlying opioid use disorder (e.g., buprenorphine and methadone) in the ED has become the standard of care. Buprenorphine, in particular, is preferred among ED clinicians due to its safety profile and ease of titration [2]. Buprenorphine titration allows for gradual, individualized dosing to manage cravings and alleviate opioid withdrawal symptoms while minimizing side effects before therapeutic stability is achieved. However, the induction and titration period can be uncomfortable for patients due to ongoing opioid withdrawal symptoms, which can be exacerbated if the timing and dose of buprenorphine is not sufficient. In addition, existing buprenorphine treatment guidelines are not standardized, so there can be significant titration variability among ED providers. Furthermore, the proliferation of fentanyl in the drug supply has made buprenorphine titration even more complicated, as fentanyl withdrawal is more severe and more enduring than heroin withdrawal and, in some cases, difficult to control despite newer recommendations of high‐dose buprenorphine titration [3].
In addition to the difficulties surrounding buprenorphine titration, there also exists intervention stigma around medications for opioid use disorder by patients that may lead to decreased adoption and a desire for alternative therapies to improve withdrawal symptoms [4]. Insufficient management of opioid withdrawal often leads to devastating results including treatment failure, return to use, and overdose. For these reasons, there is increasing interest in identifying non‐pharmacologic strategies to provide relief during the opioid withdrawal period. Identifying additional therapies to provide timely control of withdrawal symptoms is critical to avoid patient discomfort during an often‐vulnerable period.
Adjunctive therapies for managing opioid withdrawal focus on symptom alleviation and supporting opioid detoxification. The most frequently used adjunct therapies are non‐opioid pharmacologic adjunctive treatments, such as anti‐emetics or alpha‐2 adrenergic agonists. Additional non‐pharmacologic adjuncts in the treatment of opioid withdrawal have been previously studied, including exercise, yoga therapy, and neural stimulation [5, 6, 7]. In this pilot study, we explored the novel use of a weighted blanket as an adjunctive therapy to help mitigate the heightened anxiety of opioid withdrawal during sublingual buprenorphine administration and up‐titration in the ED. Prior studies suggest a weighted blanket is an effective non‐invasive form of deep pressure stimulation, which can result in a calming influence due to an increase in parasympathetic arousal and an appropriate therapeutic tool in reducing anxiety [8].
We performed a cross‐sectional study at the Zuckerberg San Francisco General Hospital & Trauma Center (ZSFG) ED during a 6‐month period from April 2024 to October 2024, and explored the novel use of a weighted blanket as an adjunctive therapy to help mitigate the symptoms of opioid withdrawal, such as heightened anxiety, pain, agitation, and irritation, during buprenorphine administration and uptitration. We enrolled a convenience sample of patients who were given their first dose of sublingual buprenorphine for treatment of opioid withdrawal in the ED during traditional business hours of the week (Monday through Friday, 8 AM–5 PM). Eligible participants were in moderate to severe opioid withdrawal and had received one dose of buprenorphine at the time of enrollment. The ZSFG ED sublingual buprenorphine initiation protocol includes recommendations to start the medication when a patient has a Clinical Opiate Withdrawal Scale (COWS) score of at least 8, though deviations from the protocol may occur upon clinician discretion and patient shared decision‐making.
All purchased weighted blankets were medical grade, reusable, weighed 15 pounds (6.8 kg), and cost $165 USD each. Our team purchased 10 weighted blankets to account for simultaneous patient usage. After each use, the reusable blankets were cleaned by our team's clinical research coordinator (CRC) using pre‐saturated durable, non‐woven, hospital‐grade disinfectant cleaning wipes routinely available in our hospital, which is in line with the disinfectant protocol outlined by the manufacturer on the product information page [9]. This weight of 15 pounds is approximately 10% of an average adult body weight and has been shown in prior studies to be most effective at producing a calming effect and at reducing pain [10, 11].
The enrollment process required referral of the patient to a CRC by the ED substance use navigator (SUN). The SUN, who works directly in the ED and is aware when buprenorphine is administered, sent an electronic message to the CRC when an appropriate patient was identified. The CRC then came to the ED, placed a weighted blanket on the patient, and notified the patient's clinical team. The patient then underwent usual clinical care. The primary outcome was the self‐reported reduction in opioid withdrawal symptoms. Once a patient was queued for disposition (admission or discharge), the CRC returned to the ED and asked patients to consent to a survey related to their experience using the weighted blanket. The survey was conducted via iPad (Supporting Information S1). Participants were provided a $5 gift card to Walgreen's Pharmacy upon survey completion.
We collected demographic data and patient perspectives regarding weighted blanket use. We also collected information regarding the patient's ED course, including chief complaint, initial COWS score, and buprenorphine administration. Descriptive statistics were used to summarize patient demographic, clinical, and survey data. All analyses were performed using Stata 18.5 (StataCorp, College Station, TX). This study was categorized as exempt by the UCSF Institutional Review Board (RB #23‐40037).
During the 6‐month study period, 10 patients were referred from the ED SUN to the CRC. Four patients were one patient was not enrolled due to consultation received outside CRC workhours, one patient had already received 3 doses of buprenorphine prior to referral, and two patients were discharged prior to CRC arrival in the ED. Analysis was performed on data obtained from six patients.
The demographic and clinical characteristics of the study population can be found in Table 1. The mean age was 40 years. Three patients presented with a chief complaint of “withdrawal,” one arrived with a chief complaint of “overdose,” one arrived with a chief complaint of “generalized body aches,” and one arrived with a chief complaint of “shortness of breath.” The mean initial COWS score was 8.8 (standard deviation 2.5).
Two patients received an initial sublingual buprenorphine dose of 8 mg while four patients received an initial dose of 16 mg. Two patients received a total sublingual buprenorphine dose of 16 mg, three patients received a total of 24 mg, and one patient received a total of 32 mg during their ED encounter.
On ED arrival, the mean heart rate was 82.2 beats per minute (bpm) (standard deviation (SD) 27.0 bpm), the mean systolic blood pressure was 133.2 mmHg (SD 18.5 mmHg), and the mean diastolic blood pressure was 83.3 mmHg (SD 9.0 mmHg). The mean vital signs on discharge were heart rate 69.2 bpm (SD 12.4 bpm), systolic blood pressure 124.0 mmHg (16.7 mmHg), and diastolic blood pressure 76.7 mmHg (10.9 mmHg).
The average time from buprenorphine administration to blanket administration was 47.6 min. As self‐reported from the patient satisfaction survey, three patients (50%) kept the weighted blanket in place for the entire duration of their stay. ED staff removed the blanket prematurely to conduct clinical care on the other three (50%): for two patients, the blanket was intermittently removed and for one patient, the blanket was permanently removed and was not on the patient when the patient was seen by the CRC. These three patients, however, kept the weighted blanket on during most of their ED encounter.
Five patients (83%) reported that the addition of the weighted blanket helped with their symptoms of opioid withdrawal. Participants self‐reported that the blanket helped to reduce anxiety (n = 1), reduce pain (n = 1), and reduce agitation and irritation (n = 2). In the free text field, participants reported the blanket “keeps the body calm,” “feels like a warm embrace,” “helped with relaxation and sleep,” “…helped with everything, with pain,” and “helped keep warm.” One patient who presented with an initial COWS score of 13 did not believe the weighted blanket helped with mitigating opioid withdrawal symptoms, though they reported that they felt like “nothing helped the withdrawal.” Despite this, all six patients responded “yes” when asked if they would want the weighted blanket as part of their treatment if they were to experience opioid withdrawal again.
Limitations of this pilot study include its cross‐sectional design and small study population. The study period was ended early due to funding restrictions. In addition, our protocol required a time‐constrained coordinated effort and required the collection of patient data during business hours only. This design significantly limited our patient enrollment and led to the small sample size. A weighted blanket intervention could otherwise be given to a patient by any clinical provider at any time of the day. Furthermore, our intervention lacked a control group or blinding, which makes it difficult to appreciate the effects of this intervention from natural history or placebo effect. Nevertheless, while small, this pilot study is hypothesis generating and demonstrates the feasibility of weighted blanket use for opioid withdrawal. Relative patient satisfaction with the intervention may warrant a larger prospective analysis.
In addition, our average time to blanket use was approximately 48 min, which aligns with the expected time of onset of buprenorphine's opioid agonist effects. Therefore, symptom improvement reported by participants may have been attributable to buprenorphine rather than the weighted blanket intervention, particularly as reductions in anxiety, agitation, and similar symptoms are expected buprenorphine effects.
Prior studies, particularly in the occupational therapy literature, have demonstrated the efficacy of a weighted blanket in reducing anxiety and agitation in various populations [8]. This pilot study found a high rate of satisfaction regarding the use of a weighted blanket as an adjunctive non‐pharmacologic treatment in the alleviation of opioid withdrawal symptoms during treatment with buprenorphine.
Dissatisfaction with the weighted blanket may have been related to the extent of opioid withdrawal (e.g., severe versus mild to moderate withdrawal); that is, patients with severe withdrawal may have less symptom improvement from a weighted blanket given their need for higher or more rapidly titrated doses of buprenorphine. Indeed, the one patient who reported that the addition of a weighted blanket did not help with symptoms of opioid withdrawal had an initial COWS score of 13. The findings also suggest an associated improvement in vital signs at discharge, although this finding could be attributed to buprenorphine and not the weighted blanket.
Future research should evaluate weighted blanket use in a randomized control trial. Patients initiating buprenorphine in the ED could be randomized to weighted blanket plus usual care versus usual care alone, or to an active control such as a standard hospital blanket to account for warmth and attention effects. Because of the overlap between blanket placement and expected onset of buprenorphine effect, future trials should also standardize timing of blanket application relative to medication administration and include serial Clinical Opiate Withdrawal Scale (COWS) scores to better isolate the intervention's independent effect. Stratification by baseline withdrawal severity may also be warranted, as patients with more severe withdrawal may respond differently to this intervention. Assuming a moderate effect size based on existing psychiatry research, approximately 80–90 participants per arm would be required to adequately power a two‐arm trial [11].
Based on these preliminary data, health systems may strongly consider the use of this relatively low‐cost, non‐harmful intervention to mitigate symptoms of opioid withdrawal among ED patients. This intervention may help lead to beneficial outcomes for patients with opioid use disorder, including increased comfort during buprenorphine initiation and titration in the ED.
Study concept and Kathy T. LeSaint, Craig G. Smollin. Acquisition, analysis, or interpretation of Emily E. Ager, Curtis Geier, Pranav Kaul, Kathy T. LeSaint, Craig G. Smollin. Drafting of the Emily E. Ager, Curtis Geier, Pranav Kaul, Kathy T. LeSaint, Craig G. Smollin. Critical revision of the Kathy T. LeSaint, Craig G. Smollin. Statistical Emily E. Ager. Acquisition of Kathy T. LeSaint, Craig G. Smollin.
This study was funded, in part, by the University of California San Francisco/Zuckerberg San Francisco General Hospital & Trauma Center Clinical Practice Group Strategic Use of Reserves Fund 5.0 grant. The sponsor had no role in the preparation, review, or approval of this manuscript, nor the decision to submit the manuscript for publication. The contents of the article are solely the responsibility of the authors and do not necessarily represent the official views of the sponsors. Drs. Ager and Kaul were supported by the National Clinician Scholars Program at the University of California San Francisco during this study.
No large language models (e.g., Rytr or ChatGPT) was used to develop any portion of our methodology nor write any part of this submission.