Opioid policy debates are often framed in terms of balancing opioid risks with chronic pain relief. This assumes, not only that opioids provide long-term pain relief, but that opioids are necessary for pain relief. Based on our many years’ experience with successful opioid dose reduction in our structured multidisciplinary pain rehabilitation program, we suspected that this was not the case. These programs however, are expensive and not available to many of the patients interested in opioid taper. Hence, in order to explore a less expensive alternative we conducted a pilot study to determine if an outpatient opioid taper support intervention administered by a supervised physician assistant could promote opioid taper without increasing pain intensity or activity interference.
What did we do? We randomly assigned 35 patients receiving long-term opioid therapy for chronic pain to a 22-week taper support intervention or to usual care. The intervention consisted of: psychiatric consultation, opioid dose tapering, and 18 weekly meetings with a physician assistant to explore motivation for tapering and learn pain self-management skills. Usual care was usual specialty and primary care with no restrictions other than no use of buprenorphine. Our taper support intervention began with a visit to an experienced pain medicine/psychiatry physician (principal investigator), to evaluate whether adjustment or initiation of non-opioid psychotropic [e.g., antidepressant] medication was indicated based on psychiatric assessment. Patients next met with the study physician assistant for a Motivational Interviewing-based session exploring motivations for opioid tapering. Patients were also shown a short video of interviews with the patients who had tapered off opioids about the benefits and challenges of tapering off opioids. Among the 18 patients randomized to taper support, medication changes were recommended for 12.
Over the next 17 weeks, patients met with the physician assistant for weekly 30-minute sessions of pain self-management training, which was based on cognitive-behavioral therapy (CBT) interventions for chronic pain. At each visit, patients were provided with an opioid medication prescription for the week. The study protocol specified a 10% reduction of the original dose per week. However, patients could opt to pause the taper and hold their opioid dose steady at any point. We believe this option was crucial to our ability to retain patients in the taper support intervention.
What did we find? We used the adjusted mean daily morphine-equivalent opioid dose (MED) in the past week as the primary outcome. At 22 weeks, MED was lower in the taper support group, but this difference was not statistically significant (adjusted mean difference = -43 mg; p= 0.09) due to our small sample size. Pain severity ratings (0-10 NRS) decreased in both groups at 22 weeks, with no significant difference between groups (adjusted mean difference = -0.68 points; p = 0.30). The taper support group improved significantly more than usual care on the secondary outcomes of impact of pain on daily activities (pain interference), confidence In ability to carry out activities while in pain (self-efficacy), and prescription opioid problems (i.e.feeling sluggish or depressed due to opioids)” at 22 weeks (all p-values < 0.05). [ClinicalTrials.gov Identifier: NCT01883882]
What do the findings mean? Although this pilot study was small and some important outcomes were not significantly different between randomized groups, our study does show that this taper support intervention is feasible and shows promise in reducing opioid dose while not increasing pain severity or interference.
What were some of the limitations and barriers? We did have problems recruiting and enrolling patients into our trial. Among 144 patients referred to the trial, only one in four enrolled, taking us three years to recruit the 35 patients included in the study. Among patients on long-term opioid therapy, there is widespread ambivalence about this therapy. Many patients lament side effects, incomplete pain relief, and concerns about controlling their opioid use. But they are also afraid of uncontrolled pain that may result from opioid cessation. Many of them have tried to stop their opioids (often abruptly, “cold turkey”). This often resulted in increased pain and a resumption of opioid therapy. Hence, many patients who said they were interested in our trial and were referred to be enrolled could not bring themselves to begin opioid taper right now. In any future trial of an opioid taper support intervention, we believe that an enhanced engagement strategy to build trust and establish alignment with patient goals will be necessary.
What to do next? Based on our experience with this trial and decades of clinical experience, we believe that engagement with patients concerning their own life goals—beyond pain reduction—is crucial. While we had a favorable effect on pain with our intervention, many patients resist opioid taper due to fear of increased pain. Reviewing goals beyond pain reduction, helps patients clarify what is being gained and what is being lost for them through long-term opioid therapy. For many patients, long-term opioid therapy is NOT helping them meet these goals, but they are afraid to taper their opioids. While limited, our study provides indication that if we provide pharmacological and psychological support and skills for pain-self-management, patients may reduce opioid dose without pain increase and less pain interference. This preliminary indication warrants confirmation in a larger study.
The strategy of patient empowerment used in this trial of opioid taper support is one example of the general approach to patient participation in chronic illness care that I advocate in my new book, The Patient As Agent of Health and Health Care (Oxford, 2017; markdsullivan.org). In chronic illness, the patient is the agent through which health care is delivered and by which health is achieved.
About Mark D Sullivan
Dr. Sullivan received his M.D. and his Ph.D. in Philosophy from Vanderbilt University. He is Professor of Psychiatry and Adjunct Professor of Anesthesiology and Pain Medicine and Adjunct Professor of Bioethics and Humanities at the University of Washington. He has served as attending physician in the UW Center for Pain Relief for over 25 years, where he is Co-Director of Behavioral Health Services. He has published over 250 peer-reviewed articles, many on the interaction of physical health and mental health in patients with chronic illness.
Mark D. Sullivan, Judith A. Turner, Cory DiLodovico, Angela D’Appollonio, Kari Stephens, Ya-Fen Chan (2017) Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain 18(3): 308-18.