By Ellen Feldman, MD
Altru Health System, Grand Forks, ND
SUMMARY POINTS
- Mindfulness-oriented recovery enhancement (MORE) is a unique group therapy that integrates elements of several types of therapies to target reward center dysfunction, which is felt to be critical in addressing chronic pain and opioid misuse.
- In all, 250 individuals diagnosed with chronic pain and opioid misuse were randomized to receive either MORE or a control supportive group therapy. They were followed for nine months to determine response to each intervention.
- At nine months, 45% of the participants receiving MORE had stopped misusing opioids, compared to 19% of those in the active control group receiving generic supportive group therapy (P = 0.01).
- Compared to those in the control group, participants in the MORE group also showed significant reduction in pain severity, pain-related interference in function, opioid use and reported lower levels of emotional distress and opioid craving.
SYNOPSIS: A randomized, controlled trial involving 250 primary care patients diagnosed with comorbid chronic pain and opioid misuse found that a specially designed, mindfulness-based group therapy showed superiority to generic supportive group therapy in reducing opioid use and controlling symptoms of chronic pain.
SOURCE: Garland EL, Hanley AW, Nakamura Y, et al. Mindfulness-oriented recovery enhancement vs. supportive group therapy for co-occurring opioid misuse and chronic pain in primary care: A randomized clinical trial. JAMA Intern Med 2022;182:407-417.
Aldous Huxley wrote in Brave New World, “And if ever, by some unlucky chance, anything unpleasant should somehow happen, why, there’s always soma to give you a holiday from the facts. And there’s always soma to calm your anger, to reconcile you to your enemies, to make you patient and long-suffering. In the past you could only accomplish these things by making a great effort and after years of hard moral training. Now, you swallow two or three half-gramme tablets, and there you are.” Huxley could not have predicted today’s opioid crisis, but his dystopian novel warned of the addiction potential of such agents.1
While opioids were unregulated and widely used in medicine prior to 1900, the passage of the 1914 Harrison Narcotic Control Act (spurred on by heroin’s street availability) led to years of limited use of narcotics in medicine.2 However, by the end of the 1980s, medical professionals started to take notice of the “undertreatment” of pain. In response, the American Pain Society and Veteran’s Health Administration launched campaigns to include pain as the fifth vital sign. The Joint Commission then published standards for pain management, and the Drug Enforcement Agency lessened standards of oversight for those who prescribe narcotic medications. This increased access to pain medication resulted in an increase in addiction, an increase in prescription opioid overdose deaths, diversion of these agents (out of the medical community), and an increased demand for street equivalent drugs, such as heroin.2,3
During this same time (the late 1900s through the early 2000s), pharmaceutical companies joined providers in managing patient pain. New extended-release opioid formulations (such as oxycontin, released in 1995) were introduced and promoted as having less addiction potential. It did not take long, however, to uncover the addiction and overdose risks related to these new agents. By 2017, Health and Human Services declared the opioid crisis a public health emergency, and new guidelines for management of pain rather than amelioration of pain were introduced.3,4
There is an inherent difficulty in treating primary care patients with chronic pain who are prescribed opioids but have misused these medications. While treatment guidelines from organizations such as the Centers for Disease Control and Prevention recommend implementing nonpharmaceutical interventions, there are limited evidence-based studies regarding the efficacy of such treatments for opioid misuse for this population.5
Recognizing the need for such studies, Garland et al designed a randomized clinical trial to evaluate the clinical advantages of a specially designed mindfulness-based group therapy compared to supportive group therapy in reducing opioid misuse and improving pain-related interference in function. Mindfulness is a technique dating back to at least the 1800s, when the term emerged as an adaptation of a Buddhist concept considered to be on the pathway to enlightenment.
About 100 years later, the idea was secularized by molecular biologist and meditator Jon Kabat-Zinn, who defined mindfulness as, “The awareness that arises through paying attention on purpose in the present moment, and non-judgmentally.” Mindfulness techniques have grown in popularity as standalone or adjunct interventions for a range of disorders, including opioid misuse disorder and chronic pain.6
Mindfulness-oriented recovery enhancement (MORE) is designed to target the dysregulation of the reward center that is so prominent in patients with comorbid chronic pain and opioid disuse. The theory is that prolonged opioid use increases neurobiological vulnerability to pain and emotional distress while decreasing perception of pleasure derived from natural stimuli.
Through a combination of mindfulness techniques and principles derived from cognitive behavioral therapy (CBT) and positive psychology, MORE has shown evidence of efficacy in treating opioid overuse and/or chronic pain in short-term pilot studies.7 Garland et al designed this current study to include long-term follow-up of nine months and to treat patients with comorbid chronic pain and opioid misuse in a primary care setting.
Subjects were recruited from January 2016 until January 2020 from six primary care clinics in Salt Lake City, UT. Eligibility included a chronic pain diagnosis, opioid prescription for more than three months, and an opioid misuse diagnosis as measured on the Current Opioid Misuse Measure (COMM) — a validated scale measuring opioid misuse or disorder.8
MORE and the active control psychotherapy groups were delivered in primary care clinics in groups of six to 12 participants for two hours across eight weeks. One unique feature of MORE was the inclusion of techniques to not only decrease the effect of negative emotions, but also to increase and amplify awareness of positive emotions and events. Both MORE and the supportive psychotherapy interventions included a homework component. For the MORE group, this consisted of audio-guided mindfulness practice with daily electronic logging and use of mindfulness prior to taking any opioid medication to help the participant bring to conscious awareness the reason for taking the medication (craving vs. pain relief, for example).
Outcomes were measured periodically for nine months following recruitment. The Drug Misuse Index, using a compilation of data from three sources (the self-reported COMM, clinician interviews, and urine toxicology screens) was employed to measure opioid misuse.9 The level of chronic pain was measured using two subscales from the Brief Pain Inventory.10 Other validated scales were used to assess emotional distress and the level of opioid craving.
RESULTS
Of the 250 patients enrolled in the study, just over 60% were women, and 87.2% self-identified as white. At baseline, most of this group was prescribed oxycodone or hydrocodone, with a small percentage (10.8%) on methadone or buprenorphine. Compliance was high, with 81.2% (203 participants) completing at least five of the eight groups, but participation fell off significantly during the COVID-19 pandemic, which coincided with the last year of the study.
At nine months of follow-up, the odds ratio (OR) for reduced misuse of opioids in the MORE arm vs. the supportive psychotherapy arm was 2.06 (95% confidence interval [CI], 1.17-3.61; P = 0.01). Specifically, at nine moths, 36 of 80 participants (45%) in the MORE group no longer were misusing opioids, compared to 19 of 78 participants (24.4%) in the control group. Table 1 displays other results from the study at baseline and the nine month follow-up mark.
Table 1. Comparison of Opioid Misuse Treatments |
||||||
| MORE Group at Baseline | Supportive Psychotherapy Group at Baseline | MORE Group at Nine Months | Supportive Psychotherapy Group at Nine Months | OR at Nine Months | P Value | |
Severity of chronic pain measured via Brief Pain Inventory (range 0-10) |
Mean: 5.65 |
Mean: 5.24 |
Mean: 4.86 |
Mean: 5.51 |
0.49 (95% CI, 0.17-0.81) |
0.003 |
Decreased functional interference from chronic pain measured via Brief Pain Inventory (range 0-10) |
Mean: 6.47 |
Mean: 6.14 |
Mean: 4.91 |
Mean: 6.30 |
1.07 (95% CI, 0.64-1.50) |
< 0.001 |
Decreased emotional distress (Depression Anxiety Stress Scale) |
Mean: 21.45 on standard scale |
Mean: 22.77 on standard scale |
Mean: 18.78 on standard scale |
Mean: 20.77 on standard scale |
3.05 (95% CI, 0.63-5.07) |
0.01 |
Morphine equivalent dose of opioid |
Median: 35 mg |
Median: 38 mg |
Median: 23 mg |
Median: 38 mg |
0.15 (95% CI, 0.03-0.27) |
0.009 |
MORE: mindfulness-oriented recovery enhancement; OR: odds ratio; CI: confidence interval |
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COMMENTARY
This randomized trial comparing two nonpharmacologic interventions for treatment of chronic pain in patients with concurrent opioid misuse brings valuable information to a field in need of evidence-based treatment. Long-term opioid treatment for chronic pain is not uncommon in primary care settings; however, there are very few published studies investigating behavioral interventions for this population. With current studies estimating that 25% of patients prescribed long-term opioids will misuse these agents, the need for validated treatment options for these individuals is increasingly urgent.11
Interestingly, opioid misuse decreased in participants in both the MORE group and those in the active control group (supportive psychotherapy.) However, the MORE intervention was associated with significantly greater increase in reduction of opioid misuse as well greater decreases in pain severity, functional impairment from pain, and emotional distress. These findings have potential clinical relevance especially because the interventions were designed to be delivered in a primary care clinic. Notably, one of the few other studies of behavioral interventions for opioid misuse and chronic pain used CBT, which is a component of MORE. However, this study found that, while CBT seemed to reduce the level of pain, there was no associated reduction in opioid use or misuse.12 This finding may point to the efficacy of MORE residing in the combination of techniques that result in a restructuring of the reward processing center. Future studies looking specifically at the components of MORE may shed further light on the mechanism of action. This investigation entered the last year of recruitment and follow-up in early 2020. Given the onset of the pandemic in March 2020, it is not surprising that participation fell at that point. Garland et al noted that the withdrawal rates were similar in both arms of the study. It is important to replicate and broaden studies like this one among individuals of various races, cultures, and socioeconomic backgrounds to be able to confidentially generalize results.
The type of pain and other specific characteristics of a patient also may be relevant in the potential to respond to MORE or other similar therapies; future studies in the field may uncover these nuances. Overall, it will be equally important to advocate for broad access to professionals trained to deliver therapeutic interventions such as MORE because regional accessibility of psychotherapists is quite variable. However, with the information we currently have, the primary care clinician is on firm ground looking toward behavioral and mindfulness interventions in the treatment of chronic pain and opioid misuse. The choice of intervention may be limited by local or regional availability, but knowing that the type of intervention most likely has clinical relevance may assist with choice.
REFERENCES
- Lohnes K. Brave New World. Britannica. Updated Nov. 9, 2022. https://www.britannica.com/topic/Brave-New-World
- Jones MR, Viswanath O, Peck J, et al. A brief history of the opioid epidemic and strategies for pain medicine. Pain Ther 2018;7:13-21.
- Georgetown Behavioral Health Institute. The origin and causes of the opioid epidemic. Published Aug. 14, 2018. https://www.georgetownbehavioral.com/blog/origin-and-causes-of-opioid-epidemic
- U.S. Department of Health and Human Services. What is the U.S. opioid epidemic? Last reviewed Oct. 27, 2021. https://www.hhs.gov/opioids/about-the-epidemic/index.html
- Centers for Disease Control and Prevention. Opioids: Healthcare professionals. Last reviewed Aug. 6, 2021. https://www.cdc.gov/opioids/healthcare-professionals/index.html
- Shapiro S, Weisbaum E. History of mindfulness and psychology. Psychology. Published Feb. 28, 2020. https://doi.org/10.1093/acrefore/9780190236557.013.678
- Parisi A, Roberts RL, Hanley AW, Garland EL. Mindfulness-oriented recovery enhancement for addictive behavior, psychiatric distress, and chronic pain: A multilevel meta-analysis of randomized controlled trials. Mindfulness (N Y) 2022;13:2396-2412.
- Butler SF, Budman SH, Fanciullo GJ, Jamison RN. Cross validation of the current opioid misuse measure to monitor chronic pain patients on opioid therapy. Clin J Pain 2010;26:770-776.
- Ducharme J, Moore S. Opioid use disorder assessment tools and drug screening. Mo Med 2019;116:318-324.
- Stanhope J. Brief Pain Inventory review. Occup Med (Lond) 2016;66:496-497.
- Chou R, Fanciullo GJ, Fine PG. Opioids for chronic noncancer pain: prediction and identification of aberrant drug-related behaviors; A review of the evidence for an American pain society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:131-146.
- de C Williams AC, Fisher E, Morley S. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev 2020;8:CD007407.
A randomized, controlled trial involving 250 primary care patients diagnosed with comorbid chronic pain and opioid misuse found that a specially designed, mindfulness-based group therapy showed superiority to generic supportive group therapy in reducing opioid use and controlling symptoms of chronic pain.
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