Frequently Asked Questions
In order to be admitted to an OTP that utilizes both methadone and buprenorphine, a person must meet the Diagnostics and Statistics Manual version 5 (DSM5) criteria for opioid use disorder (OUD). In order to receive methadone, a person must also meet the following criteria: a minimum of one year of addiction to opioids, as well as current evidence of opioid use disorder. Special circumstances apply to opioid dependent pregnant women, those recently released from a penal institution, and those who have been discharged from a program within the last two years, and they may be admitted without demonstration of the one-year minimum; and the applicant must be over 18 years of age, or if the applicant is under 18, (s)he must have parental consent and demonstrate at least two prior treatment episodes in either drug free treatment or short-term tapering.
Medication-assisted treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders. This combination of services assists a person in achieving long-term and stable recovery. Medications used in MAT are approved by the Food and Drug Administration (FDA) and OTPs are clinically driven and tailored to meet each patient’s needs.
Research shows that a combination of medication and therapy can successfully treat these disorders, and for some people struggling with problematic use MAT can help sustain recovery. MAT is also used as a risk reduction measure to prevent or reduce opioid overdose.
Medication assisted treatment is voluntary and available to persons of any sex, ethnicity, and physical or mental condition, including pregnant women and mentally ill individuals with OUD.
*a portion of this information can be found at SAMHSA.gov
Opioid Agonists and Partial Agonists (Maintenance Medications)
Studies show that people with opioid use disorder who follow detoxification with complete abstinence are very likely to relapse, or return to using the drug. While relapse is a normal step on the path to recovery, it can also be life threatening, raising the risk for a fatal overdose. Thus, an important way to support recovery from heroin, fentanyl, or prescription opioid use disorder is to maintain abstinence from those drugs. Someone in recovery can also use medications that reduce the negative effects of withdrawal and cravings without producing the euphoria that the original drug of abuse caused. Methadone and buprenorphine are medications approved for this purpose.
Methadone is a synthetic opioid agonist that eliminates withdrawal symptoms and relieves drug cravings by acting on opioid receptors in the brain—the same receptors that other opioids such as heroin, morphine, fentanyl, and opioid pain medications activate. Although it occupies and activates these opioid receptors, it does so more slowly than other opioids and, in an opioid-dependent person, treatment doses do not produce euphoria. It has been used successfully for more than 70 years to treat opioid use disorder and must be dispensed through specialized opioid treatment programs.
Buprenorphine is a partial opioid agonist, meaning that it binds to those same opioid receptors but activates them less strongly than full agonists do. Like methadone, it can reduce cravings and withdrawal symptoms in a person with an opioid use disorder without producing euphoria. Buprenorphine has been available for opioid use disorders since 2002 as a tablet and since 2010 as a sublingual film. The FDA approved a 6-month subdermal buprenorphine implant in May 2016 and a once-monthly buprenorphine injection in November 2017. These formulations are available to patients stabilized on buprenorphine and will eliminate the treatment barrier of daily dosing for these patients.
Naltrexone is an opioid antagonist, which means that it works by blocking the activation of opioid receptors. Instead of controlling withdrawal and cravings, it treats opioid use disorder by preventing any opioid drug from producing rewarding effects such as euphoria. Its use for ongoing opioid use disorder treatment has been somewhat limited because of poor adherence and tolerability by patients. In 2010, an injectable, long-acting form of naltrexone (Vivitrol®), originally approved for treating alcohol use disorder, was FDA-approved for treating opioid use disorder. Because its effects last for weeks, Vivitrol® is a good option for patients who do not have ready access to health care or who struggle with taking their medications regularly.
Because each medication works differently, a treatment provider should decide on the optimal medication in consultation with the individual patient and should consider the patient’s unique history and circumstances.
Opioid treatment programs are the only providers authorized to utilize all three FDA approved medications to treatment opioid use disorder.
*Data and Reference Information Obtained from NIDA.gov
Abundant evidence shows that methadone, buprenorphine, and naltrexone all reduce opioid use and opioid use disorder-related symptoms, and they reduce the risk of infectious disease transmission as well as criminal behavior associated with illicit substance use. These medications also increase the likelihood that a person will remain in treatment, which itself is associated with lower risk of overdose mortality, reduced risk of HIV and HCV transmission, reduced criminal justice involvement, and greater likelihood of employment.
Methadone is the medication with the longest history of use for opioid use disorder treatment, having been used since 1947. A large number of studies support methadone’s effectiveness at reducing opioid use. A comprehensive Cochrane review in 2009 compared methadone-based treatment (methadone plus psychosocial treatment) to placebo with psychosocial treatment and found that methadone treatment was effective in reducing opioid use, opioid use-associated transmission of infectious disease, and crime. Patients on methadone had 33 percent fewer opioid-positive drug tests and were 4.44 times more likely to stay in treatment compared to controls. Methadone treatment significantly improves outcomes, even when provided in the absence of regular counseling services; long-term (beyond 6 months) outcomes are better in groups receiving methadone, regardless of the frequency of counseling received.
Buprenorphine was first approved in 2002 and is effective for the treatment of opioid use disorders, is effective, has some studies showing high relapse rates among patients tapered off of buprenorphine compared to patients maintained on the drug for a longer period of time.
A Swedish study compared patients maintained on 16 mg of buprenorphine daily to a control group that received buprenorphine for detoxification (6 days) followed by placebo. All patients received psychosocial supports. In this study, the treatment failure rate for placebo was 100 percent vs. 25 percent for buprenorphine. More than two opioid-positive urine tests within 3 months resulted in cessation of treatment, so treatment retention was closely related to relapse. Of patients not retained in treatment, there was a 20 percent mortality rate.
To be effective, buprenorphine must be given at a sufficiently high dose (generally, 16 mg per day or more). Some treatment providers wary of using opioids have prescribed lower doses for short treatment durations, leading to failure of buprenorphine treatment and the mistaken conclusion that the medication is ineffective.
Notably, flexible dose regimens of buprenorphine and doses of buprenorphine of 6 mg or below are less effective than methadone at keeping patients in treatment, highlighting the need for delivery of evidence-based dosing regimens of these medications.
Naltrexone was initially approved for the treatment of opioid use disorder in a daily pill form. It does not produce tolerance or withdrawal. Poor treatment adherence has primarily limited the real-world effectiveness of this formulation. As a result, there is insufficient evidence that oral naltrexone is an effective treatment for opioid use disorder. A newer form of extended-release injectable naltrexone is administered once monthly, which removes the need for daily dosing. While this formulation is the newest form of medication for opioid use disorder, evidence to date suggests that it is effective in certain populations in some circumstances. While the oral formulation will also block opioid receptors, only the long-acting injectable formulation is FDA approved as MAT.
To reduce the risk of withdrawal symptoms caused by OUD, patients should wait at least 7 days after their last use of short-acting opioids and 10 to 14 days for long-acting opioids, before starting naltrexone.
Patients on naltrexone, who discontinue use or relapse after a period of abstinence, may have a reduced tolerance to opioids. Therefore, taking the same, or even lower doses of opioids used in the past can cause life-threatening consequences.
*Data and Reference Information Obtained from NIDA.gov and SAMHSA.gov
Because maintenance medications (methadone and buprenorphine) are themselves opioids and are able to produce euphoria in people who are not dependent on opioids, many people have assumed that this form of treatment just substitutes a new substance use disorder for an old one. This belief has unfortunately hindered the adoption of these effective treatments. In the past, even some inpatient treatment programs that were otherwise evidence-based did not allow patients to use these medications, in favor of an “abstinence only” philosophy.
Although it is possible for individuals who do not have an opioid use disorder to get high on buprenorphine or methadone, these medications affect people who have developed a high tolerance to opioids differently. At the doses prescribed, and as a result of their pharmacodynamic and pharmacokinetic properties (the way they act at opioid receptor sites and their slower metabolism in the body), these medications do not produce a euphoric high but instead minimize withdrawal symptoms and cravings. This makes it possible for the patient to function normally, attend school or work, and participate in other forms of treatment or recovery support services to help them become free of their substance use disorder over time.
The ultimate aim could be to wean off the maintenance medication, but the treatment provider should make this decision jointly with the patient and tapering the medication must be done gradually. It may take months or years in some cases. Just as body tissues require prolonged periods to heal after injury and may require external supports (e.g., a cast and crutches or a wheelchair for a broken leg), brain circuits that have been altered by prolonged drug use and substance use disorder take time to recover and benefit from external supports in the form of medication. In cases of serious and long-term opioid use disorder, a patient may need these supports indefinitely.
In 2005, methadone and buprenorphine were added to the World Health Organization’s list of essential medicines, defined as medicines that are “intended to be available within the context of functioning health care systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.”[SP1]
*Data and Reference Information Obtained from NIDA.gov