Hello, and welcome to the fifth module of the CDC series Applying CDC's Guideline for Prescribing Opioids. In this module, we'll look at how opioid use disorder (OUD) is diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, or DSM-5, assessment criteria, and how to discuss this diagnosis with your patients. You will have the opportunity to examine the different types of medications used for medication-assisted treatment (MAT) for opioid use disorder and how to taper opioids when opioid harms exceed benefits but OUD DSM-5 criteria are not met. Throughout this module, you will be presented with multiple choice knowledge checks to test your mastery of the content.
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CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016
You may find it useful to refer to the CDC Guideline during this module. You can access, download, and print a copy of this and other helpful documents by selecting the Resources tab at any time. Some screens include a link icon which, when selected, opens additional online resources. Let's take a closer look at the navigation features of this web-based training. As you've experienced already, the Next and Back buttons enable you to move to a new screen or back to a previous screen. If either the Next or Back button is dimmed, it is disabled, and you will need to complete an action onscreen to continue. Refer to the navigation prompt located at the bottom of the screen to help you determine how to proceed. Selecting the Menu button in the upper right corner opens a list of all the topics available in the module. A selection made from the list advances the training to that topic. Pressing the open Menu tab a second time will collapse it. There is also a set of audio controls located at the bottom of the training window. Here you can pause or play the narration, control the volume, and open the text transcript for the narration if needed. Most slides, however, will not be narrated, and this set of controls will be dimmed and disabled.
This training was developed in accordance with research, guidance, educational materials, and other resources available from the Substance Abuse and Mental Health Services Administration (SAMHSA) on the topic of opioid use disorder.
About 2.1 million Americans had opioid use disorder in 2016.
The last two diagnostic criteria, related to tolerance and withdrawal, are not considered to be met for individuals taking opioids solely under appropriate medical supervision.
Tolerance is defined as either: 1) a need for markedly increased amounts of opioids to achieve intoxication or desired effect, or 2) a markedly diminished effect with continued use of the same amount of an opioid.
You can refer specifically to DSM-5 Criteria A and B for opioid withdrawal syndrome:
Diagnosing OUD requires a thorough evaluation, which may include obtaining the results of urine drug testing and prescription drug monitoring program (PDMP) reports, when OUD is suspected.
It is also important to remember that OUD exists on a continuum of severity. As a result, a scale for assigning severity exists and is based upon the number of criteria that have been met (mild, moderate, severe). This severity distinction has treatment implications.
DOB: 4/11/1984
Medical history: Lower back pain: Began after a fall at work 3 years ago; Lifting heavy objects at work exacerbated the injury; Currently takes extended-release morphine 45 mg twice daily to treat pain
PDMP data does not show any additional controlled substance prescriptions other than the extended-release morphine prescription described above.
[Doctor] Hi John, it's nice to meet you. I see you recently moved to the area and you are looking to establish care. Can you tell me what is going on?
[Patient] Well, I had a fall at work a few years ago and I've been taking pain meds for it, but they've run out. Since I ran out I've had some really bad nausea and diarrhea, and I feel really achy. I've run out of my pain meds before and I felt the same way. I have tried to cut down on the amount of pills I take so that I can get to my next refill, but I need more pills to make these symptoms go away.
[Doctor] Okay, can you tell me more?
[Patient] I am currently taking 45 milligrams of extended-release morphine twice a day, but it doesn't seem to be working and feel I need a bigger dose. In fact, I've had to skip work several times because my symptoms get so bad after running out of my medicine.
[Doctor] Have you tried any methods for pain relief that didn't involve opioids?
[Patient] My prior doctor recommended I try working some regular exercise into my day and even try things like yoga and acupuncture, but that's just not for me so I haven't done it. Ibuprofen just didn't cut it either.
Based on the information shared so far, is it correct to suspect John meets the criteria for OUD? Select the correct answer.
Based on the information John shared, OUD should be suspected, because he has met two or more of the DSM-5 criteria within a year:
In this scenario not all of the OUD criteria were assessed. Further discussion at this appointment and during future visits should assess whether he meets additional criteria suggesting moderate (4-5 criteria) or severe (6 or more criteria) OUD.
DOB: 1/28/1955
Medical history: Neck pain began following a motor vehicle crash 6 months ago; Takes extended-release oxycodone 20 mg twice daily
Generalized anxiety disorder: No co-occurring depressive symptoms; Has taken alprazolam 1 mg up to three times daily for many years
Other History: Has smoked a half-pack of cigarettes daily for 20 years; no history of illicit drug use or alcohol use
New data obtained today: PDMP does not reveal additional controlled substance prescriptions other than the opioid and benzodiazepine prescriptions described above
Urine drug test results from 1 week ago note the presence of oxycodone and benzodiazepines but no other controlled substances.
[Doctor] Hi Gail, I see that you are a new patient in our clinic since your primary care physician retired. Can you tell me what is going on?
[Patient] Thanks for seeing me. Well, I have had neck pain following a whiplash injury I got from a car accident about six months ago.
[Doctor] Okay, can you tell me more?
[Patient] I have been taking pain pills since my accident but I think I need more because I have been having some painful flare-ups.
[Doctor] Okay Gail, in looking at your chart, your primary care physician prescribed you 20 milligrams of extended-release oxycodone twice a day. Gail, I am going to ask you a few questions about the pain you are experiencing. On a scale of 1-10, with 10 being the worst pain, what number best describes your pain on average in the past week?
[Patient] I would say an 8, doc.
[Doctor] Now, what number best describes how, during the past week, pain has interfered with your enjoyment of life?
[Patient] I would say about 8 for enjoyment of life.
[Doctor] Also, what number best describes how, during the past week, pain has interfered with your general activity?
[Patient] I would say 9 for general activity.
Based on the information shared so far, is it correct to suspect Gail meets the criteria for OUD? Select the correct answer.
Based on the information gathered, Gail does not meet the DSM-5 criteria for OUD.
In order to rule out OUD definitively, however, further discussion now or during future visits would need to assess whether or not she meets criteria.
Her complaints of increased pain merit further exploration. Also, her continued concurrent use of opioids with benzodiazepines is risky.
If you suspect OUD, you should not dismiss patients from care. Instead, use the opportunity to provide potentially lifesaving information and interventions.
You should discuss your concern with your patient and provide an opportunity for him/her to disclose any related concerns or problems.
You can use the DSM-5 criteria to assess for the presence of OUD or arrange for assessment with a substance use disorder specialist.
You can perform urine drug testing (UDT) to obtain information about drug use that is not reported by the patient. For more information on UDT, refer to the Reducing the Risks of Opioids module.
You should also review data from your state's prescription drug monitoring program (PDMP) for opioids or other controlled medications that patients might have received from other providers.
Let's take a moment to review how you can talk to a patient if he or she meets the DSM-5 criteria for OUD. Use statements such as:
"Trouble controlling the use of opioid medication makes it unsafe, and long-term risk over time is substantial."
"The medicine has become a problem in itself. You have developed a known complication of therapy that we should not ignore."
"Continuing the current medication is not a reasonable option due to the risks, but there are options for treating what we call opioid use disorder, also known as OUD."
"It seems as if you are running out of your medication more quickly than anticipated."
"Sometimes people become too comfortable with the medications and start to take them for reasons other than pain."
"You meet the criteria for opioid use disorder, also known as OUD. It's helpful to put a name on it because it opens up a variety of approaches to help with your specific circumstance."
Now, let's review some specific strategies you can use to help patients understand their diagnosis of OUD.
Use statements such as:
Relationship-building skills include reflective listening and empathetic statements to destigmatize OUD diagnosis and treatment. Use statements such as:
Use statements such as:
[Doctor] Okay John, in reviewing your history, you have been taking prescription opioids for a few years now after your work accident to manage your pain but haven't been able to return to work.
[Patient] That's right doc.
[Doctor] Also, it looks like you have been having some difficulty controlling your medication use and you've skipped work a few times because your symptoms got worse.
[Patient] Yes, and I still feel I am not taking enough and need more.
How would you discuss with your patient that he meets the criteria for a diagnosis of OUD? Select the best response.
Answer choice A is correct. When talking with patients who meet the criteria for OUD, it's important to approach them with compassion, use relationship-building skills such as reflective listening and empathetic statements, and explain the treatment methods.
For persons diagnosed with OUD, first determine the severity of the substance use disorder. Identify any underlying or co-occurring diseases or conditions, the effect of opioid use on your patient's physical and psychological functioning, the outcomes of past treatment episodes, and the patient's potential for overdose. Risk factors for overdose include a past history of overdose, a history of substance use disorder, high opioid dosages (>50 MME/day), and concurrent benzodiazepine use.
Consider offering a prescription of naloxone when one or more of these risk factors are present, and educate the patient and his or her family about the symptoms of opioid overdose and how to administer naloxone. For more information about naloxone, visit https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.
Then, identify any underlying or co-occurring diseases or conditions, the effect of opioid use on your patient's physical and psychological functioning, and the outcomes of past treatment episodes.
An assessment should include:
A physical examination and laboratory testing should be conducted to ascertain conditions and symptoms related to addiction and its complications.
Indicators can include:
Perform laboratory testing based on clinical circumstances:
1. Review "Interagency Guideline on Prescribing Opioids for Pain, Appendix D: Urine Drug Testing for Monitoring Opioid Therapy" for more information on interpreting urine drug testing results.
Medication-assisted treatment (MAT) is considered the best treatment option for OUD as part of a comprehensive treatment plan.
MAT for OUD is defined as the use of one of three medications (buprenorphine, naltrexone, or methadone) in combination with psychosocial and/or behavioral therapy, through one of the following:
Multiple factors may influence the selection of a specific type of MAT.
Buprenorphine is likely to be safer than methadone for overdose risk, given its activity as a partial opioid agonist and lower potential for respiratory depression. Unlike methadone, the lack of required daily visits to a treatment center can also be an advantage. Another advantage of buprenorphine is the availability of long-acting injectable or implantable formulations that carry a low risk of diversion and can be managed as a monthly visit.
Methadone therapy for OUD requires frequent opioid treatment program visits (daily in early treatment) and may be inconvenient or feel stigmatizing for some patients.
Naltrexone is available in both an oral formulation, taken daily, and an extended-release intramuscular injection formulation, administered once monthly. An advantage of naltrexone therapy is that there are no special regulatory requirements involved; any licensed clinician with the ability to prescribe medication can prescribe naltrexone. Also, naltrexone has no abuse potential. However, despite these advantages, oral naltrexone is less frequently used to treat opioid use disorder (OUD); also, currently there is no clear evidence that predicts which patients are best treated with extended-release naltrexone versus other available medications to treat OUD. Some experts recommend naltrexone primarily for highly motivated patients with a mild opioid use disorder and for patients whose occupations do not allow treatment with opioid agonists (methadone) or partial agonists (buprenorphine).
There are a few additional considerations concerning opioid withdrawal when initiating MAT.
As naltrexone is an opioid antagonist and will immediately precipitate withdrawal if taken while opioids remain in one's system, patients must remain abstinent from short-acting opioids (e.g. hydrocodone) for 7 to 10 days or from long-acting opioids (e.g. methadone, buprenorphine) for 10 to 14 days before receiving naltrexone.
Buprenorphine patients do not need to have all opioids out of their system but should be in mild to moderate opioid withdrawal when starting.
When the patient is in mild to moderate withdrawal, buprenorphine's effects on the opioid receptors as a partial agonist are experienced as relief from withdrawal symptoms.
However, if buprenorphine is started in a patient on full agonist opioids who is not in withdrawal, buprenorphine will displace the full agonist from opioid receptors, precipitating withdrawal symptoms.
Patients for whom methadone therapy is being considered do not need to have all opioids out of their system, similar to buprenorphine, and should be in mild to moderate withdrawal. Because of the considerable variability among patients in methadone's bioavailability, clearance, and half-life, dosing should "start low and go slow." Patients starting methadone should be monitored very closely and be informed that the full effect of the initial dose might not be felt for 4 or more days, due to methadone's long half-life (24-36 hours) and time required to reach steady-state levels.
There are many other strategies that can benefit your patient alongside MAT initiation.
It's important to educate your patient about the way the medication to treat OUD works, associated risks and benefits, rationale for informed consent, and overdose prevention.
There is a potential for relapse and overdose upon discontinuation of the medication. Patients should be educated about the effects of using opioids and other drugs while taking the MAT medication and the potential for overdose if opioid use is resumed after tolerance is lost.
Loss of tolerance occurs when someone stops taking an opioid after long-term use. When someone loses tolerance and then takes the opioid drug again, they can experience serious adverse effects, including overdose and death, even if they take an amount that caused them no problem in the past.
Sources:
It's important to have an integrated treatment approach to meet the substance use, medical and mental health, and social needs of your patient. Reach out to existing mental health service providers or refer patients when necessary.
All medications for the treatment of OUD should be prescribed as part of a comprehensive individualized treatment plan that includes counseling and other psychosocial therapies, as well as social support through peer support specialists, formal support groups, and other mutual-help programs.
Refer your patient for more intensive or specialized services if office-based treatment with buprenorphine or naltrexone is not effective or you do not have the resources to meet a particular patient's needs. You can find programs in your area or throughout the United States by using SAMHSA's Behavioral Health Treatment Services Locator at findtreatment.samhsa.gov.
If using buprenorphine for OUD, here is information on the administration frequency/routes, who may prescribe or dispense, pharmacological category, clinical uses, and contraindications/warnings.
Oral buprenorphine is taken daily (also with alternative dosing regimens) and is taken through buccal film or oral tablet that is dissolved under the tongue. Long-acting buprenorphine is either injected under the skin monthly or is implanted under the skin every six months.
The FDA has approved the following buprenorphine formulations for treatment of opioid use disorder. Buprenorphine is also used to treat pain and is marketed for pain treatment under different brand names than those listed here:
Product Name |
Form |
Active Incredients |
|---|---|---|
| Bunavail® | Buccal film | Buprenorphine/naloxone |
| Suboxone® | Sublingual tablet and buccal film | Buprenorphine/naloxone |
| Subutex® | Sublingual tablet | Buprenorphine |
| Zubsolv® | Sublingual tablet | Buprenorphine/naloxone |
| Buprenorphine HCl | Sublingual tablet | Buprenorphine |
| Probuphine® | Implant | Buprenorphine |
| SublocadeTM | Long-acting Injection | Buprenorphine |
Note that the morphine milligram equivalent (MME) thresholds presented in the Guideline refer to dosing opioids for pain and do NOT apply to opioid agonists (methadone) or partial agonists (buprenorphine) when used for opioid use disorder.
To prescribe or dispense buprenorphine, providers must have board certification in addiction medicine or addiction psychiatry and/or complete special training to qualify for the federal waiver to prescribe buprenorphine, but any pharmacy can fill prescriptions for oral formulations. Injectable and implantable buprenorphine is only handled by specialty pharmacies. There are no special requirements for staff members who dispense buprenorphine under the supervision of a waivered physician.
Buprenorphine is considered an opioid partial agonist. The partial agonist effect relieves withdrawal symptoms resulting from cessation of opioids. This same property will induce a syndrome of acute withdrawal in the presence of long-acting opioids or sufficient amounts of receptor-bound full agonists.
Naloxone, an opioid antagonist, is sometimes added to buprenorphine to make the product less likely to be abused by injection. The naloxone component will have no effect when taken in tablet form. However, if it is injected, the naloxone will precipitate withdrawal.
Ideal candidates are patients who are motivated to adhere to the treatment plan and who have no contraindications to buprenorphine therapy. Buprenorphine should be part of a comprehensive management program that includes psychosocial support. Buprenorphine may be used in women with OUD who are pregnant or breastfeeding and have consulted with their doctors.
Buprenorphine should not be given to patients who are hypersensitive to buprenorphine or naloxone.
Caution is required in prescribing buprenorphine to patients with polysubstance use and those who have severe hepatic impairment, compromised respiratory function, or head injury. Significant respiratory depression and death have occurred in association with buprenorphine, particularly when administered intravenously or in combination with benzodiazepines or other central nervous system depressants (including alcohol).
As previously noted buprenorphine may precipitate withdrawal if initiated before patient is in opioid withdrawal, particularly in patients being transferred from methadone. Therefore, buprenorphine should be started at least 6-12 hours after the last dose of heroin or immediate-release opioids and longer after extended-release opioids, at least 36 hours after the last dose of methadone.
If using methadone for OUD, here is information on the administration frequency/routes, who may prescribe or dispense, pharmacological category, clinical uses, and contraindications/warnings.
Methadone is given once daily and administered orally in liquid concentrate, tablet, or wafer forms.
Methadone may only be prescribed or dispensed through SAMHSA-certified Opioid Treatment Programs for daily administration either on site or, for stable patients, at home.
Methadone is considered an opioid agonist. Patients starting methadone should be educated about the risk of overdose during induction, if relapse occurs, or if substances such as benzodiazepines or alcohol are consumed.
During induction, a dose that seems initially inadequate can be toxic a few days later because of accumulation in body tissues.
Methadone is used for the detoxification and maintenance treatment of opioid use disorder. Withdrawal after regular opioid use does not need to be completed before initiating methadone.
Ideal candidates are patients who have no contraindications to methadone therapy and are motivated to adhere to the treatment plan, which includes daily in-person clinic visits.
Also, methadone should be part of a comprehensive management program that includes psychosocial support.
Methadone may be used in women with OUD who are pregnant and have consulted with their doctors and may be used with precautions while breastfeeding.
Methadone should not be given to patients who are hypersensitive to methadone hydrochloride or any other ingredient in methadone hydrochloride tablets, diskettes, powder or liquid concentrate. It should also not be given to patients with respiratory depression (in the absence of resuscitative equipment or in unmonitored settings) and in patients with acute bronchial asthma or hypercarbia. In addition, it should not be given to any patient who has or is suspected of having a paralytic ileus
Methadone should be used with caution in elderly and debilitated patients; patients with head injury or increased intracranial pressure; patients who are known to be sensitive to central nervous system depressants, such as those with cardiovascular, pulmonary, renal, or hepatic disease; and patients with comorbid conditions or concomitant medications that may predispose to dysrhythmia or reduced ventilatory drive, including benzodiazepines or other central nervous system depressants (including alcohol). It should also be administered with caution to patients already at risk for development of prolonged QT interval or serious arrhythmia.
If using naltrexone for OUD, here is information on the administration frequency/routes, who may prescribe or dispense, pharmacological category, clinical uses, and contraindications/warnings.
Oral naltrexone is taken daily (also with alternative dosing regimens) by mouth. Extended-release naltrexone is administered monthly through an intramuscular (IM) injection into the gluteal muscle by a physician or other health care professional.
Naltrexone may be prescribed or dispensed by any individual licensed to prescribe medicines (e.g., physician, physician assistant, nurse practitioner).
Naltrexone is considered an opioid antagonist. It displaces opioids from receptors to which they have bound. This can precipitate severe, acute withdrawal symptoms if administered in persons who have not completely cleared opioid from their system.
Patients who have been treated with naltrexone will have reduced tolerance to opioids. Therefore, subsequent exposure to previously tolerated or smaller amounts of opioids may result in overdose.
The oral form of naltrexone has been found to have limited effectiveness, given the need for daily administration, its relatively short half-life, and the requirement for opioid abstinence prior to initiation. Adherence can be improved with directly observed administration. After weighing risks and benefits, as well as consideration of alternative treatment options, oral naltrexone can be considered in limited circumstances, such as for patients who cannot afford the extended-release form of naltrexone; patients with high levels of monitoring and negative consequences for nonadherence, such as health professionals who may not be permitted to take opioid agonist treatment; and patients leaving controlled environments such as prisons or inpatient addiction rehabilitation, who may derive benefit from treatment to prevent return to opioid use but are unable to receive the extended-release form nor opioid agonist therapy.
The extended-release injectable formulation of naltrexone is FDA-approved for the prevention of return to opioid dependence following medically supervised withdrawal. It has been found to be more effective than either placebo or no medication in reducing the risk of return to opioid use. Unlike oral naltrexone, which is dosed daily, the extended-release formulation is administered monthly. Appropriate candidates for treatment with extended-release naltrexone include patients who have been abstinent from opioids for at least 1 week and also:
Naltrexone should not be given to patients receiving long-term opioid therapy. It should also not be given to patients who are engaged in current opioid use (as indicated by self-report or a positive urine drug screen) or who are on buprenorphine or methadone maintenance therapy, as well as in those currently undergoing opioid withdrawal.
In addition, it should not be given to patients with a history of sensitivity to polylactide-co-glycolide, carboxymethylcellulose, or any components of the diluent; patients whose body mass precludes IM injection with the 2-inch needle provided (inadvertent subcutaneous injection may cause a severe injection site reaction); pregnant patients; and to anyone allergic to naltrexone.
Which medication used in MAT for OUD must be prescribed through an opioid treatment program? Select the correct answer.
Methadone may only be prescribed or dispensed through SAMHSA-certified Opioid Treatment Programs for daily administration either on site or, for stable patients, at home.
Naltrexone may be prescribed or dispensed by any individual licensed to prescribe medicines. However, buprenorphine can only be prescribed or dispensed by providers who complete special training to qualify for a federal DEA waiver.
In addition to the resources provided in this module, you can assess your community's treatment capacity for OUD.
Identify the specific treatment resources for OUD in your community. You can view opioid treatment programs by state through SAMSHA's Opioid Treatment Program Directory, via the following link: http://dpt2.samhsa.gov/treatment/directory.aspx
You can also access SAMSHA's Behavioral Health Treatment Services Locator, via the following link: https://findtreatment.samhsa.gov/
Work with other primary care providers to ensure sufficient treatment capacity at the practice level.
Consider training for and obtaining a DEA waiver that allows you to prescribe buprenorphine to treat patients with OUD.
If you are not currently trained and in possession of a waiver, refer your patients to a substance use disorder specialist.
Also, become familiar with naltrexone as an OUD treatment option that does not require any additional training. For more information, select the following link: https://www.samhsa.gov/medication-assisted-treatment/treatment/naltrexone
Providers prescribing opioids should identify treatment resources for opioid use disorder in the community and should work together to ensure sufficient treatment capacity for opioid use disorder at the practice level. Providers should assess for the presence of opioid use disorder using DSM-5 criteria. If providers suspect opioid use disorder, they should discuss their concern with their patient and provide an opportunity for the patient to disclose related concerns or problems. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder. Providers should assist patients in finding qualified treatment providers and should arrange for patients to follow up with these providers, as well as arranging for ongoing coordination of care. Providers should not dismiss patients from their practice because of a substance use disorder because this can adversely affect patient safety and could represent patient abandonment.
Providers should identify treatment resources for OUD in the community
Providers should assess for the presence of OUD using DSM-5 criteria
Providers suspecting OUD should discuss their concern with their patients
Providers should offer or arrange evidence-based treatment for patients with OUD
Providers should assist patients with follow-up and ongoing coordination of care
Providers should not dismiss patients from their practice because of a substance use disorder
You may now continue to the Training and Continuing Education Online System (TCEOnline) to receive continuing education credit for this training module.
Please register on TCEOnline, search for the course (WB2863), select the appropriate credit type, and complete the course evaluation and posttest in the Participant Services section.
Select Information for Providers at the URL below for clinical tools and other resources designed to help you apply these recommendations in your practice.
