Louisville Suboxone Clinic - Substance Use Withdrawal in the Iroquois Manor Shopping Center here in Louisville, Kentucky.
-Outpatient Buprenorphine Withdrawal Program was designed to help patients struggling with Opioid Addiction including Heroin, Percoset, Vicodin, Oxycodone, Morphine, Methadone, etc. The patient’s treatment and recovery process often begins with an Initial Phone or face to face Screening and may continue with a formal Intake, Kasper Report, 12 Panel Rapid Drug Screen that includes Suboxone, a Substance Use Evaluation, development of a Treatment Plan with the patient and a Physician Evaluation to determine if the patient may be an appropriate candidate for our Opiate Withdrawal or Opiate Maintenance Programs, needs other types of services or needs a referral to a more appropriate service.
Next, an appointment for a Suboxone Induction may be scheduled where the patient could be observed at our clinic upon initiating Suboxone medication. Following a successful Suboxone Induction, the patient generally enters into a Weekly, Bi-Weekly or Monthly Maintenance Program for from 4 to 12-weeks. The actual length and format for each patient’s treatment program is a collaborative decision between you as the patient and the treatment team made of the Patient, the Certified Physician, the Substance Use/Abuse Counselor, the Clinical Director and Other Clinical Team Members.
All Counseling Groups are multi-faceted, in order to provide psycho-educational presentations designed to assist you in understanding of:
1) Symptoms of the patient’s opiate addition,
2) Understanding of the role of individual, group, marriage, family, intervention counseling in recovery process from opiate addition,
3) Effects of the patient’s opiate addiction on the workplace,
4) Understanding of the effects of the patient’s opiate addiction on the family,
5) Understanding of the effects of the patient’s opiate addiction on physical/medical health,
6) Understanding of the effects of the patient’s opiate addiction on marriage, partnership, friends and associates,
7)Understanding of recovery process from opiate addiction.
8) Understanding of the role of individual, group, marriage, family, intervention counseling in recovery,
9) Understanding of the role of medication including Suboxone, Subutex, Subsolv and Naltroxone in you recovery.
10) Understanding of the role of self-help programs of alcoholics anonymous and narcotics anonymous programs in recovery,
11) Understanding of the role of a sponsor or mentor in recovery, 11) Understanding of the role of study groups in recovery,
12) Understanding of the role and importance of social, relational, leisure, recreation, hobbies in recovery,
13) Understanding of the role of maintaining continuous sobriety,
14) Understanding of the role of responsibility in recovery,
15) Understanding of the role of motivation in recovery,
16) Understanding of the role of outpatient counseling in recovery.
17) Understanding of the role and importance of random drug testing in recovery.
18) Understanding of the role of followup evaluation in recovery.
19) Understanding of the role of education aimed at increasing safe copings skills in prevention of return to active illicit or illegal opiate use.
All patients are required to attend a minimum Normal Minimal Treatment Plan of two 1 ½ hour Substance Counseling Groups and one 45 minute Individual Counseling facilitated by an addiction counselor in addition to Suboxone medication management appointment with one of our board certified addiction psychiatrists. Individual therapy is available and highly encouraged for all of the patients in the Suboxone practice. Following the completion of the weekly maintenance group, patients transfer into a monthly maintenance group for ongoing addiction education and support while receiving Suboxone maintenance therapy.
What is Suboxone?
Suboxone is a medication used to treat opioid addiction and can also help with pain control. Suboxone has two components; Buprenorphine and Naloxone. It should be noted that Suboxone can only be used when withdrawal symptoms are active; early administration of the drug can actually exacerbate symptoms and cause the patient to experience a setback in their addiction recovery.
What is Buprenorphine?
Buprenorphine is an opiate partial agonist, which means that it partially binds to the opioid receptor, but not to the same degree as other opioids. There are many opioids which have only agonist activity: heroin, Percocet, Vicodin, oxycodone, Oxycontin, morphine and methadone to name a few, etc. Having only agonist activity means that they bind completely to the receptor. Although other opioids bind completely to the opioid receptor, the brain prefers buprenorphine.
What is Naloxone?
Naloxone is an opioid antagonist which is not absorbed orally; so if taken under your tongue, it does not take effect.
What Services Do We Provide.... Above & Beyond Counseling Service provides availability to physicians and/or psychiatrist as needed along with a comprehensive array of high quality clinical services and referral for individuals seeking recovery from alcohol and other drug abuse or addiction, while providing supportive case management and counseling throughout the crucial early months of recovery from all substance addiction disorders.
Our team is unique in that it brings together experts from the field of medicine, psychiatry, and addiction, which gives us the ability to care for patients with both addiction and co-existing medical and/or psychiatric complications or illnesses enhances the quality of care for patients who also suffer from other medical conditions, other addictive disorders, or dual diagnosis for those patients struggling with both addictive and psychiatric disorders.
Our Outpatient Substance Abuse and Addiction Withdrawal Programs for: 1) Opioid Addiction, a Suboxone Withdrawal Program, 2) a Suboxone Maintenance Programs, 3) an Outpatient Cocaine Addiction Withdrawal Program, 4) an Outpatient Methamphetamine Addiction Withdrawal Program, 5) an Outpatient Marijuana Addiction Withdrawal Program, 5) an Alcohol Addiction Withdrawal Program and 6) other Addiction Programs as identified. Each Outpatient Withdrawal Program for various Addiction is designed to help patients struggling with opioid addiction to recover.
Treatment Services at Galang & Harmon, Outpatient Substance Withdrawal Solutions, include Day, Evening and Weekend Substance Use/Addiction Evaluation, Psychiatric Evaluation, Mental Health Evaluation, Educational Counseling, Group Counseling, Individual Counseling, Family Counseling, Intervention Counseling, and Case Management, and Dual-Diagnosis Counseling for patients to provide support throughout the crucial first months of recovery from substance addiction as well as orientation to available self-help programs in the community.
We have been serving Louisville and its surrounding 7 communities as well as the southern Indiana regions for over 25 years with a long tradition of encouraging strength, hope and courage as we treating individuals and their families with dignity, care, and respect while assisting them in facing the challenge of recovering from the effects of alcohol and/or other drug abuse and addictions.
Our Vision is to continue our long tradition of inspiring hope and providing dignified, respectful care to our patients, while incorporating the latest advances in addiction medicine in order to provide our patients will the fullest range and highest quality of treatments at the lowest financial cost.
Our Mission is to provide evidenced-based, compassionate care in a professional and collaborative manner which creates an atmosphere of hope that not only promotes recovery from alcohol or drug addiction but provides a space where patients can discover their highest human potential and be inspired to make recovery-oriented changes medically, socially, emotionally, and spiritually, to provide Patient Centered-Care that elicits the patient's strengths and supports the patient in a way that helps in making long lasting recovery-oriented changes, to provide Collaborative Care to achieve the best outcomes for our patients through collegial staff relationships and the delivery of care through a team oriented approach while including the patient as a vital part of the team, to provide an opportunity to dismantle the stigma associated with substance use disorders, to provide Professional Care by always maintaining professional attitudes of care that supports recovery-oriented change in our patients, supports our colleagues, supports continuing improvement of quality care, and takes advantage of opportunities for growth and learning as we provide the highest quality of evidence-based treatments and to provide Inspirational Care by creating hope in our substance use patient’s and our dually diagnosed patients by highlighting their strengths, encouraging improved confidence and discovery of their human potential. For Inpatient Detoxification referral and the Outpatient Suboxone Program for Opioid Addiction, please call (502) 896-8006 or (502) 377-7720.
Outpatient Suboxone Treatment
Suboxone is a drug approved by the Food and Drug Administration (FDA) in 2002 for the treatment of opioid addiction. It is very effective in decreasing or eliminating altogether the withdrawal symptoms associated with opioid addiction. This drug is taken sublingually (dissolved under the tongue). Taken properly it can reduce opioid use, help people stay in drug rehab treatment, and depress the symptoms of opioid withdrawal.
Suboxone is frequently used in outpatient drug treatment programs now. It is very effective and helps greatly to allow the patient to have a more comfortable opiate detoxification and maintenance program. All patients meet regularly with a physician who specializes in withdrawal. The physician determines the appropriate dose for each case. It is not usually necessary or preferable to spend any time in an inpatient setting, despite the critical period of opiate withdrawal. Most can be stabilized at home and detoxified at home while making scheduled visits to the outpatient facility for all counseling and physician services. The next two to six month continues with physician visits for medication management, group, and individual therapy on a slowly decreasing basis and recommend you stay active in our program for anywhere from a year to 18 months.
Each patient is different and this decision is usually discussed with your physician and counselor. We focus on education and relapse prevention planning that teaches patients the triggers that caused him to become addicted in the first place.
We are committed to using the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction as our guide in making practical and informed decisions about the treatment of opioid addiction with buprenorphine. This document provides step-by-step guidance through the opioid addiction treatment decision-making process. Using the materials provided in these guidelines, physicians should be able to (1) perform initial screening and assessment of patients with opioid addiction, (2) determine the appropriateness of buprenorphine treatment for patients with opioid addiction, (3) provide treatment of opioid addiction with buprenorphine according to established protocols, (4) assess for the presence of and arrange appropriate treatment services for co-morbid medical and psychosocial conditions and (5) determine when to seek specialty addiction treatment referral or consultation.
The history of opioid addiction treatment forms an important backdrop for the decisions that physicians will make regarding their use of buprenorphine. Developing informed decisions about care should take into account the state of the art of opioid addiction treatment and ancillary services that exist to support both the patient and physician.
A significant breakthrough in the treatment of opioid addiction occurred with the introduction of methadone in the 1960s. Methadone maintenance proved safe and effective and enabled patients to lead functional lives-something that was often not possible using only drug-free approaches. Within a few years of its introduction, however, new laws and regulations in the United States, including the Methadone Regulations in 1972 and the Narcotic Addict Treatment Act of 1974, effectively limited Methadone maintenance treatment to the context of the Opioid Treatment Program (OTP) (i.e., methadone clinic) setting. These laws and regulations established a closed distribution system.
Dave Harmon & Associates Inc. uses the Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction to make practical and informed decisions about the treatment of opioid addiction with buprenorphine. This document provides step-by-step guidance through the opioid addiction treatment decision-making process. Using the materials provided in these guidelines, Galang & Harmon has been able to (1) perform initial screening and assessment of patients with opioid addiction, (2) determine the appropriateness of buprenorphine treatment for patients with opioid addiction, (3) provide treatment of opioid addiction with buprenorphine according to established protocols, (4) assess for the presence of and arrange appropriate treatment services for co-morbid medical and psychosocial conditions, and (5)determine when to seek specialty addiction treatment referral or consultation. The Food and Drug Administration (FDA) approval of the longer acting opioid agonist levo-alpha-acetyl-methadol (LAAM) in the 1990s did little to change the situation. Efforts to return opioid addiction treatment to the mainstream of medical care began to take shape and gain momentum in the 1990s. In October 2000, the Children’s Health Act of 2000 (P.L. 106-310) was enacted into law. Title XXXV of the Act provides a “Waiver Authority for Physicians Who Dispense or Prescribe Certain Narcotic Drugs for Maintenance Treatment or Detoxification Treatment of Opioid-Dependent Patients.” This part of
the law is known as the Drug Addiction Treatment Act of 2000 (DATA 2000; Clark 2003). Under the provisions of DATA 2000, qualifying physicians may now obtain a waiver from the special registration requirements in the Narcotic Addict Treatment Act of 1974, and its enabling regulations, to treat opioid addiction with Schedule III, IV, and V opioid medications that have been specifically approved by FDA for that indication, and to prescribe and/or dispense these medications in treatment settings other than licensed OTPs, including in office-based settings. On October 8, 2002, two new sublingual formulations of the opioid partial agonist buprenorphine, Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone), became the first and, as of this writing, the only Schedule III, IV, or V medications to have received this FDA approval. To qualify for a DATA 2000 waiver, physicians must have completed at least 8 hours of approved training in the treatment of opioid addiction or have certain other qualifications defined in the legislation (e.g., clinical research experience with the treatment medication, certification in addiction medicine) and must attest that they can provide or refer patients to necessary, concurrent psychosocial services. The new guidelines provide information about the medical use of buprenorphine, based on (1) the evidence available from buprenorphine
studies and (2) clinical experience using buprenorphine in the treatment of opioid addiction. The guidelines are as complete as the expert members of the Consensus Panel on Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction could make them and should provide a reasonable basis for current best practices in the area. Physicians should note that the guidelines are not intended to fully address all possible issues that can arise in the treatment of patients who are addicted to opioids. Some issues cannot be substantively addressed in the guidelines because of the lack of controlled studies and the limited U.S. experience using buprenorphine in office-based settings. Physicians are urged to seek the advice of knowledgeable addiction specialists if their questions are not answered fully by the guidelines, and should keep themselves aware of training and information on the use of buprenorphine that becomes available after the publication of this document. Such information will be posted regularly on the
SAMHSA Buprenorphine Web site at http://www.buprenorphine.samhsa.gov.
Opioid Addiction Today in the United States Opioid Addiction Opioid addiction is a neurobehavioral syndrome characterized by the repeated, compulsive seeking or use of an opioid despite adverse social, psychological, and/or physical consequences. Addiction is often (but not always) accompanied by physical dependence, a withdrawal syndrome, and tolerance. Physical dependence is defined as a physiological state of adaptation to a substance, the absence of which produces symptoms and signs of 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. Tolerance is a state in which a drug produces a diminishing biological or behavioral response; in other words, higher doses are needed to produce the same effect that the user experienced initially. It is possible to be physically dependent on a drug without being addicted to it, and conversely, it is possible to be addicted without being physically dependent (Nelson et al.1982). An example of physical dependence on opioids without addiction is a patient with cancer who becomes tolerant of and physically dependent on opioids prescribed to control pain. Such a patient may experience withdrawal symptoms with discontinuation of the usual dose but will not experience social, psychological, or physical harm from using the drug and would not seek out the drug if it were no longer needed for analgesia (Jacox et al. 1994). An example of addiction to opioids without physical dependence is a patient addicted to oxycodone who has been recently detoxified from the drug. In this situation, the patient may no longer be suffering from withdrawal symptoms or tolerance but may continue to crave an opioid high and will invariably relapse to active opioid abuse without further treatment.
Factors contributing to the development of opioid addiction include the reinforcing properties and availability of opioids, family and peer influences, socio-cultural environment, personality, and existing psychiatric disorders. Genetic heritage appears to 4 influence susceptibility to alcohol addiction and, possibly, addiction to tobacco and other drugs as well (Goldstein 1994). Our Louisville Suboxone Clinic can help.
Addiction Rates. 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, oxycodone, meperidine, and propoxyphene, has risen markedly in recent years (Crane 2003). The incidence of emergency
department (ED) visits related to these medications has been increasing since the 1990s and has more than doubled between 1994 and 2001 (Crane 2003). In 2001, there were an estimated 90,232 ED visits related to opioid analgesic abuse, a 117 percent increase since 1994. Nationally,
were involved in 14 percent of all drug-abuse-related ED visits in 2001 (SAMHSA 2002b). According to the DAWN Mortality Data Report for 2002 (SAMHSA 2002c), hydrocodone ranked among the 10 most common drugs related to deaths in 18 cities, including Detroit (63), Las Vegas (46), Dallas (36), New Orleans (33), and Oklahoma City (31). 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). According to the Office of National Drug Control Policy (ONDCP), there were an estimated 810,000 to 1,000,000 individuals addicted to heroin in the United States in the year 2000-which is the highest number since the mid-to-late 1970s (ONDCP 2003). Several factors have contributed to this increase. Historically, heroin purity has been less than 10 percent. By the late 1990s, however, purity was between 50 and 80 percent. The increase in purity has made heroin easier to use by non-injection routes, such as snorting and smoking. Because individuals can become addicted to or overdose from heroin taken via any route, the increase in the type and number of routes used has led to a rise in new
cases of heroin addiction across all sociodemographic categories. Many addicted individuals may switch to the injection route as their heroin use continues to increase, or if heroin purity should decrease again. An increase in rates of injection drug use would have a significant effect on the
incidence of human immunodeficiency virus (HIV) infection, hepatitis B and C, and other infectious diseases. The rise of heroin use appears to be a nationwide phenomenon in the United States. Heroin overdose deaths have risen sharply, as have ED admissions involving heroin. The
most recent data on such ED admissions come from SAMHSA’s DAWN reports, which can be accessed via the Web at the following sites: http://dawninfo.samhsa.gov/ or http://www.nida.nih.gov/CEWG/DAWN.html.
Current State of Opioid Addiction Treatment
There are two main modalities for the treatment of opioid addiction: pharmacotherapy and psychosocial therapy. Pharmacotherapies now available for opioid addiction include (1) agonist maintenance with methadone; (2) partial-agonist maintenance with buprenorphine or buprenorphine plus naloxone; (3) antagonist maintenance using naltrexone; and (4) the use of antiwithdrawal (“detoxification”) agents (e.g., methadone, buprenorphine, and/or clonidine) for brief periods, and in tapering doses, to facilitate entry into drug-free or antagonist treatment. If you are typing in suboxone clinics in louisville Ky in your search box then you've come to the right place.
The rise of heroin use appears to be a nationwide phenomenon in the United States. (5) Psychosocial approaches (e.g., residential therapeutic communities), mutual-help programs (e.g., Narcotics Anonymous), and 12-Step- or abstinence-based treatment programs are important modalities in the treatment of addiction to heroin and other opioids, either as stand-alone interventions or in combination with pharmacotherapy. In 2003, more than 200,000 individuals in the United States were maintained on methadone or LAAM (SAMHSA 2002a). Although precise data are difficult to obtain, it is estimated that fewer than 5,000 individuals are maintained on naltrexone for opioid addiction. The number of individuals in 12-Step programs is
unknown because of the undisclosed nature of the programs and their assurance of anonymity. The number of patients in residential therapeutic community treatment who identify opioids as their primary drugs of abuse is conservatively estimated at 3,000–4,000.
Current Pharmacotherapy Treatment Options for Opioid Addiction:
Three traditional types of pharmacotherapy for opioid addiction are described briefly in this section: (1) agonist treatment (e.g., methadone pharmacotherapy), (2) antagonist treatment (e.g., naltrexone), and (3) the use of these and other agents (e.g., clonidine) to help withdrawal from opioid drugs as a means of entry into treatment. A discussion of the new treatment option using buprenorphine follows.
Methadone is the most commonly used medication for opioid addiction treatment in the United States. Well-run OTPs-with appropriate drug monitoring, counseling services (individual, group, family), and vocational resources and referrals -have been demonstrated to decrease heroin use and related crime, increase employment, improve physical and mental health (McLellan et al. 1993), and markedly reduce mortality (see the forthcoming TIP Medication-Assisted Treatment
for Opioid Addiction [CSAT in development†]), as well as the incidence of needle sharing (Metzger et al. 1991) and HIV transmission (Metzger et al. 1993). Methadone suppresses opioid withdrawal, blocks the effects of other opioids, and decreases craving for opioids.
Naltroxone is an opioid antagonist that blocks the effects of heroin and most other opioids. It does not have addictive properties or produce physical dependence, and tolerance does not develop. It has a long half-life, and its therapeutic effects can last up to 3 days. Naltroxone is not a stigmatized treatment. It also decreases the likelihood of alcohol relapse when used to treat alcohol dependence. From a purely pharmacological point of view, Naltroxone would appear to have the properties of a useful medication for the treatment of opioid addiction. Its usefulness in the treatment of opioid addiction, however, has been limited because of certain disadvantages. First, many addicted patients are not interested in taking Naltroxone because, unlike Methadone and LAAM, it has no opioid. Some TIPs are available online at http://www.kap.samhsa.gov/products/manuals/index.htm. Others can be ordered from the National Clearinghouse for Alcohol and Drug Information (NCADI) by accessing its electronic catalog http://store.health.org/catalog/ or by calling 1-800-729-6686. Up to five free hard copies may be ordered using the NCADI order number.
Agonist effects; patients continue to experience cravings and are thereby not motivated to maintain adherence to the medication regimen. Second, a patient addicted to opioids must be fully withdrawn for up to 2 weeks from all opioids before beginning Naltroxone treatment. Unfortunately, during this withdrawal period, many patients relapse to use of opioids and are unable to start on Naltrexone. Furthermore, once patients have started Naltrexone, it may increase the risk for overdose death if relapse does occur. Naltroxone has demonstrated some utility among subgroups of addicted patients with strong motivation and psychosocial support for treatment and medication adherence (e.g., healthcare professionals, business executives, younger patients, patients involved in the criminal justice system). Because most addicted patients will not voluntarily take Naltroxone, however, the number of individuals maintained on it continues to be low. Research is under way on a number of sustained-release, injectable forms of Naltroxone in an effort to increase adherence, particularly in the early stages of treatment.
Agents Used To Assist With Withdrawal From Opioid Drugs:
Medically supervised withdrawal (detoxification) from opioids is an initial component of certain treatment programs but, by itself, does not constitute treatment of addiction. A variety of agents and methods are available for medically supervised withdrawal from opioids. These include methadone dose-reduction, the use of Clonidine and other alpha-adrenergic agonists to suppress withdrawal signs and symptoms, and rapid detoxification procedures (e.g., with a combination of Naltroxone or Naltroxone and Clonidine and, more recently, buprenorphine).
Each of these methods has strengths and weaknesses. When used properly, various pharmacological agents can produce safe and less uncomfortable opioid withdrawal. As a result of the increasing purity of street heroin, however, physicians are reporting more difficulty managing patients with the use of Clonidine and other alpha-adrenergic agonists during withdrawal. Unfortunately, the majority of individuals addicted to opioids relapse to opioid use after withdrawal, regardless of the withdrawal method used. Too often, physicians and facilities use dose-reduction and withdrawal in isolation without adequate arrangements for the appropriate treatment and support services that decrease the likelihood of relapse and that are usually necessary for long-term recovery. (For more information about agents used to assist with withdrawal, see the forthcoming TIP Medication-Assisted Treatment for Opioid Addiction [CSAT in development].)
Buprenorphine: A New Treatment Option for Opioid Addiction Buprenorphine’s pharmacological and safety profile (see chapter 2) makes it an attractive treatment for patients addicted to opioids as well as for the medical professionals treating them. Buprenorphine is a partial agonist at the mu opioid receptor and an antagonist at the kappa receptor. It has very high affinity and low intrinsic activity at the mu receptor and will displace morphine, methadone, and other opioid full agonists from the receptor. Its partial agonist effects imbue buprenorphine with several clinically desirable pharmacological properties: lower abuse potential, lower level of physical dependence (less withdrawal discomfort), a ceiling effect at higher doses, and greater safety in overdose compared with opioid full agonists.
At analgesic doses, buprenorphine is 20-50 times more potent than morphine. Because of its low intrinsic activity at the mu receptor, however, at increasing doses, unlike a full opioid agonist, the agonist effects of buprenorphine reach a maximum and do not continue to increase linearly with increasing doses of the drug-the ceiling effect. One consequence of the ceiling effect is that an overdose of buprenorphine is less likely to cause fatal respiratory depression than is an overdose of a full mu opioid agonist. In the pharmacotherapy of opioid addiction, buprenorphine, as a partial opioid agonist, can be thought of as occupying a midpoint between opioid full agonists (e.g., methadone, LAAM) and opioid antagonists (e.g., Naltrexone, Nalmefene). It has sufficient agonist properties such that individuals addicted to opioids perceive a reinforcing subjective effect from the medication, often described in terms of “feeling normal.”
In higher doses and under certain circumstances, its antagonist properties can cause the precipitation of acute withdrawal if administered to an individual who is physically dependent on opioids and maintained on a sufficient dose of a full agonist. In this scenario, buprenorphine can displace the full agonist from the mu receptors, yet not provide the equivalent degree of receptor activation, thereby leading to a net decrease in agonist effect and the onset of withdrawal. (See chapter 2 for more details on such effects.) Furthermore, because of the high affinity of buprenorphine for the opioid receptor, this precipitated abstinence syndrome may be difficult to reverse. Buprenorphine produces a blockade to subsequently administered opioid agonists in a dose-responsive manner. This effect makes the drug particularly appealing to well-motivated patients, as it provides an additional disincentive to continued opioid use. Buprenorphine can produce euphoria, especially if it is injected. Buprenorphine does produce physical dependence, although it appears to do so to a lesser degree than do full opioid agonists, and it appears to be easier to discontinue at the end of medication treatment.
Buprenorphine has several pharmaceutical uses. It is a potent analgesic, available in many countries as a 0.3-0.4 mg sublingual tablet (Temgesic). Until 2002, the only form of buprenorphine approved and marketed in the United States was the parenteral form for treatment of pain (Buprenex). In 2002, two sublingual tablet formulations of buprenorphine were approved by FDA as opioid addiction treatment medications: buprenorphine alone (Subutex) and a combination tablet containing buprenorphine plus naloxone in a 4:1 ratio (Suboxone). Both of these tablets are Schedule III opioids and therefore eligible for use in the treatment of opioid addiction under DATA 2000. Figure 1-1 shows the dosage forms of buprenorphine currently available in the United States.
Note that, as of the date of this publication, Subutex and Suboxone are the only forms of buprenorphine that are indicated and can be legally used for the treatment of opioid addiction in the United States-neither Buprenex nor its generic equivalent can be used legally to treat opioid addiction. Many of the large clinical studies of buprenorphine in the treatment of opioid addiction in the United States have been conducted under the joint sponsorship of the National Institute on Drug Abuse (NIDA) and Reckitt Benckiser, the company holding the buprenorphine patent. The most extensive clinical experience with buprenorphine used for treatment of opioid addiction is in France, where the medication has been available for office-based treatment of opioid addiction since February 1996.
In France, buprenorphine can be prescribed for maintenance treatment by both addiction specialists and general practitioners. It is estimated that close to 70,000 patients are currently receiving maintenance treatment with buprenorphine in France. Buprenorphine doses studied for opioid addiction treatment have ranged from 1-2 mg to 16-32 mg, depending upon the formulation (solution versus tablet), with duration of treatment lasting from a few weeks to years. Using the outcome measures of illicit opioid use, retention in treatment, and assessment for adverse events, studies have shown that buprenorphine treatment reduces opioid use, retains patients in treatment, has few side effects, and is acceptable to most patients (Johnson 1992; Johnson 2000; Ling 1996; Ling 1998; O’Connor 2000). Although buprenorphine has been abused and injected by individuals addicted to opioids in countries where the sublingual tablet is available as an analgesic, its abuse potential appears substantially less than that of full opioid agonists. To reduce the potential for abuse even further, the sublingual tablet dosage form combining buprenorphine with naloxone was developed by NIDA and Reckitt Benckiser. The buprenorphine/naloxone combination tablet appears to have reduced abuse potential compared with buprenorphine alone when studied in opioid-dependent populations.
It works on the principle that naloxone is approximately 10-20 times more potent by injection than by the sublingual route. Therefore, if the combination is taken sublingually, Figure 1–1 Dosage Forms of Buprenorphine Available in the United States (as of July 2004).
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