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13 Articles in Volume 12, Issue #9
PROMPT Challenges PROP’s Petition
PROP Answers Questions Raised About Opioid Label Changes
PROP vs PROMPT: Who Speaks for the Pain Doctor?
PROP’s Petition: PPM’s Editorial Board Weighs in
Assessment of Long-term Outcomes Of Opioid Treatment: How to Set Goals and Objectives
Extracorporeal Shock Wave Therapy: Applications in Pain Medicine—Part One
Neck Pain: Diagnosis And Management
Part Two: Trigeminal Neuralgia: A Closer Look at This Enigmatic and Debilitating Disease
Reducing Musculoskeletal Disorders Through Ergonomics
Risk Evaluation and Mitigation Strategy Compliance
Treating the Opioid-addicted Chronic Pain Patient: The Role of Suboxone
Electromagnetic Devices: A New Partner in Pain Management
Methadone Management in a Patient With Pain and History Of Addiction

Treating the Opioid-addicted Chronic Pain Patient: The Role of Suboxone

Difficult cases often test the skill of pain practitioners.

Chronic pain and addiction are frequent comorbidities, creating a therapeutic dilemma for many pain specialists. A recent small-scale trial indicated that approximately one-third of chronic pain patients may have an addictive disorder.1 In addition the non-medical use of opioids is an ever-escalating concern, with reports that about 5% of the population are abusing opioids, including 11.4% of youths aged 12 to 25 years.2 Patients with opioid addiction report chronic pain quite commonly and may present with chronic pain symptoms due to sympathetic arousal, sleep disorders, increased risk for trauma, increased tolerance, and increased stress with hippocampus-pituitary-adrenal axis activation.3

A patient with chronic pain and addiction is also at increased risk for overdose.4,5 The reasons for this are complex and include an increased tolerance to opioids, opioid craving related to addiction, the use of opioids to self-medicate concomitant psychological symptoms, and the impact of withdrawal from all addictive substances on worsening chronic pain syndromes.

Risk Stratification: Identifying High-risk Patients
It is recommended that all pain patients be screened for psychological comorbidities before prescribing medical therapy. Screening for addiction risk, however, can be difficult as the hallmark of the disease is denial of the consequences of addiction on an individual’s life.6 I recommend two screening tests that require minimal training and fewer than 2 minutes to administer in the office. They are the CAGE (adapted to include drugs) and the Drug Abuse Screening Test (DAST).7,8 In addition, the Webster and Webster Opioid Risk Tool (ORT) and the Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R) are two easy-to-use tools that can help identify risk of opioid medication misuse (Table 1).9,10 Appropriate screening with history, physical examination, and urine drug testing can help make a determination ahead of time regarding what the relative risk (risk stratification) of most patients is to develop an opioid-related adverse event if opioids are prescribed. Read More on the Addiction Patient in a 2019 Literature Review Series.

Defining AddictionTable 1. Tools for Determining Risk of Aberrant Behavior

Pain Patients Already on Opioids
Unfortunately, many physicians find themselves in a situation where they are seeing chronic pain patients already on opioid therapy with addiction problems. We now understand that these patients are not only at highest risk for overdose and diversion, but they are the least likely to improve function while on an opioid, especially if the opioid is the primary form of pain treatment.11,12

While identifying patients with addiction problems and referring them for appropriate addiction treatment is ideal, this is frequently a diagnosis that may require a number of visits and difficult decisions concerning suitable chronic pain treatment. However, it is important to set a structure in your practice that minimizes risks for all patients. As noted, it is important to take a careful medical history, including substance abuse history, as well as perform a medical evaluation (Table 2).13

 

Table 2. Medical History and Evaluation For Suspected Substance Abuse

Table 3. Pharmacokinetics of Suboxone And its Metabolite, Norbuprenorphine

Currently, there are no high-quality studies regarding the percent of patients treated with opioid pain medications who developed de novo opioid addiction or dependence. One of the questions most frequently asked is concerning the role of Suboxone (buprenorphine/naloxone) in this setting.14 Patients requesting Suboxone therapy for opioid addiction or dependence may be using opioids without a prescription, prescription opioids alone, or both. For patients on prescription opioids, problems with addiction may have predated their use of prescription medications or began only after starting therapy with prescription opioids. While asking about a previous history of addiction and alcohol problems is important, it may be difficult to determine the extent of the patient’s previous problems with opioids prior to their difficulties with prescription medications. This is frequently addressed during addiction treatment as relapse prevention strategies are reviewed and underscore the importance of concomitant addiction treatment during Suboxone therapy.

Suboxone for Addiction
Suboxone was first approved in 2002 for the treatment of opioid addiction, but not chronic pain. Prior to its approval, opioid addiction was most commonly treated with methadone. Methadone can be dispensed only in a limited number of clinics that specialize in addiction treatment. According to the FDA, “There are not enough addiction treatment centers to help all patients seeking treatment—therefore, Suboxone was the first opioid available under the Drug Abuse Treatment Act of 2000 for the treatment of [opioid] dependence that can be prescribed in a doctor’s office.”

Suboxone contains buprenorphine and naloxone. Buprenorphine is an opioid partial agonist with high affinity for the µ and κ receptors that is effective at preventing opioid withdrawal and cravings while the patient participates in addiction treatment. Naloxone, an opioid antagonist, was added to guard against misuse. Suboxone is currently available as a sublingual film. The half-life of buprenorphine is 24 to 60 hours, making daily or every other daily dosing possible when used for treatment of opioid addiction (Table 3).15 Table 4 lists possible drug–drug interactions with Suboxone.15

Suboxone was specially formulated to help curb abuse. For example, there is a ceiling effect of Suboxone and taking >16 to 32 mg per day will not result in any further positive drug effects and in fact may precipitate withdrawal. If injected, Suboxone produces severe withdrawal symptoms, but no adverse effects when taken orally as prescribed. In addition, taking other opioids while on Suboxone may also precipitate withdrawal. This gives the medication less risk of abuse and side effects than full opioid agonists.

However, the risks of side effects of Suboxone dramatically increase when it is used with alcohol, benzodiazepines, and illicit drugs.13 This makes Suboxone therapy for patients with polysubstance abuse an increased challenge, as it is important to continue to monitor and address any aberrant drug-taking behavior. As noted, patients on benzodiazepine therapy will have increased risk of adverse outcomes if Suboxone is used. For this reason, patients with opioid addiction as part of a polysubstance abuse diagnosis and those on benzodiazepines may not be appropriate candidates for Suboxone or may need a residential or in-patient evaluation before a decision is made about whether to use Suboxone. At the very least, intensive outpatient therapy and careful monitoring will be very important to ensure safety and management of withdrawal symptoms (Table 5).

Table 4. Drug-Drug Interatctions With SuboxoneTable 5. Tips for Prescribing Suboxone

Suboxone Induction
Once a decision is made to use Suboxone as part of a treatment program for opioid addiction the patient is started on the agent through an induction process. Most patients will stop their opioids a few hours to one day prior to Suboxone induction. Decisions about Suboxone dosing are then made related to the patient’s withdrawal symptoms. Some patients on very high doses of opioids (>250 mg of morphine equivalent) may benefit from tapering their opioid dose below a dose of 250 mg of morphine equivalent prior to stopping their current opioid medication entirely at the time of induction. Another option for patients on very high doses of opioids is to look at a more supervised setting for Suboxone induction, such as a residential or in-patient environment.

As noted, during the induction process the patient is observed for symptoms of withdrawal to determine the proper dosing of Suboxone. Most providers will start with a 2 to 4 mg dose of Suboxone and use the Clinical Opiate Withdrawal Scale assessment for opioid withdrawal to make further determinations (COWS Sidebar).16 This process will usually last 2 to 3 days and can be done in an outpatient setting for most patients, with a typical stabilization dose of 12 to 16 mg daily. Patients who have been on higher doses of opioids, especially for a prolonged period of time, may require a higher dose of Suboxone for initial stabilization—but this dose should never exceed 32 mg daily. This dose can then be tapered once the patient is further stabilized and involved in addiction treatment.

Analgesic Effect
Buprenorphine has powerful analgesic activity. It is important to reiterate that Suboxone is approved in the United States for treatment of opioid addiction and not for chronic pain. A lower-dose transdermal formulation of buprenorphine (Butrans) is available for the management of moderate to severe chronic pain. These patches are available in three doses (5 mcg, 10 mcg, and 20 mcg) and are applied once weekly in patients with chronic pain. The dose of buprenorphine in Suboxone is higher than in the transdermal patch and is not approved for use in opioid-naïve patients or patients without opioid dependence. The usual dosage range of Suboxone for maintenance therapy is between 8 and 16 mg daily. However, the dosage range will need to be individualized, with some patients doing well on lower doses and others requiring a higher maintenance dose to start.

As an opioid, buprenorphine will have an analgesic impact on patients with chronic pain. The analgesic half-life of buprenorphine is 6 to 8 hours. When buprenorphine is used for treatment of both addiction and chronic pain the dosing may need to be split to be dosed two or three times per day. It is important to review with the patient that Suboxone is being used to treat opioid addiction and the split dosing may provide some help with their pain as an added benefit, but the medication dosing is not to be changed during periods of increasing pain.

Management of Acute Pain
One of the trickiest challenges for patients on Suboxone therapy for opioid addiction is the management of acute pain. Because prescribing a full µ agonist opioid may precipitate opioid withdrawal in patients taking Suboxone, the challenges of pain management in the setting of acute pain is one of the things a provider will need to discuss with a patient ahead of time.

For the patient who has a non-emergent problem with anticipated acute pain, such as elective surgery or dental work that is expected to result in significant pain to warrant opioid therapy, it is best to discontinue Suboxone 24 to 48 hours prior to the anticipated procedure.17 If the patient experiences pain during this period prior to the procedure, an opioid or other pain medication can be used. After the procedure, the patient is allowed to receive pain medication, keeping in mind that opioid medication will be needed to prevent withdrawal as well as to treat pain. The dose of opioid will need to be carefully titrated according to the patient’s symptoms. This is because opioid-dependent patients may need a higher dose of opioids to control acute pain than other patients. Suboxone can then be restarted once the need for an opioid for acute pain management has passed.

For unanticipated acute pain that requires opioid analgesia, the patient will need to stop Suboxone immediately until the need for opioid analgesia is over.18 Options for acute pain management can include regional analgesia and/or the use of a full µ agonist opioid for pain control. A high-potency opioid such as fentanyl that can be carefully titrated may provide the best option, but other opioids can be used as well. Cautions during this period of time include the following potential problems:

  • Until the effect of Suboxone has worn off the addition of a full µ agonist can precipitate some withdrawal symptoms
  • Suboxone may initially block the effect of the opioid used for pain. This impact will change as the level of buprenorphine in the system decreases, creating a changing need for opioid dosing that must be carefully monitored
  • The impact of Suboxone on acute opioid therapy will need to be reviewed with the patient and all providers caring for the patient. Once the need for opioid analgesia has passed Suboxone can be restarted.

Treatment of Chronic Pain
We are discovering that in any patient, the sole use of opioids for treatment of chronic pain is fraught with risks when it is not associated with a more complete biopsychosocial approach to pain management, as well as careful patient monitoring. Ideally, non-opioid therapies (both pharmacologic and non-pharmacologic) should be prescribed to address the issues of ongoing pain problems. It is frequently difficult to separate some of the symptoms a patient is having related to their pain from symptoms related to opioid addiction or dependence. Both medical problems will increase pain, interfere with sleep, have an impact on mood, and impact day-to-day functioning. How long a patient remains on Suboxone is individualized, and it may be used just for a few weeks in some individuals and a number of years in others. When a decision is made to lower the dose of Suboxone or discontinue the medication entirely, it will need to be tapered. For chronic pain patients, the key issue when their opioid is decreased is their pain level, and that should drive the rate of tapering.

Other Treatment Options
There are many non-opioid pharmacologic agents that have been shown to be effective for chronic pain. These can include topical agents, non-steroidal anti-inflammatory drugs, acetaminophen, anticonvulsants, and antidepressants. Keep in mind that muscle relaxants have limited usefulness chronically and carisoprodol (Soma) has significant abuse potential. Chronic benzodiazepine use should be avoided in all patients with chronic pain, especially those with addictive disorders.

In addition, many non-pharmacologic treatment options have been shown to be important for treatment of pain including cognitive behavioral therapy, yoga, relaxation techniques, mindfulness training, physical therapy, interventional options, appropriate orthopedic evaluation and interventions, and chiropractic care. Improvement in function and realistic goal setting are critical for successful pain treatment and are an important part of pain care for all patients (Treatment Algorithm).

Special Training Required
Suboxone can be prescribed in a primary care setting as long as there is a mechanism for addiction treatment in place in addition to use of the medication. In order to prescribe Suboxone a separate certificate is needed in addition to a Drug Enforcement Agency certificate. Providers eligible for this certificate are physicians who hold an addiction psychiatry subspecialty board certification from the American Board of Medical Specialties, hold an addiction medicine certification from the American Society of Addiction Medicine (ASAM), or who hold an addiction medicine subspecialty board certification from the American Osteopathic Association (AOA). Completion of an authorized training program on the treatment or management of opioid-dependent patients will also enable providers to apply for a certificate to use Suboxone. Organizations currently authorized to provide training for a Subxone certificate are the American Academy of Addiction Psychiatry, American Medical Association, AOA (through the American Osteopathic Academy of Addiction Medicine), American Psychiatric Association, and ASAM. Information about these courses can be found on their Web sites.

It is important to couple Suboxone therapy with an active addiction recovery program, such as Narcotics Anonymous (NA, which is similar to the 12-step Alcohol Anonymous programs) geared towards improvement in function. When treating patients with chronic pain this is doubly important, as many of the aspects of an addiction recovery program are part of pain treatment as well. Addiction treatment and pain treatment both focus on:

  1. Education—Pain and addiction triggers, the role of diet, the role of exercise, the role of pacing activities, safe medication use, and education about the role of the body’s own pain relievers (endorphins, norepinephrine, dopamine, and serotonin)
  2. Spiritual reconnection—Meditation, support groups (group therapy and NA meetings), meaningful rituals (for example, family, religious, or community activities that reinforce positive contributions and communication with other people)
  3. Mind—Sleep, hygiene, relaxation, fear and stress reduction, distraction, repattern thinking, and attitude
  4. Social interactions—Improved family interaction, communication, problem solving, improved functioning at work or volunteering

For more information on addiction education, go to www.nida.nih.gov.

Clinical Opiate Withdrawal Scale (COWS)Clinical Opiate Withdrawal Scale (COWS)

Addressing Other Addictions
While the focus of this discussion has been related to issues surrounding opioid addiction and pain, it is important to remember that patients with addictions to other substances need addiction treatment in order to make progress in terms of treating their chronic pain. Many substances that will need to be addressed are obvious and without controversy, such as cocaine, amphetamines, or excessive drinking. Other substances such as cannabinoids—while known to have significant addiction potential and drug interactions with opioids and other potentially cognitively impairing medications—have become more controversial as states have developed medical marijuana laws. However, having a legal status does not take away from risks and these will need to be addressed when taking care of patients with chronic pain.

One legal substance that has been shown to greatly increase risks of pain and substance-use relapse is nicotine. Patients addicted to nicotine have higher rates of opioid misuse and dependence than patients who do not use nicotine.19 In addition, the literature reports that daily smokers have a higher incidence of pain than non-smokers. Men who smoke have a higher incidence of lumbar discectomy for chronic pain.20 Smoking alters the pharmacokinetics of opioids resulting in lower serum levels and less efficacy despite a higher average daily dose. It is very important to address concerns regarding nicotine dependence in all patients being seen for chronic pain and to recognize its role in increasing opioid dependence and abuse.

Treatment algorithm for Suboxone evaluation in a patient with opioid addiction/dependence and chronic pain

Conclusion
Treating patients with pain and addiction are common problems facing providers and these patients can appear to be some of the most challenging patients seen in any clinical setting. It is important to remember that addiction treatment is as successful as treating other chronic illnesses, with some studies showing that for every $1 invested in addiction treatment programs there is a return of between $4 and $7 in reduced drug-related crime, criminal justice costs, and theft alone. When savings related to health care are included, total savings can exceed costs by a ratio of 12 to 1.14 It is important for all providers to understand the resources available to treat addiction in their community and to also understand that chronic pain with comorbid addiction is unlikely to be effectively treated with an opioid prescription alone.

Last updated on: March 1, 2019
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