Skip to main content

Guidance for Primary Care and Pediatric Providers

The increasing rate of opioid use disorder (OUD) diagnoses, coupled with the shortage of treatment options for adolescents, strongly support the provision of medication for addiction treatment (MAT) by adolescent providers. Pediatricians, family physicians, and other physicians who care for young adults are well positioned to offer treatment and services. The following sections serve as a manual for providers in the prescribing of MAT for adolescents and young adults.

Screening

Screening, Brief Intervention, and Referral to Treatment (SBIRT)

The American Academy of Pediatrics supports the use of SBIRT in adolescent primary care. Information about screening in primary care can be found at: https://www.mcpap.com/
pdf/S2BI%20Toolkit.pdf or https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-resources/screening-tools-for-adolescent-substance-use. 

Adolescents and young adults who engage in high-risk behaviors may also be screened for sexually transmitted infections and blood-borne infections such as gonorrhea, chlamydia, syphilis, HIV, as well as hepatitis A, B, and C viruses. Positive test results can be addressed with referral to experienced providers and integrated into overall care management planning for youth. Youth not immune to hepatitis A and B should be offered vaccinations.

Pre-Exposure Prophylaxis (PrEP)

In May 2018, the Food and Drug Administration approved daily oral antiretroviral pre-exposure prophylaxis (PrEP) with Truvada (emtricitabine/tenofovir disoproxil fumarate) for adolescents under 18 who weigh at least 77 lbs. and are at heightened risk of acquiring HIV infection based on established criteria. Laws and regulations concerning consent, confidentiality, and parental disclosure differ by jurisdiction. Additional information about adolescent PrEP use will be incorporated in upcoming CDC guidelines. This will be available at: https://www.cdc.gov/hiv/guidelines/index.html. 

Special Considerations for MAT in Adolescents and Young Adults Aged 16-25 years

DATA 2000 and CARA 2016

In 2000, US Congress passed the Drug Addiction Treatment Act, known as DATA 2000, which allows physician to apply for a waiver to prescribe buprenorphine in general medical settings, after an eight hour training course. Several organizations, including the American Academy of Pediatrics, have endorsed an adolescent-specific training course for pediatric providers (https://www.aap.org/mat). Once waivered, these physicians can prescribe buprenorphine.

In 2016, the Comprehensive Addiction and Recovery Act (CARA) was signed into law, which extended this waiver to NPs and PAs who have completed 24 hours of training. 

Confidentiality and Consent in Youth Aged 16-17

Protecting confidentiality is critical in OUD treatment and management to support youth engagement in care. There are several specific laws that govern this subject. Of note, confidentiality laws do not preclude caregiver involvement. In general, engagement of caregivers as part of a young person's treatment plan leads to a higher level of success.

Caregiver Involvement

In general, programs should involve parents or other caregivers, henceforth parents, and other support systems whenever possible. Parental consent and involvement optimize success and retention in treatment. In many cases, these support systems may already be aware of their child's opioid use, and the young person may give permission to discuss treatment and progress with parents. If a patient is 18 or older and wants clinicians to communicate with his or her parents, medical releases of information should be signed with a clear delineation of what information can be shared (e.g. treatment attendance, diagnostic impression, recommendations for treatment, clinical course in treatment, results of toxicology testing). 

Code of Federal Regulations, 42 CFR Part 2

Federal laws and regulations specific to substance use treatment apply, beyond the usual confidentiality regulations with the Health Insurance Portability and Accountability Act (HIPAA). Specifically, the US Code of Federal Regulations (CFR) restricts disclosure of alcohol and drug treatments records, even for purposes of other medical treatment, or healthcare operations without written consent of the patient. This applies to all records relating to identity, diagnosis, prognosis, or treatment of any patient in a substance use program. These restrictions apply to any federally assisted programs, as well as any providers prescribing MAT under a federal DEA license.

Treatment Protocol

A basic overview and guide is provided within this toolkit. The protocols below have been adapted from guidance from the Providers Clinical Support System (https://pcssnow.org/) and Carney, et al.

Program Development

Practices should establish a clinical model that includes a medical provider who prescribes medication and can monitor treatment, as well as a mental health practitioner who can provide adjunctive behavioral therapy. 

Medication Induction and Treatment

Prior to starting medication treatment, patients should be assessed for severity of OUD using the criteria set forth in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Clinicians should also assess for other substance use and SUD, including alcohol, marijuana, benzodiazepines, and tobacco, and discuss all treatment options available to the patient. Additionally, practitioners should asses for any co-occurring mental health disorders that should be addressed concurrently in treatment.

Practices that provide MAT should have specific treatment agreements and consent forms that are reviewed with a clinician and signed by patients and parents or legal guardians (for patients under 18 who have parental consent for treatment). A sample treatment agreement is included in Appendix 6.3 of this toolkit. Treatment agreements outline expectations of the patient and clinician visit adherence, expectations around medications and prescriptions, participation in toxicology testing, and participation in behavioral health counseling. There are several modalities of behavioral health counseling that are age-appropriate for adolescents and are described in further detail in Section 3 of this toolkit.

This is also an appropriate time to have patients and families sign medical release forms to allow clinicians to communicate with other care providers and trusted adults working with an adolescent, including prior and current clinicians, outside behavioral health providers, school officials, and other trusted adults who may not be legal guardians of the patient but are involved in care planning.

Counseling families and caregivers about medication safety is important at initial and subsequent visits. This includes: storing medications in a lockbox; observed medication administrations (particularly for adolescents under 18); safety measures to prevent unintentional ingestion by younger children or other members of the household; and overdose prevention and education (including provision of naloxone for overdose reversal). Notably, the risk of overdose from buprenorphine when taken as directed (while ensuring that young people do not simultaneously use alcohol, benzodiazepines, or other sedatives) is extremely low. However, younger children, particularly those under the age of six years, remain at risk of overdose on buprenorphine at doses
prescribed to treat opioid use disorders in adolescents.

Laboratory Tests and Medical Clearance

Once a clinician and patient decide to begin MAT, practitioners should conduct baseline laboratory testing, including liver function tests, and screening for human immunodeficiency virus (HIV), syphilis, gonorrhea/chlamydia, and viral hepatitis. Patients should be up to date on vaccinations, with particular attention to the hepatitis A and B vaccine series.

Biologically female patients should undergo a urine pregnancy test, as pregnancy may change treatment considerations and planning for the patient and clinician (Section “2 Pregnancy” for more information).

Toxicology Testing

Practices differ in their approach to frequency of toxicology testing (most commonly urine or saliva). In general, frequency of testing should be based on the individual needs of patients. Fundamentally, the purpose of such tests is to monitor adherence to treatment and provide an opportunity to address other drug use. As noted in the prior section, careful attention should be paid to the concurrent use of benzodiazepines, as this can greatly increase the risk of overdose in a patient on an opioid agonist (i.e., buprenorphine or methadone). Drug panels differ in what drugs they test for and how to interpret results. Therefore, it is crucial for physicians to be aware of what tests their practice utilizes. Common urine drug panels include monitoring of opiates, cocaine, amphetamines, benzodiazepines, and barbiturates. Often an additional order is necessary to test for synthetic opioids such as oxycodone, methadone, buprenorphine, and fentanyl. Whether clinics test for tetrahydrocannabinol (THC), the active compound in marijuana, differs from site to site. Clinicians should be mindful that false negatives and positives can occur with toxicology testing and should contact the laboratory that tested the sample with any questions.

For clinicians considering the implementation and schedule of urine drug testing, The American Academy of Pediatrics’ recommendations and Levy and Siqueira (2014) can be valuable
resources.

Types of MAT

The basics of buprenorphine and naltrexone are covered below, followed by recommendations
for course of treatment.

Buprenorphine

Buprenorphine is a partial agonist of the mu opioid receptor. Approval of the use of buprenorphine for adolescents 16 years and older was granted in 2003. Buprenorphine is commonly prescribed as a daily medication via sublingual tablets or films. New formulations, such as a monthly injection, and an implant form have also been approved for use in adults.  As of publication of this toolkit, the weekly injection is not yet approved by the FDA. Future research into the newer injection and implant formulations still needs to be conducted for adolescents and young adults. Buprenorphine can be prescribed weekly once a patient is stabilized, providing more flexibility in the spacing of clinic visits based on patient response. 

Of the three medications, buprenorphine is the best studied among adolescents and young adults. The extant body of literature suggests that adolescents who remain on buprenorphine for longer periods experience reduced risk of relapse and longer retention in addiction treatment, although the optimal duration of treatment is not known. One randomized controlled trial demonstrated that adolescents aged 13 to 18 years old who received buprenorphine treatment were more likely to be retained in treatment, have negative urine tests for opiates, and transition to naltrexone, compared to those who received only clonidine for opioid withdrawal symptoms. Further research indicates that
longer course of treatment for adolescents on buprenorphine leads to lower rates of illicit opioid use. Clinical trial data also suggest that remaining on buprenorphine (rather than discontinuing the medication after withdrawal symptoms are addressed) results in improved clinical outcomes. Continued buprenorphine adherence over one year is associated with an increase in treatment retention and longer-term abstinence. In practice, many adolescents and families request to discontinue buprenorphine once in stable recovery; however, there are not data to support whether or when this is the best approach.

Buprenorphine Training

In accordance with DATA and CARA legislation, buprenorphine requires special training for prescription. Waivered providers can prescribe buprenorphine in any pediatric practice. Once completed, providers can increase the number of patients on buprenorphine in a stepwise fashion in the following way: During the first year after prescription waiver, providers can treat 30 patients at a given time; during the second year, they may prescribe for 100 patients; and during the third year, they may prescribe for 275 patients.

Buprenorphine Induction and Administration

Online webinars describing different models of buprenorphine induction are available for clinician CME credit. Up-to-date resources and guidance can be found at: https://pcssmat.org/models-of-buprenorphine-induction/. General guidance is provided below.

Patients are generally started on buprenorphine/naloxone once they present with mild to moderate opioid withdrawal symptoms (as assessed with the Clinical Opioid Withdrawal Scale [COWS]. See Appendix 6.3). The timing of a patient’s withdrawal will depend on the half-life of the last opioid taken. Given the variability in half-life for illegally produced fentanyl, patients should be monitored closely and started on buprenorphine/naloxone when they have at least moderate opioid
withdrawal symptoms.

Buprenorphine tablets and films are found in two formulations: combined with naloxone, and a monoproduct formulation (i.e., without naloxone). The combination formulation is designed to prevent misuse because if it is injected, naloxone blocks the opioid receptor, precipitating withdrawal symptoms. Generally, pediatric and adolescent providers should prescribe the combined formulation unless it is contraindicated because of an allergy. Many clinicians conduct an in-office observed induction for adequate dosing, and parental/family education and monitoring for adverse effects of sedation and drowsiness.

The PCSS MAT Guidance Document for Adolescents and Young Adults notes that treatment dosing ranges from 2–24 mg/day with 59% of patients stabilized on 9–16 mg/day. As in adults, it is optimal to adjust buprenorphine dose until the patient no longer reports withdrawal symptoms or cravings
for opioids.

One approach could be an initial dose of 2–4 mg, followed by additional 2 mg dose every 30–60 minutes until a patient’s COWS score is less than 5, or until a max dose of 8 mg has been reached. Patients can then be sent home with an additional 4 mg to take in the evening, with most individuals maintained on an 8–16 mg daily dose. 

Naltrexone

Naltrexone is an opioid antagonist with high affinity for the opioid receptor. It prevents opioids from binding to the mu opioid receptor, reducing the risk of overdose and blocking the reinforcing effects of opioid use. Naltrexone may also reduce cravings for opioids in some patients. It can be administered in daily oral doses, or more commonly by a monthly injection. Ongoing clinical trial research is exploring the use of naltrexone home delivery systems, psychosocial treatment, and contingency management in the provision of naltrexone to young adults (see ClinicalTrials.gov NCT03306368). No certification must be obtained by providers for prescription of naltrexone; however, at the time of publication it is not FDA approved for patients under 18 years old. Evidence from adult studies suggests that naltrexone is effective at reducing substance use and may match the clinical success of buprenorphine. However, trials considering adolescents are lacking.

Despite this, some evidence supports the off label use of naltrexone in adolescents under 18 years old. In a preliminary case-series with 16 adolescents and young adults with an OUD (mean age 18.5 years), 63% remained in treatment for at least 4 months after beginning a treatment regimen of extended-release naltrexone. Additionally, 56% had substantially decreased opioid use and improved in at least one psychosocial domain. In another observational study, adolescents and young adults who received naltrexone were approximately half as likely to be lost to treatment follow-up compared to youth receiving only behavioral health services for OUD.

Naltrexone Induction and Administration

The long-acting injectable form of naltrexone is administered once monthly. This formulation may encourage treatment engagement in youth; however, it may also prolong periods of non-involvement with medical care and retention rates (compared to buprenorphine). Given the loss of tolerance with prolonged naltrexone use, patients who miss their monthly injection and relapse on opioids are at an elevated risk of overdose. Therefore, clinician judgement should be exercised and individualized to the patient, with regards to a patient’s risk for loss to follow-up. This can include consideration of the patient’s housing and financial stability, social supports, individual/familial motivation, and likelihood of remaining engaged in treatment.

Suggested Schedule for starting naltrexone:
  • 3-6 days after most recent use of short-acting opioids, such as heroin, or short-acting prescription opioids (oxycodone, morphine, codeine, hydrocodone, hydromorphone, oxymorphone)
  • 7-10 days after most recent use of long-acting opioids, such as methadone, buprenorphine, and long-acting prescription opioids (hydrocodone extended release[ER], morphine ER, oxycodone ER, tramadol ER, oxymorphone ER)

When initiating treatment with the long-acting injectable form of naltrexone, generally tolerability
is first assessed with oral naltrexone. It is important for providers to educate young people that they are at risk for precipitated opioid withdrawal if naltrexone is taken when opioids are still in their  system. To minimize the risk of precipitated opioid withdrawal the choice of when to start naltrexone should be determined based on the half-life of the opioid that a young person has been using.

Many clinicians initially prescribe several days to one week of oral tablets to monitor tolerability before transitioning to the monthly injection. Other clinicians provide a single oral dose in
an observed clinical setting, and if tolerated by the patient, provide a long-acting injection approximately two hours later.

Choosing a Medication

There is no definitive algorithm to guide medication choice although there are some general guidelines that providers, patients, and families can follow. First, providers can give patients and families information about the different medication choices, including how the medication works, the evidence for its use, and potential side effects. In addition, providers can provide tailored advice based on the individual patient. Please see the PCSS course, “Choosing a Medication Assisted Treatment” for more information.
https://pcssnow.org/education-training/training-courses/introduction-to-medicationassisted-treatment-mat/ 

Monitoring 

While on medication, toxicology tests can be used to ascertain concurrent substance and opioid use, and medication adherence. If a toxicology screen tests negative for buprenorphine for a patient who is prescribed medication, providers should not immediately assume that the patient is not taking their medication. Low-dose buprenorphine can be difficult to detect with toxicology testing (particularly through saliva). Therefore, clinicians should supplement lab tests with conversations with patients to understand their experience taking MAT and may consider checking metabolites. These conversations can be an opportunity to discuss risks of ongoing substance use while on buprenorphine, since concurrent alcohol and benzodiazepine use can lead to excessive somnolence, and in high doses, potential overdose. They can also be a place to discuss desire to switch among forms of MAT if unhappy with one medication.

Duration of Treatment

There is no specific evidence on the optimal duration of treatment for either naltrexone or buprenorphine. Extant evidence suggests that adolescents and young adults experience more positive outcomes with longer use of medications and engagement in care. At the same time, prolonged exposure to opioids has a negative impact on the developing brain. The tradeoff of continuing medication should be made with consideration of severity of substance use disorder and risk of overdose. Shared decision making with the patient, and the parents when possible, should guide treatment. Length of treatment should be determined based on clinical judgement and progress of patient, in collaboration with family/support system, if appropriate. If future tapering is desired, medications should be tapered slowly to avoid withdrawal and return of cravings.
Once a medication has been discontinued, continuing care, including behavioral health treatment and primary care, is still important.

Special Population

Adolescents and young adults should have access to evidence-based care, regardless of their involvement in justice and social systems. Adolescents with chronic pain conditions, currently homeless, LGBTQ-identifying, in government custody, or currently pregnant are all candidates for MAT.

Youth in DCF/DYS Custody

Youth in the care of the Massachusetts Department of Children and Families (DCF) and/or Department of Youth Services (DYS) should still receive care for their opioid use disorder, with decisions made in collaboration with government case workers. DCF can give consent for a minor to receive medical treatment. However, minors in Massachusetts DO NOT need to have parental or legal guardian consent to agree to treatment for OUD, and adolescents in DCF custody do not require DCF
approval or consent for treatment.

If a medical provider chooses to treat an adolescent under DCF custody only after obtaining consent from the Department, DCF may consent for the minor, provided that the Department is not consenting to the administration of antipsychotic medication as part of the treatment of substance
use disorder.

DYS policy states that patients should be transitioned to outpatient treatment services if deemed appropriate by medical providers. 

Pregnancy

Opioid use during pregnancy has increased risks, including fetal growth restriction, placental abruption, preterm labor, and possible fetal death.

Opioid agonist pharmacotherapy during pregnancy has been shown to reduce the risk of obstetrical complications and have better outcomes both for mother and baby. Babies born to mothers who were treated with methadone or buprenorphine may develop neonatal opioid withdrawal. Historically, methadone has been the first-line medication choice for treating OUD in pregnant women, but buprenorphine has been shown to be equally safe and effective. Increasingly, providers are continuing naltrexone during pregnancy for women stable on the medication prior to pregnancy.

Patients who are pregnant with active OUD or are on MAT should be referred to healthcare professionals experienced in providing prenatal care to patients with OUD and identifying and managing neonatal opioid withdrawal syndrome in infants. State licensed and/or contracted providers who have relationships with clients that last longer than 30 days are expected to make sure that all clients who are pregnant or parenting an infant have a Plan of Safe Care (POSC). Other perinatal service providers and healthcare providers are encouraged to screen pregnant and parenting women for substance use and offer either to coordinate a POSC for the client/patient or refer her to another provider who will coordinate the POSC. For more information on POSC, go to: http://healthrecovery.org/safecare/ 

Relapse and Overdose Prevention

Relapse Risks

Alternating periods of recovery and relapse are common for individuals with OUD. Patients on MAT who relapse and/or show evidence of use of other illicit substances will need additional support. Providers may also consider discussing options for more intensive SUD treatment (intensive outpatient program, partial hospital program, residential treatment) if indicated. It is recommended that healthcare providers continue support from SUD treatment providers for patients on MAT who relapse.

Overdose Risk

Patients develop tolerance to opioids with regular use, requiring larger or more frequent amounts of a substance to continue experiencing reinforcing effects. When individuals begin MAT after prolonged opioid use, they can lose tolerance to opioids. While opioid agonists methadone and buprenorphine maintain activity at the mu opioid receptor, opioid antagonist naltrexone prevents all activity, increasing the loss of tolerance. If a patient relapses on the same dose they used prior to treatment, they are at an elevated risk of overdose.

Caregiver Education

Naloxone Prescription

Naloxone is an FDA-approved antidote to opioid overdose and the fast-acting antagonist of choice to reverse acute opioid toxicity. It can be administered intramuscularly, subcutaneously, or intravenously. Naloxone can be prescribed to patients, caregivers, and community members. Massachusetts pharmacies allow anyone to purchase naltrexone without a prescription. The proper technique for administration should be reviewed with patients regardless of their MAT
status, as well as caregivers.

Injection Drug Use Harm Reduction

Back to top