Buprenorphine Detox - Rehab Detox Treatment for Opiate Addiction

Background History of Buprenorphine

Treating people for opioid addiction has been shown to be effective in helping them return to work and achieve productive lives. On Oct. 8, 2002, the U.S. Food and Drug Administration approved buprenorphine as a controlled Schedule III drug for the treatment of opioid dependence. Certified physicians (see below) are now able to prescribe buprenorphine to treat heroin and other forms of opioid dependence in their private offices and in clinics, as well as in traditional drug treatment programs. Compared with methadone, buprenorphine has a lower risk for abuse and dependence,fewer side effects, and a longer duration of action.

About Buprenorphine

Buprenorphine, a derivative of opium, has been marketed in the United States for many years as a pain relief treatment. With the recent FDA approval of buprenorphine for use in the treatment of opioid dependency, buprenorphine is now available as a prescription medication under the brand names of Subutex7 and Suboxone7, both of which are taken sublingually (under the tongue).

How does buprenorphine work?

When taken by a person who is addicted to heroin or another opioid, buprenorphine reduces craving and helps the person remain drug-free. Like methadone, buprenorphine can be used to withdraw from heroin, or it can be used continuously to help keep a person addicted to heroin from using the drug.

What is the difference between Subutex and Suboxone?

The single active ingredient in Subutex is buprenorphine, which decreases the craving for heroin and other opioids. Suboxone is a combination of buprenorphine and naloxone, which reduces drug craving and induces withdrawal when injected.

How is buprenorphine different from methadone?

Compared with methadone, buprenorphine has a relatively lower risk of abuse, dependence, and side effects, and it has a longer duration of action. Because buprenorphine is a partial opioid agonist, its opioid effects, such as euphoria and respiratory depression, as well as its side effects reach a ceiling of maximum effect, unlike with methadone or heroin. For this reason, buprenorphine may be safer than methadone, as long as it is not combined with sedatives such as tranquilizers or alcohol.

Can a physician in a methadone clinic prescribe or dispense buprenorphine for opioid addiction treatment?

Physicians who have received special certification from Federal and State agencies can prescribe and dispense buprenorphine for opioid addiction treatment in any practice setting, including at a methadone clinic.

How does a physician become qualified to use buprenorphine?

Physicians who want to prescribe buprenorphine must complete an 8-hour course or have sufficient experience and qualifications to be certified.

How will buprenorphine be distributed to patients?

Qualified physicians will give patients a prescription for buprenorphine. The patient can then take the prescription to a pharmacy to have it filled. By contrast, methadone can only be distributed at specialized addiction treatment clinics.

What are buprenorphine's side effects?

The side effects of buprenorphine are similar to those of other opioids and may include nausea, vomiting, and constipation. Both buprenorphine and buprenorphine with naloxone can result in the opioid withdrawal syndrome if used by people on high doses of other opioids. Symptoms of opioid withdrawal can include: dysphoria, nausea and vomiting, muscle aches and cramps, sweating, tearing, diarrhea, mild fever, running nose, insomnia, and irritability.

Can buprenorphine be taken while drinking alcohol?

Buprenorphine should not be taken in combination with alcohol. Taking buprenorphine with alcohol increases buprenorphine's respiratory-depressing effects and can be dangerous.

Can buprenorphine be abused?

Because of its opioid effects, buprenorphine can be abused, particularly by individuals who are not physically dependent on opioids. But because its euphoric effects are less than those of other opioids, so is its potential for abuse.

Is buprenorphine safe?

Because of buprenorphine's ceiling effect, an overdose is less likely than with methadone or other opioids. There also is no evidence of organ damage with chronic use of buprenorphine, although some patients experience increases in liver enzymes. Likewise, there is no evidence that buprenorphine causes any significant disruption of cognitive or psychomotor performance. Because information about the use of buprenorphine in pregnant, opioid-dependent women is limited, methadone remains the standard of care for this group.

Opiate Addiction in the United States

Heroin, morphine, and some prescription painkillers (e.g., OxyContin, Vicodin, and Fentanyl) belong to the class of drugs known as opiates. They act on specific (opiate) receptors in the brain, which also interact with naturally produced substances known as endorphins or enkephalins, and are important in regulating pain and emotion. And while prescription painkillers are highly beneficial medications when used as prescribed, opiates as a general class of drugs have significant abuse liability.
Currently, approximately 1 million people in the United States are addicted to heroin (Office of National Drug Control Policy, 2000), and more than 3 million people over the age of 12 have used heroin at least once [National Survey on Drug Use and Health (NSDUH), 2004]. What's more, an estimated 1.4 million people are dependent on or abusing other opiate drugs, including prescription painkillers [NSDUH (Ibid)].
Scientific research has led to effective treatments for opiate addiction:

• In the 1960's, methadone gained recognition as an effective treatment for heroin addiction. Administered daily, methadone treatment is currently regulated so that only specialized clinics can provide it.
• Naltrexone, an opioid receptor blocker, joined the medications inventory in 1984. It proved to be highly effective in reversing the effects of opiate overdose, but poor treatment adherence has hampered its utility to promote abstinence.
• Buprenorphine , the newest medication in our toolkit, is a long-acting partial agonist that acts on the same receptors as heroin and morphine, relieving drug cravings without producing the same intense "high" or dangerous side effects.

These medications, along with effective behavioral treatments and outreach efforts, have not only reduced injection drug use in this country, but have also helped reduce the spread of HIV and Aidsfrom a peak of more than 25,000 new cases in 1993 to fewer than 10,000 cases in 2003.

The Buprenorphine Success Story

NIDA-supported basic and clinical research led to the development of buprenorphine, which culminated in a large NIDA-sponsored, multisite clinical trial demonstrating its effectiveness. The trial showed that, alone or in combination with naloxone, buprenorphine significantly reduced opiate drug abuse and cravings and was a safe and acceptable addiction treatment.

While these products were being developed in concert with industry partners, Congress passed the Drug Addiction Treatment Act (DATA 2000) permitting qualified physicians to prescribe narcotic medications (Schedules III to V) for the treatment of opioid addiction. This legislation created a major paradigm shift by allowing access to opiate treatment in a medical setting rather than limiting it to federally approved Opioid Treatment Programs.

The FDA approved Subutex�® (buprenorphine) and Suboxone�® tablets (buprenorphine/naloxone) in October 2002, making them the first medications to be eligible for prescribing under the DATA 2000. To date, nearly 10,000 physicians have taken the training needed to prescribe these two medications, and nearly 7,000 have registered as potential providers.

Buprenorphine's Pioneering Contributions to Addiction Treatment

• Buprenorphine's novel formulation with naloxone, an opioid antagonist, limits abuse and diversion potential. Scientific breakthroughs led to this formulation, which produces severe withdrawal symptoms in those who inject it to get "high" but no adverse effects when taken orally, as prescribed.
  
  
• Buprenorphine represents a health services delivery innovation. The development of buprenorphine and its authorized use in physicians' offices gives opiate-addicted patients more medical options and extends the reach of addiction medication to remote populations. Its accessibility may even prompt earlier attempts to obtain treatment.

Why is this medication prescribed?

Buprenorphine (Subutex) and buprenorphine and naloxone (Suboxone) are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists, and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.

How should this medicine be used?

Buprenorphine and the combination of buprenorphine and naloxone come as sublingual tablets to taken under the tongue. They are usually taken once a day. To help you remember to take buprenorphine or buprenorphine and naloxone, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take buprenorphine or buprenorphine and naloxone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You will start your treatment with buprenorphine, which you will take in the doctor's office. Your doctor will start you on a low dose of buprenorphine and will increase your dose for several days before switching you to buprenorphine and naloxone. Your doctor may increase or decrease your buprenorphine and naloxone dose until the medication works properly.
Place the tablets under your tongue until they melt. This should take 2 to 10 minutes. If you are taking more than two tablets, either place them all under your tongue at the same time or place them under your tongue 2 at a time. Do not chew the tablets or swallow them whole.
Do not stop taking buprenorphine and naloxone without talking to your doctor. Stopping buprenorphine and naloxone too quickly can cause withdrawal symptoms. Your doctor will tell you when and how to stop taking buprenorphine and naloxone.

Other uses for this medicine  

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking buprenorphine or buprenorphine and naloxone,

• tell your doctor and pharmacist if you are allergic to buprenorphine, naloxone, or any other medications.
• do not take antidepressants ('mood elevators'), narcotic pain killers, sedatives, sleeping pills, or tranquilizers while taking buprenorphine or buprenorphine and naloxone.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: acetaminophen (Tylenol, others); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); carbamazepine (Tegretol); cholesterol-lowering medications (statins); cimetidine (Tagamet); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); dexamethasone (Decadron); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin); ethosuximide (Zarontin);fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir); iron products; isoniazid (INH, Nydrazid); medications for anxiety, mental illness, and seizures; methotrexate (Rheumatrex); metronidazole (Flagyl);nefazodone (Serzone); niacin (nicotinic acid); oral contraceptives (birth control pills); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); troglitazone (Rezulin); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you drink large amounts of alcohol and if you have or have ever had adrenal problems such as Addison's disease; benign prostatic hypertrophy (BPH, enlargement of the prostate gland); difficulty urinating; head injury; hallucinations (seeing things or hearing voices that do not exist); a curve in the spine that makes it hard to breathe; gallbladder disease; stomach conditions; and thyroid, kidney, liver, or lung disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buprenorphine or buprenorphine and naloxone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buprenorphine or buprenorphine and naloxone.
• you should know that buprenorphine or buprenorphine and naloxone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the breathing difficulties that can be caused by this medication.
• you should know that buprenorphine or buprenorphine and naloxone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking buprenorphine or buprenorphine and naloxone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What special dietary instructions should I follow?

Talk to your doctor about drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

side effects this medication causes

Buprenorphine or buprenorphine and naloxone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• stomach pain
• constipation
• vomiting
• difficulty falling asleep or staying asleep
• sweating

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• hives
• skin rash
• itching
• difficulty breathing or swallowing
• slowed breathing
• upset stomach
• extreme tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms

Buprenorphine or buprenorphine and naloxone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

History

Buprenorphine was first marketed in the United States in 1985 as a schedule V narcotic analgesic.  Until recently, the only available buprenorphine product in the United States has been a low-dose (0.3 mg/ml) injectable formulation under the brand name, Buprenex�®.  Diversion, trafficking and abuse of other buprenorphine products have occurred in Europe and other areas of the world.
In October 2002, the Food and Drug Administration (FDA) approved two buprenorphine products (Suboxone�® and Subutex�®) for the treatment of narcotic addiction.  Both products are high dose (2 mg and 8 mg) sublingual (under the tongue) tablets: Subutex�® is a single entity buprenorphine product and Suboxone�® is a combination product with buprenorphine and naloxone in a 4:1 ratio, respectively.  After reviewing all the available data and receiving a schedule III recommendation from the Department of Health and Human Services (DHHS), the DEA placed buprenorphine and all products containing buprenorphine into schedule III in 2002.  Since 2003, diversion, trafficking and abuse of buprenorphine have become more common in the United States.

Licit Uses

Buprenorphine is intended for the treatment of pain (Buprenex�®) and opioid addiction (Suboxone�® and Subutex�®).  In 2001, 2005, and 2006, the Narcotic Addict Treatment Act was amended to allow qualified physicians, under certification of the DHHS, to prescribe schedule III-V narcotic drugs (FDA approved for the indication of narcotic treatment) for narcotic addiction, up to 30 patients per physician at any time, outside the context of clinic-based narcotic treatment programs (Pub. L. 106-310). This limit was increased to 100 patients per physician, for physicians who meet the specified criteria, under the Office of National Drug Control Policy Reauthorization Act (P.L. 69-469, ONDCPRA), which became effective on December 29, 2006.
Suboxone�® and Subutex�® are the only treatment drugs that meet the requirement of this exemption.  Currently, there are nearly 15,700 physicians who have been approved by the Substance Abuse and Mental Health Services Administration (SAMHSA) and the DEA for office-based narcotic buprenorphine treatment.  Of those physicians, approximately 13,150 were approved to treat up to 30 patients per provider and about 2,500 were approved to treat up to 100 patients.  More than 3,000 physicians have submitted their intention to treat up to 100 patients per provider.
IMS Health National Prescription Audit Plus data indicate that 3.54 million buprenorphine prescriptions were dispensed in the US in 2008, compared to 2.12 million prescriptions in 2007.

Chemistry/Pharmacology

Buprenorphine has a unique pharmacological profile. It produces the effects typical of both pure mu agonists (e.g., morphine) and partial agonists (e.g., pentazocine) depending on dose, pattern of use and population taking the drug. It is about  20-30 times more potent than morphine as an analgesic; and like morphine it produces dose-related euphoria, drug liking, papillary constriction, respiratory depression and sedation.  However, acute, high doses of buprenorphine have been shown to have a blunting effect on both physiological and psychological effects due to its partial opioid activity.

Buprenorphine is a long-acting (24-72 hours) opioid that produces less respiratory depression at high doses than other narcotic treatment drugs.  However, severe respiratory depression can occur when buprenorphine is combined with other central nervous system depressants, especially benzodiazepines.  Deaths have resulted from this combination.

The addition of naloxone in the Suboxone�® product is intended to block the euphoric high resulting from the injection of this drug by non-buprenorphine maintained narcotic abusers.

User Population

In countries where buprenorphine has gained popularity as a drug of abuse, it is sought by a wide variety of narcotic abusers: young naive individuals, non-addicted opioid abusers, heroin addicts and buprenorphine treatment clients.

Illicit Uses

Like other opioids commonly abused, buprenorphine is capable of producing significant euphoria.  Data from other countries indicate that buprenorphine has been abused by various routes of administration (sublingual, intranasal and injection) and has gained popularity as a heroin substitute and as a primary drug of abuse.  Large percentages of the drug abusing populations in some areas of France, Ireland, Scotland, India, Nepal, Bangladesh, Pakistan, and New Zealand have reported abusing buprenorphine by injection and in combination with a benzodiazepine.
According to the National Forensic Laboratory Information System (NFLIS), drug items/exhibits submitted and identified as buprenorphine in state and local laboratories increased from 229 in 2004 to 4,245 in 2008.  DEA laboratories identified 5 buprenorphine items/exhibits in 2004 and 49 in 2008.  Buprenorphine now ranks among the top 25 most frequently identified substances analyzed in federal, state, and local laboratories according to NFLIS.  According to the 2006 Drug Abuse Warning Network (New DAWN ED) survey, an estimated 4,440 emergency room visits were associated with buprenorphine misuse.

Control Status

Buprenorphine and all products containing buprenorphine are controlled in Schedule III of the Controlled Substances Act.

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