Frequently Asked Questions

An antagonist is a drug that blocks opioids by attaching to the opioid receptors without activating them. Antagonists cause no opioid effect and block full agonist opioids. Examples are naltrexone and naloxone. Naloxone is sometimes used to reverse a heroin overdose.

Buprenorphine is a partial agonist meaning, it activates the opioid receptors in the brain, but to a much lesser degree then a full agonist.

Buprenorphine also acts as an antagonist, meaning it blocks other opioids, while allowing for some opioid effect of its own to suppress withdrawal symptoms and cravings.

This is why it would be misleading to classify buprenorphine as a replacement therapy. It would be equally misleading to classify it solely as an opioid blocker. Buprenorphine is in a category of its own and therefore should not be seen as “replacement” for anything else.

How do opioids work in the brain?
Opioids attach to receptors in the brain. Normally these opioids are the endogenous variety that are created naturally in the body. Once attached, they send signals to the brain of the "opioid effect" which blocks pain, slows breathing, and has a general calming and anti-depressing effect. The body cannot produce enough natural opioids to stop severe or chronic pain nor can it produce enough to cause an overdose.

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Are there exceptions when Buprenorphine may be administered by a practitioner without the DATA 2000 waiver?
Under the Narcotic Addiction Treatment Act of 1974, all practitioners who use narcotic drugs for treating opiate addiction must obtain a separate registration under 21 U.S.C. Section 823(g)(1) or a DATA 2000 Waiver under 21 U.S.C. Section 823(g)(2). However, according to the Drug Enforcement Administration (DEA), an exception to the registration requirement, known as the "three-day rule" (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program or certified as a “waivered DATA 2000 physician,” to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions: 1) not more than one day’s medication may be administered or given to a patient at one time; 2) this treatment may not be carried out for more than 72 hours; and 3) this 72-hour period cannot be renewed or extended.

How does Buprenorphine work in the brain?
Opioids attach to receptors in the brain, with three main effects; reduced respiration, euphoria, decreased pain. The more opioids ingested the more of an effect. The process of opioids binding to the opioid receptors can be thought of as a mechanical union, the better the fit the more the opioid effect. Buprenorphine is different. It too binds to the receptors, however, without a perfect fit. As a result the Buprenorphine tends to occupy the receptors without all of the opioid effects. The receptor is tricked into thinking it has been satisfied with opioids without producing the feeling of euphoria, and without causing respiratory depression. This, in turn, prevents that receptor from joining with full opioids; therefore if the patient uses heroin or painkillers, they will not be able to experience any additional effect. Buprenorphine tends to stay with the receptors, blocking them, much longer then opioids do. This stickiness, is what makes Buprenorphine last so long, up to 3 days.

Are there other uses for Buprenorphine?
The Food and Drug Administration (FDA) has approved Buprenex® ( an injectable formulation of buprenorphine) to treat pain. However, by law, Buprenex cannot be used to treat opioid dependence(addiction), even by DATA-2000 wavered physicians. (Buprenex PI)

What exactly are opioid receptors?
These are protein molecules that exist on the surface of some nerve cell membranes. They provide a way for the body to experience the effects of opioids.

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What is addiction?
To understand fully you must be aware of the difference between tolerance, physical dependence, and addiction:

What is withdrawal?
Withdrawal syndrome consists of a predictable group of signs and symptoms resulting from abrupt removal of, or a rapid decrease in the regular dosage of, a psychoactive substance. The syndrome is often characterized by over activity of the physiological functions that were suppressed by the drug and/or depression of the functions that were stimulated by the drug. In other words, opposite of what the drug did. If the drug suppressed depression then the person would be depressed while in withdrawal. If the substance suppressed pain then the person will experience pain while in withdrawal.

What treatments have been used for opioid addiction?
For the past 40 years there have been only a few treatments: abstinence, cold turkey, replacement therapy and medical detox. All of these treatments do little to solve the physical problem of addiction. Some replacement treatments such as methadone were introduced to reduce crime (introduced in Government-funded clinics during the Nixon Administration as 'harm reduction' for returning Vietnam Vets who became addicted to opiates overseas and also to reduce the crime statistics from the rising use of heroin in this country).(see our page on drug laws) The plan was this: if patients could get a long-acting opioid (24 hours), they would not need to get drugs as often as with heroin (4-6 hours) and thus, less crime would be committed in the procurement of the drugs and it would be possible for those to conduct fairly normal lives. It did work, however it did not stop the progression of the addiction. As time went on patients would need more and more methadone to feel the same way. It was very difficult to convince someone to decrease their dose and most people did not become drug free. They would remain addicted but now to methadone, an improvement but still an addiction.

What are examples of treatment options?
1. Buprenorphine treatment

What are the pros and cons of treatment with Methadone?
Pros:

• More than 30 years of experience in treating opioid addiction
• Daily visits give more structure to patients who need it
• Cost is usually less and may be calculated on a sliding scale based on income
• The opportunity to meet many people who share the same addiction
• Group counseling
• It is an opioid so it is able to stop the withdrawal symptoms
• It lasts for at least 24 hours
• There is no legal limit to how many patients a methadone clinic can treat
• With continued use, there is a mandatory dose increase schedule which helps patients overcome persistent cravings

• It is possible to continue to use illicit opioids while on methadone
• Patients complain that it is very difficult to detox from methadone
• Methadone treatment follows a strict protocol which makes some patients feel that they have no control over their own treatment
• Shows up in urine testing for employment
• Daily visits to the methadone clinic may be difficult for some patients who have jobs, especially when traveling distance is great.
• Daily visits make overnight travel difficult for both business and pleasure
• Some claim that it makes them feel "foggy" or like they have "cotton in their head"
• Some people find it difficult to overcome self-esteem issues in a clinic environment.

What are the pros and cons of inpatient detoxification?
Medically supervised withdrawal from opioids is the first step to treatment, but it does not constitute treatment in and of itself. It is difficult to find data reporting the long-term outcomes of patients who have been treated with inpatient detoxification.

What are the pros and cons of detoxification under anesthesia (Rapid Detox)?

"In general, the data do not support using general anesthesia during detoxification," said Herbert Kleber, M.D., vice chair of APA's Council on Addiction Psychiatry and a coauthor of the report. "The critical thing is not what happens during detox, but what happens after, and we found no difference between the groups. In addition, there were serious life-threatening adverse effects in the anesthesia group."(Psychiatry News October 7, 2005)

What are the pros and cons of quitting on your own, also known as "cold turkey"?
It is not treatment for the brain disease of addiction; it does not take away the cravings, it does not address the problems that lead to the addiction in the first place; and after a period of time, it becomes too difficult to fight the cravings. Only 5% of the patients who quit cold turkey are successful long term.

Why is it called "quitting cold turkey"?
One symptom of opioid withdrawal is goose flesh (small bumps on the surface of the skin usually resulting from being cold). When someone discontinued opioids abruptly (cold turkey), they would exhibit these visible symptoms and it was noticed their skin looked like a cold turkey.

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Why is counseling an important tool in the treatment process?
Physical connections create pathways in the brain that can be altered when we learn something new. These changes to the brain can be seen with medical imagery. With long term difficult things like learning to play a musical instrument, these changes can be permanent. Addiction is a learned behavior that changes the brain as well. The brain becomes conditioned to want the substance. Through counseling and other behavioral modification we can actually, in some cases, change the brain physically. By changing our environment, starting a new job, new hobbies and friends, all will alter our brain in some way. It is possible to undo some of the changes that occurred while addicted. Therapy will recondition the brain closer to pre-addiction status. This will better prepare the patient for a time when they may no longer require medication.

Who can prescribe Buprenorphine?
Any physician with a special "X" number issued by the DEA. The way the law is written, any doctor can prescribe Suboxone for treating pain, however the FDA has not granted approval for Suboxone to be used for pain, so it would be an off-label prescription. However there exists other restrictions for those who want to prescribe it for opioid addiction treatment (what the FDA approved it for). Doctors must take an 8-hour class on addiction treatment, or already possess such credentials, and then apply for a special DEA#. Once they obtain their # they are limited to treating only 30 patients at a time. (see our 30 patient limit page)

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Is buprenorphine addictive?

People can become addicted to anything that causes pleasure; consider gambling, sex, food, and internet. There is even a condition where patients drink so much water they thin their blood, causing some level of intoxication (hyponatremia). They are addicted to this behavior, although water is not considered addictive. Substances and activities all have some potential addiction liability. Many factors including genetics and environment contribute to someone’s potential of becoming addicted

The brain has a natural reward system that helps us to learn that things that cause pleasure are good and should be repeated. This helps our species survive by reinforcing the desire for food and sex. These activities initiate a biochemical sequence and release dopamine in the brain. This feels good and is reinforced when repeated. Some substances can trick the brain and initiate the same biochemical sequence, but to a greater and unnatural degree. The brain senses this activity as the most pleasurable and hence the most necessary for survival, and creates a memory of the activity and cravings for more. The cycle reinforces itself and can lead to addiction (uncontrollable dangerous compulsive behavior)

Research has shown that substances that reach the brain faster have a higher potential for addiction. Also substances that provide a stronger effect cause more reinforcement. This begins a cycle of euphoria then craving then euphoria, craving and so on. Each time the cycle completes it reinforces a memory in the brain, the more frequent the cycle the more reinforcing.

The potential for addiction has to do with 3 main things, the speed of the onset, the level of reinforcement (pleasure), and the duration of action. IV heroin, is fast acting, strong euphoria, short duration. This gives it a high potential for addiction. Drugs with short intense cycles provide more potential for addiction than drugs with long “flatter” cycles.

Buprenorphine has a slow onset, mild effect, and long duration, which puts it at some risk of being addictive, more than water, but less than full agonist opioids, like heroin, morphine, oxycodone, and hydrocodone.

In countries where only Subutex is available (buprenorphine without the naloxone safeguard added), some people have injected their buprenorphine, thus decreasing the onset time and increasing euphoria, this in turn increased the potential for addiction and thus more people became addicted to it. The risk of addiction is less when taken sublingually as directed.

Although there is the potential for addiction to buprenorphine, the risk is low. Few people develop the dangerous uncontrollable compulsion to buprenorphine that we know as addiction. Buprenorphine will maintain a level of physical dependence to opioids but that is manageable and can be resolved with a gradual taper once the patient is ready.

Can someone switch from methadone to buprenorphine?
It is best to SLOWLY reduce your therapeutic dose of Methadone to 30 mg a day or less for at least a week, before discontinuing it completely for at least 36 hours before starting Buprenorphine. You MUST be in mild to moderate withdrawal before you take your first dose of Buprenorphine. If you are doing well in Methadone treatment it may not be advisable to change treatments at all unless you and your doctor determine it is in your best interest.

Does insurance cover it?
Most insurance companies cover the medication itself. However many people choose to pay for it themselves to keep their condition private. There are some doctors that will only take cash. It pays to shop around. A doctor can choose what if any insurance they will accept (in some states). Every week more doctors are certified to prescribe. Some patients start with the first doctor they can get an appointment with,then find a more reasonably priced one later.

What if I miss a dose?
If you miss a dose and remember it hours later, take it upon remembering. If you forget until it is close to the time of the next day's dose, do not take a double dose. Not because you will take too much but rather you will just be wasting it, due to the ceiling effect. After being on treatment for a relatively short period of time you will feel so normal it may be difficult to remember unless you tie taking your medication to an activity you do every day at the same time. For example, after you have coffee or orange juice in the morning, or while reading the newspaper.

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Why are doctors limited to only helping 30/100 people at a time?
DATA-2000 was written to allow for a variety of new drugs to be used in an office based setting by certified physicians. In 2002 Suboxone/Subutex became the first drugs that physicians could use and as of August 2007 are still the only approved medications. Without knowing the abuse potential or other social impact of these yet to be discovered drugs for addiction safeguards were built in the law. Many patients and physicians have complained that the law is too restrictive because almost every physician can prescribe potentially addictive medication but once a patient becomes addicted physicians are restricted on how many they can treat for addiction.

What if I need pain medication for surgery, or acute pain?
You will still be able to be treated for pain with elective dental or surgical procedures. Your doctors should speak with each other about the plan. They will likely stop your Buprenorphine medication, at least 36 hours before the procedure, and then when you are ready to go back on Buprenorphine you will need to be re-induced, which means stopping your pain medicine, experiencing mild withdrawal (for a very short time) and restarting your Buprenorphine.

In case of emergency, for those maintained on Buprenorphine

We never know what could happen. What if there is an emergency and you need to be treated for pain? Worse yet what if you are unconscious? A potential problem is you could be unnecessarily under-treated for pain. Since many doctors out there are still unfamiliar with Buprenorphine, there are a few documents that will be helpful. We suggest you print out a few of these and tell a loved one or your “in case of emergency” person, where they are.

• Your Bupe doctor’s name and phone number.A list on any other medications you are on or conditions you may have along with all insurance info and any other relevant medical or personal information
• This article http://www.annals.org/cgi/reprint/144/2/127.pdf you can highlight the part about buprenorphine and pain treatment.
• The PCSS Mentor brochure, the docs can call and speak with a buprenorphine expert http://www.naabt.org/documents/pcssbrochure.pdf
• PCSS-clinical guidelines- Treating acute pain in buprenorphine maintained patients: http://www.naabt.org/documents/PCSSAcutePainGuidance.pdf
• The buprenorphine illustration, for a quick understanding http://www.naabt.org/collateral/How_Bupe_Works.pdf
• A print out of the 72 hour rule, for dispensing buprenorphine in emergencies: http://www.naabt.org/documents/three-day-rule.pdf
• This article explains practical treatment issues http://www.naabt.org/documents/Practical_Conciderations%20.pdf

Keep this in a folder, jump drive, or CD, just in case of emergency. Hopefully it will never be needed.

Most of these files are PDF files and require the standard reader to view them. This comes with newer computers but if these files don’t open for you, you can download the free and virus free reader here. This is something you only have to do once and will allow you access to all kinds of information as the pdf file format is becoming more and more popular. http://www.adobe.com/products/acrobat/readstep2.html

How soon can a work schedule be resumed?
It is recommended to take the first day of treatment off. Some are able to work even on Day One. Certainly after Day One, you should be able to work with greater attentiveness and clarity than before starting treatment. The transition from addictive substance to Buprenorphine is usually painless and most patients experience no adverse physical effects. In fact most say that they feel normal again, like they were never on drugs at all.

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What is the DATA 2000?
The Drug Addiction Treatment Act of 2000 (DATA 2000)

What is the Naloxone for?

(In relation to the Buprenorphine/Naloxone Combination product(Suboxone®))
Because of reports of misuse of buprenorphine by injection in other countries, the buprenorphine/naloxone combination was developed for the U.S. market. This combination was thought to decrease the potential for diversion and misuse of buprenorphine because, if injected, the naloxone should precipitate withdrawal in the patient.

Sublingually, naloxone has a relatively low bioavailability while buprenorphine has good sublingual bioavailability.
Both have poor bioavailability through the GI tract. Taken sublingually, as directed, naloxone is clinically insignificant and has virtually no effect. (Except in rare cases of an allergic reaction or naloxone hypersensitivity.)

The safety and efficacy profile of sublingual buprenorphine/naloxone appears to be equivalent to that of buprenorphine alone (Harris et al. 2000).

Sources:

Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction
A Treatment Improvement Protocol TIP40 TIP 40, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment
www.samhsa.gov, page 23

FDA. Full Prescribing information on Subutex® (buprenorphine)/Suboxone® (buprenorphine/naloxone)
www.fda.gov/cder/foi/label/2002/20732lbl.pdf

naloxone: Brand name: Narcan. An opioid antagonist, similar to naltrexone, that works by blocking opioid receptors in the brain, thereby blocking the effects of opioid agonists (e.g., heroin, morphine). Naloxone has poor bioavailability when taken sublingually. Naloxone has a high afinity to the mu opioid receptor, yet not as high of an affinity as buprenorphine, at the mu receptor. source: http://www.naabt.org/glossary.cfm#N

In the absence of narcotics or agonistic effects of other narcotic antagonists it exhibits essentially no pharmacologic activity. Naloxone has not been shown to produce tolerance nor to cause physical or psychological dependence.
In the presence of physical dependence on narcotics Naloxone will produce withdrawal symptoms.
Source: http://www.drugs.com/pro/naloxone.html

Is Buprenorphine safe for people with a co-existing psychological illness?
Many people use drugs because they are knowingly or unknowingly self-medicating for an underlying psychiatric condition. In either case, once the addiction is being treated the psychiatric condition will surface and require treatment. This patient would be well served by getting Buprenorphine treatment through an addiction psychiatrist or a psychiatrist who specializes in the illness with which the patient is afflicted.

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What are the statistics with regard to opioid addiction and use in the US?
According to the January 2003 Drug Abuse Warning Network (DAWN) Report published by SAMHSA's OAS, the incidence of abuse of prescription opioid pain medications (also known as narcotic analgesics) such as hydrocodone and oxycodone has risen markedly in recent years (Crane 2003). From 1994 to 2001, there was a 117% increase in emergency room visits related to opioid analgesic abuse. According to the DAWN Mortality Data Report for 2002 (SAMHSA 2002), hydrocodone ranked among the 10 most common drugs related to deaths in 18 cities. Oxycodone ranked among the 10 most common drugs related to deaths in 19 cities, including Philadelphia (88), Baltimore (34), Boston (34), Phoenix (34), and Miami (28).

What is Precipitated withdrawal?
Precipitated withdrawal can occur when an antagonist (or partial antagonist, such as buprenorphine) is administered to a patient dependent on full agonist opioids. Due to Buprenorphine’s high affinity but low intrinsic activity at the mu receptor, the partial antagonist displaces agonist opioids from the mu receptors, without activating the receptor to an equivalent degree, resulting in a net decrease in agonist effect, thus precipitating a withdrawal syndrome.

Naltrexone? What is it and what does it do?
Naltrexone is like naloxone except Naltrexone can be taken orally, while naloxone is only effective if injected. Both medications have a similar effect once they have entered the body. Naltrexone was first synthesized in 1965. It was approved by the FDA in 1984 for preventing relapse in opioid addicted patients. Later in 1994 the FDA approved it to treat alcoholism, it tends to reduce cravings for alcohol. Naltrexone binds to the opioid receptors stonger then other opioids (except buprenorphine) this results in near complete blocking of opioids. Naltrexone is not used extensivley because the retention rate of patients is very small. Unlike buprenorphine Naltrexone does not activate the opioid receptors at all, so any lingering withdrawal, or pain from a comprimised endogenous opioid system will still exist.

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Where can my doctor get help in using buprenorphine?
www.pcssmentor.org The SAMHSA-funded PCSS is designed to assist practicing physicians, in accordance with the Drug Addiction Treatment Act of 2000, in incorporating into their practices the treatment of prescription opioid and heroin dependent patients using buprenorphine.

Is my medical information confidential?

Confidentiality of Alcohol and Drug Dependence Patient Records (summary)

The confidentiality of alcohol and drug dependence patient records maintained by a practice/program are protected by federal law and regulations. Generally, the practice/program may not say to a person outside the practice/program that a patient attends the practice/program, or disclose any information identifying a patient as being alcohol or drug dependent unless:

• The patient consents in writing;
• The disclosure is allowed by a court order, or
• The disclosure is made to medical personnel in a medical emergency or to qualified personnel for research, audit, or practice/program evaluation.

Violation of the federal law and regulations by a practice/program is a crime. Suspected violations may be reported to appropriate authorities in accordance with federal regulations.

Privacy and Your Health Information Fact Sheet:

Your Health Information Privacy Rights Fact Sheet:

THE CONFIDENTIALITY OF ALCOHOL AND DRUG ABUSE PATIENT RECORDS REGULATION AND THE H.I.P.A.A. PRIVACY RULE: SAMHSA

Code of Federal Regulations Title 42 Part 2 (42 CFR Part 2)

Summary of Patients' Right to Privacy (suboxone.com)

How to file a health information privacy complaint

Does buprenorphine show up in an employer drug screening?