BACKGROUND OF THE INVENTION

1. Field of the Invention

[0001] The present invention relates generally to the detoxification and treatment processes for patients that suffer from opioid dependency, such as an addiction to opium, morphine, heroin, hydrocodone, oxycodone and the like and, in particular, to a method of treating such opioid addiction, especially in a group that has been designated as Recovery Resistant Opiate-Dependent Persons (RROP). This invention is an abstinence-based model, meaning that the goal of the final phase of the treatment program is to become opiate-free, both physically and psychologically. Further, much of the treatment time for the present method can occur as outpatient/home-based treatment.

2. Description of the Related Art

[0002] Presently, there is an increase in the population segment that suffers from some type of opioid addiction, such as those subjects that are addicted to heroin, morphine, codeine, oxycodone, etc. The typical medical outcome of progressive untreated opiate dependence is either death or incarceration of the dependent subject.

[0003] The mechanism of physical dependence on opiates most clearly involves the noradrenergic cells of the locus ceruleus. Opiates act as antagonists at the inhibitory μ receptors of these cells, thereby decreasing presynaptic norepinephrine release by the cells. Over time, this results in an up-regulation of postsynaptic norepinephrine receptors. Concurrently, morphine down-regulates the synthesis of beta-endorphin, which normally acts at the inhibitory μ receptors. When the opiate is withdrawn, the cell, no longer being inhibited, releases norepinephrine presynaptically. At the same time, the postsynaptic supersensitivity, which results from the increase in norepinephrine receptors, leads to an amplification of the response, and an adrenergic storm ensues.

[0004] In response to the understanding of the central role of the μ receptor in the mechanism of opiate addiction, several abstinence-oriented strategies have been developed to treat opiate addiction. One such abstinence-oriented strategy involves the regular, typically twice weekly, administration of naltrexone, a potent, orally-effective, long-lasting μ receptor (μ opiate receptor) blocking agent. In another abstinence-oriented treatment, the opiate- dependent individual is maintained on buprenorphine. Because it is a partial μ-receptor agonist, buprenorphine has some slight reinforcing properties, and its acceptability by the opiate-dependent individual is high, as is compliance. At the same time, because it has high

affinity for the μ-receptor, it blocks the effects of opiates and causes the opiate-dependent individual to stop seeking them.

[0005] There are various segments of this opiate-dependent population that require special attention and treatment. For example, the American Society of Addiction Medicine (ASAM), in the Principles of Addiction Medicine (Third Edition), has designated a portion of the opiate-dependent population as those extremely unlikely to successfully recover from opiate addiction. This population, designated as Recovery Resistant Opiate-Dependent Persons (RROP), while possibly successfully moving through the detoxification process, is found to be much more likely to return to opioid abuse after treatment. A RROP is generally thought of as an unrecoverable opiate dependent person and can come from problem populations, such as: young and new entrants into the opiate-dependent world; long time chronic users for whom no hope remains; and individuals who come into opiate-dependence through the abuse of chronic pain management systems.

[0006] These RROPs have been recognized by the American Medical Association as having a high degree of difficulty in permanently recovering from opiate abuse. Further, the ASAM has indicated, in Principles of Addiction Medicine (Third Edition), that the use of buprenorphine and naltrexone has not yet been demonstrated to promote an increase in the likelihood of long-term abstinence in these RROPs. Accordingly, the prior art pharmacological solutions offered, such as the use of combination tablets of buprenorphine and naloxone (Suboxone®), even those methods that utilize buprenorphine and naltrexone alone, have many drawbacks, such as intensified withdrawal symptoms and low success rates, as discussed in many prior art publications.

SUMMARY OF THE INVENTION

[0007] The present invention provides a method of treating opioid addiction that overcomes the deficiencies of the prior art. In another aspect, the present invention provides a method of treating opioid addiction that improves the success rate of the Recovery Resistant Opiate-Dependent (RROP) segment of the opiate-dependent population. Further, the present invention provides a method of treating opioid addiction that combines unique drug application and counseling techniques, which improve the success rate of all opiate- dependent patients, and specifically the RROP segment of the population. [0008] The present invention provides a method of treating an opiate-dependent patient, having the following steps: a) administering a specific dosing regimen of buprenorphine to a patient in a detoxification process for seven days; b) maintaining the patient in an opiate-free state for five to ten days; and c) administering a specific dosing regimen of naltrexone to the

patient. In one embodiment, the present invention further has the step of applying a specified and individualized counseling and support program to the patient. Further, the patient may be a member of the Recovery Resistant Opiate-Dependent Persons (RROP) population. The buprenorphine of the present method may be administered to the patient sublingually. Further, the patient should be experiencing physical opiate-withdrawal symptoms before the administration of buprenorphine. In one embodiment, in step a) of the present method, 2 mg of buprenorphine is administered on or about every four hours on the first day of the seven days, 2 mg of buprenorphine is administered on or about every six hours on the second day of the seven days, 2 mg of buprenorphine is administered on or about every eight hours on the third day of the seven days, 1 mg of buprenorphine is administered on or about every six hours of the fourth day of the seven days, 1 mg of buprenorphine is administered on or about every eight hours of the fifth day of the seven days, 1 mg of buprenorphine is administered on or about every twelve hours of the sixth day of the seven days, and 1 mg of buprenorphine is administered once on the seventh day of the seven days. In a further embodiment, in step b), the patient is maintained in the opiate-free state in a safe house environment. In step c), the naltrexone is administered orally to the patient. In a further embodiment, in step c), 1.0 to 12.5 mg of naltrexone is administered to the patient followed by the administration of 12.5 mg of naltrexone from about six to twelve hours thereafter on the first day of naltrexone administration, 12.5 mg of naltrexone is administered to the patient twice daily on the second day of naltrexone administration, 25 mg of naltrexone is administered to the patient twice daily on the third day of naltrexone administration, and 50 mg of naltrexone is administered once daily on a fourth, fifth, sixth, seventh, and eighth day of naltrexone administration. [0009] The present invention is also directed toward a method of treating an opiate- dependent patient, having the steps of: a) administering 1 mg to 12 mg of buprenorphine for seven days to a patient experiencing physical opiate- withdrawal symptoms; b) maintaining the patient in an opiate-free state for five to ten days; c) administering 1.0 to 50 mg of naltrexone to the patient for an unspecified period of time; and d) applying a specified and individualized counseling and support program to the patient at predetermined stages during the method.

[0010] Further, in another embodiment of the present invention a method of treating an opiate-dependent patient is provided, having the steps of: a) administering 2 mg of sublingual buprenorphine on or about every four hours on the first day of a seven day period to a patient experiencing physical opiate-withdrawal symptoms; b) administering 2 mg of sublingual buprenorphine to the patient on or about every six hours on the second day of the

seven day period; c) administering 2 mg of sublingual buprenorphine to the patient on or about every eight hours on the third day of the seven day period; d administering 1 mg of sublingual buprenorphine to the patient on or about every six hours on the fourth day of the seven day period; e) administering 1 mg of sublingual buprenorphine to the patient on or about every eight hours on the fifth day of the seven day period; f) administering 1 mg of sublingual buprenorphine to the patient on or about every twelve hours on the sixth day of the seven day period; g) administering 1 mg of sublingual buprenorphine to the patient once on the seventh day of the seven day period; h) subsequently maintaining the patient in an opiate- free state for five to ten days; i) subsequently administering 1.0 to 12.5 mg of oral naltrexone to the patient followed by the administration of 12.5 mg of naltrexone from about six to twelve hours thereafter on the first day of a naltrexone program; j) administering 12.5 mg of oral naltrexone to the patient twice daily on the second day of the naltrexone program; k) administering 25 mg of oral naltrexone to the patient twice daily on the third day of the naltrexone program; and 1) administering 50 mg of oral naltrexone to the patient once daily on the fourth, fifth, sixth, seventh, and eighth day of the naltrexone program. [0011] The present invention relates generally to a method of treating opioid addiction. The method of the present invention is particularly useful in connection with a specified segment of the opiate-dependent population designated as RROPs. A RROP is generally thought of as an unrecoverable opiate-dependent person and can come from problem populations, such as: young and new entrants into the opiate-dependent world; long time chronic users for whom no hope remains; and individuals who come into opiate-dependence through the abuse of chronic pain management systems. The method of the present invention has demonstrated novel and unique benefits and success in facilitating full detoxification, recovery and retention in opiate-free state in this RROP segment. Further, by using the method and system of the present invention, a significant quantity of patients have successfully transitioned from the detoxification process to an abstinent and opiate-free life. The presently-invented method was developed from a long-term series of trials and studies, which have refined a strategy, dosing and counseling and support techniques, which are uniquely tailored to each patient. Using these tailored strategies, dosing and counseling techniques, the present invention has demonstrated a high percentage of success in the treatment of RROPs.

[0012] As discussed herein and above, the method of the present invention includes the steps of: (a) administering a specific dosing regimen of buprenorphine to a patient in a detoxification process; (b) isolating the patient for a predetermined amount of time in a "step-

off period; (c) administering a specific dosing regimen of naltrexone to a patient in order to effectively block certain neurological receptors of the patient from the effects of the opiate; and, optionally, (d) throughout the method, apply a specified and individualized counseling and support program in a multi-level, multi-professional process.

[0013] These and other features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims, all of which form a part of this specification. As used in the specification and the claims, the singular form of "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

DETAILED DESCRIPTION OF THE INVENTION

[0014] It is to be understood that the invention may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. [0015] The present invention is a method of treating an opiate-dependent individual, such as an individual who is part of the RROP segment of the opiate-dependent population. An "opioid" is any agent that binds to opioid receptors found principally in the central nervous system and gastrointestinal tract. There are four broad classes of opioids: endogenous opioid peptides, produced in the body; opium alkaloids, such as ^' morphine (the prototypical opioid) and codeine; semi-synthetic opioids such as heroin and oxycodone; and fully synthetic opioids such as pethidine and methadone that have structures unrelated to the opium alkaloids. As used herein, the term "opiate" is used interchangeably and synonymously with "opioid". "Opiate-dependence" means a physical, physiological or psychological reaction and/or interaction of the opiate drugs and person, which results in the person exhibiting or having a forced or compulsive use of the drug without a recognized purpose or need for treating a disease, but rather for the purpose of achieving the desired effect, and/or to avoid withdrawal symptoms as defined hereinafter, which occur when the drug is discontinued or the amount used is reduced. "Opiate-free" means a duration of time wherein a patient does not use an opiate drug.

[0016] The method of the present invention includes the steps of: (a) administering a specific dosing regimen of buprenorphine to a patient in a detoxification process; (b) administering a specific dosing regimen of naltrexone to a patient in order to effectively block certain neurological receptors (μ opiate receptors) of the patient from the effects of the

opiate; and (c) throughout the method, apply a specified and individualized counseling program, which can be provided in a multi-level, multi-professional process. A "step-off" period is also part of the method of the present invention. The "step-off period is a duration of time where a patient is not receiving buprenorphine, nor are they receiving any opiates into their body. Preferably, the "step-off period occurs in a "safe house" or a "safe house-like" environment. A "safe house" is generally defined as a shelter for a patient where a patient is restricted from accessing opiate substances so the patient will not be tempted to succumb to their drug urges. A "safe house" could be a hospital, a mental institution, a rehabilitation facility, or the like. A "safe house-like" environment is an environment that is directed at eliminating the presence or the entry of any opiate substances and environmental triggers that may entice the patient into taking opiates, such as a remote cabin setting or the like. [0017] It has been recognized that at least 90% of the opiate-dependant population that begins the detoxification process completes this detoxification process. However, prior to the Food and Drug Administration's approval of buprenorphine, the quantity of opiate-dependant patients attempting detoxification was quite low, and the quantity of those that remained opiate- free after this detoxification process was even lower. Without the use of the presently- invented method, and according to the prior art, less than 10% of the population remained opiate-free long enough to have an opportunity to even use naltrexone. During the initial trials underlying the present invention, it was discovered that, of the detoxified patients, less than 20% remained opiate-free long enough to allow the naltrexone to be administered. [0018] During the initial trials underlying the present invention, it was also discovered that, of the successfully detoxified patients, less than 10% remained opiate-free long enough to allow the naltrexone to be administered. For medical safety reasons, all patients must be free of all opiates for about 5 to 10 days prior to the administration of naltrexone. However, according to the present invention, it was discovered that when a patient received continual support and counseling from a qualified team, as well as from a designated support group, approximately 30% of patients remained opiate- free for a long enough period, such as 7 days, and subsequently entered the naltrexone administration regimen. Accordingly, the present invention evidences an approximately 300% improvement in naltrexone start rates over the prior art. Such trials indicate that the retention levels are increased when the full method according to the present invention is utilized, which includes the proper education of the support group. Such data is reflective of the performance of patients using the presently- invented method on an outpatient basis.

[0019] As part of the process of the present invention, the patient is isolated for a predetermined amount of time in a "step-off period, typically in a safe house. It is believed that such a safe house will increase the number of patients who can complete the approximately five to ten day period when they must remain opiate-free, prior to the initiation of the naltrexone regimen. Such an isolation or safe house procedure will capture the outstanding 60%-70% of the detoxified opiate users who are currently failing to reach the naltrexone step.

[0020] In addition, the presently-invented method is considered an "abstinence-based" program, as opposed to a "maintenance-based" program. Presently, buprenorphine hydrochloride is combined with naloxone hydrochloride in tablets under the brand name "Suboxone®". This resulting combination is considered a low-dose opiate, and the program currently offered with Suboxone® is a maintenance-based program, which is offered in lieu of the typical methadone treatment. However, the present invention is an abstinence-based model, meaning that it uses naltrexone at a step in the process that is completely opiate-free. Further, much of the treatment time for the present method can occur as outpatient/home- based treatment.

[0021] As a result of the initial trials and case studies, it has been determined that the dosage of buprenorphine administered to the patient is important during the detoxification process, hi particular, the present invention typically uses 1 to 2 mg doses of sublingual buprenorphine hydrochloride tablets during the withdrawal process. However, higher or lower doses of buprenorphine may be used, such as from about 0.05 to 10.0 mg doses of buprenorphine. The frequency of the doses generally tapers over the days of administration. For instance, on the first day of treatment, buprenorphine may be administered from every one to eight hours, followed by from every eight to twenty-four hours on the second day, etc. The patient must be experiencing physical withdrawal from opiates before buprenorphine is administered. An experience of physical withdrawal generally consists of signs and symptoms opposite to those of the drug when initially administered: such as, severe dysphoria, anxiety, eye tearing, a runny nose, goose bumps, cramps and deep pains. Sublingual buprenorphine hydrochloride tablets, such as Subutex®, are preferably used in the method of the present invention. In patients that are deemed to be heavier intravenous opiate users, it may be preferable to use Suboxone® during the detoxification process. However, other immediate-release and extended-release dosage forms of buprenorphine, now known or heretofore developed, may also be used, such as, but not limited to intravenous formulations, transdermal preparations, intramuscular formulations, and

suppositories. The tapered process of the present method allows minimization of the pain and discomfort experienced by the patient during detoxification. The present invention further uses a naltrexone-administering process to block or significantly reduce by approximately 75% to 90% the psychological cravings for opiates. In addition, the naltrexone process is only applied to the patient after the detoxification process is complete. A patient must be opiate-free for a period of about five to ten days before naltrexone is administered. This opiate-free period is preferably endured by a patient under the support of a safe house environment. However, if a patient does not stay in a safe house or safe house- like environment during this opiate-free period, then a low dose of naltrexone, as a test dose, is administered on at least one of the five to ten days to determine whether the patient is indeed opiate- free. Also, a test dose of naltrexone may be given even if a patient does stay in a safe house or safe house-like environment during this period. In one particular embodiment of the present invention, a test dose of 3 mg of liquid naltrexone is given orally in the morning on the first day that the naltrexone is to begin to ensure that the patient is opiate- free. Preferably the test dose is given to the patient by a professional member of the support team. If the patient does not experience signs or symptoms of opiate-withdrawal within thirty minutes to a few hours of receiving the test dose, then the patient may continue with the naltrexone phase of the present method. Alternatively, the patient may be given 1/8 (6.25 mg) of a 50 mg naltrexone tablet to ingest as the test dose. This alternative is particularly useful if the patient is unable to be attended to by a professional member of their support team, such as, if the patient is incarcerated, if the patient is at a far away destination from a professional member of their support team, if they encounter problems driving to their appointment to receive a test dose, etc. Again, only if the patient is opiate-free and not experiencing any symptoms of opiate-withdrawal, then the patient may undergo the naltrexone process of the present invention. The present invention typically uses 12.5 to 50 mg doses of naltrexone during the withdrawal process. However, higher or lower doses of naltrexone may be used, such as from about 3.0 to 250.0 mg of naltrexone. As stated above, the test dose of naltrexone is typically from 3.0 to 6.25 mg of naltrexone, however, higher or lower test dose amounts may be administered, such as from about 1.0 to 12.5 mg of naltrexone. The frequency of the naltrexone doses generally tapers over the days of administration, however the strength of the doses generally increase. For instance, on the first day of treatment, naltrexone may be administered from every one to twelve hours at a dose of from 1.0 to 50 mg, followed by from every two to twenty- four hours on the second day at a dose of from about 5.0 to 250 mg, etc. Oral naltrexone hydrochloride tablets, such as

Revia®, are preferably used in the method of the present invention. However, other immediate-release and extended-release dosage forms of naltrexone, now known or heretofore developed, may also be used, such as, but not limited to capsules, suspensions, emulsions, solutions, intravenous formulations, transdermal preparations, troches, suppositories and intramuscular formulations. Through a series of trials and case studies, the method of the present invention has been developed and demonstrates a successful detoxification process and long-term retention of the now opiate-free patient. [0022] In one particular embodiment of the present invention, the multi-step method of treatment is as follows: a) once the opiate-dependent patient experiences physical withdrawal signs and/or symptoms from opiate cessation, a seven-day front load detoxification with buprenorphine is commenced; b) next, the patient is maintained in an opiate-free state for approximately five to ten days in preferably a safe house or a safe house-like environment; and c) finally, a multiple-day treatment program step with naltrexone is commenced. Throughout the multi-step method the patient also receives support, counseling and guidance from their support team, hi one embodiment, the support, counseling and guidance is a multi-level, multi-professional process at predetermined stages. Multi-level means that the support, counseling and guidance given to the patient may be more frequent and intense or less frequent and intense at predetermined stages of the treatment program, such as at the beginning, during, or after the step of the buprenorphine detoxification, at the beginning, during, or after the "opiate-free" state, and/or at the beginning, during, or after the step of the naltrexone program. Multi-professional means that the support, counseling and guidance may be provided by a variety of members of the support team, such as, doctors, psychologists, nurses, counselors, etc. The support, counseling and guidance, however, may also be increased or decreased in duration and intensity according to the resistance or improvement of the patient. For instance, the counseling and guidance after the detoxification step may increase from a lessened state because the patient will generally be physically ill from the detoxification and not wish to be attended to as aggressively. [0023] In one embodiment, the seven-day front load setup with buprenorphine occurs according to the following schedule: Day One) 2 mg of buprenorphine in lozenge form is sublingually administered to the patient on or about every four hours; Day Two) 2 mg of buprenorphine in lozenge form is sublingually administered to the patient on or about every six hours; Day Three) 2 mg of buprenorphine in lozenge form is sublingually administered to the patient on or about every eight hours; Day Four) 1 mg of buprenorphine in lozenge form is sublingually administered to the patient on or about every six hours; Day Five) 1 mg of

buprenorphine in lozenge form is sublingually administered to the patient on or about every eight hours; Day Six) 1 mg of buprenorphine in lozenge form is sublingually administered to the patient on or about every twelve hours; Day Seven) 1 mg of buprenorphine in lozenge form is sublingually administered to the patient. It is important to note that the amount, frequency, and duration of buprenorphine therapy may be increased or decreased as needed to tailor to a particular patient. For instance, the front load step may last up to ten days, or the amount of buprenorphine may need to be doubled per dose, or the frequency time interval between doses may need to the shortened if a patient is not responding adequately. Further, a loading dose of buprenorphine at from about 2 mg to 10 mg may be given in conjunction with the first 2 mg dose of buprenorphine to patients deemed to be especially heavy users of opiates, such as using from about ten to fifteen stamp bags of heroin per day or more. [0024] In an embodiment of the present invention where a test dose of naltrexone is administered, the multiple-day treatment process with naltrexone occurs according to the following schedule: First) 3.0 mg or 6.25 mg of naltrexone is orally administered the first day (such as, in the morning hours); Second) If the patient is determined to be opiate-free, 12.5 mg of naltrexone is administered approximately six to twelve hours after the first dose (such as, in the evening of the first day); Third) 12.5 mg of naltrexone is orally administered two times on the second day, preferably at time intervals spaced six to twelve hours apart; Fourth) 25 mg of naltrexone is orally administered two times on the third day, preferably at time intervals spaced six to twelve hours apart; Finally) 50 mg of naltrexone is administered once a day for at least five days.

[002S] In an embodiment of the present invention where a test dose of naltrexone is not administered, the multiple-day treatment process with naltrexone occurs according to the following schedule: First) 12.5 mg of naltrexone is orally administered once daily for a two- day period; Second) 12.5 mg of naltrexone is orally administered two times a day for two days, preferably at time intervals spaced six to twelve hours apart a day; Third) 25 mg of naltrexone is orally administered two times a day for two days, preferably at time intervals spaced six to twelve hours apart a day; Finally) 50 mg of naltrexone is administered once a day for at least two days.

[0026] After either the naltrexone test dose embodiment or the naltrexone non-test dose embodiments discussed above, the patient is maintained on 50 mg of naltrexone once a day until it is determined by at least one professional member of the support team that they can cease the use of the medication. The cessation of naltrexone is determined on an individual basis and can be influenced by a variety of environmental and emotional factors. The

naltrexone process can continue for from about one year up through the life of the patient. Additionally, it is recommended that the dose of naltrexone be administered after the patient has eaten a meal or concurrently with the ingestion of food. Further, as with the buprenorphine step, the amount, frequency and duration of naltrexone therapy may be increased or decreased as needed to tailor to a specific patient.

[0027] In one embodiment, the method further includes the use of a naltrexone checklist. In particular, each patient provides information regarding his or her cravings, and this and other data collected assists in evaluating the overall success rate of the naltrexone- administering process with the opiate-dependant individual. Such information directly from the patient has led to the determination that naltrexone reduces the psychological cravings of the opiate-dependant individual. This reduction, in turn, increases the population of individuals who successfully remain absent from opiate use in the long term. The present invention enables opiate-dependent individuals, as well as individuals from the RROP segment, an opportunity to fully recover from opiate addiction and remain abstinent. The prior art methods have little opportunity to RROPs, and many RROPs were unknowingly left out of the recovery process. Many medical professionals believed and may still believe that this group of RROPs were and are not capable of successfully remaining abstinent after detoxification.

[0028] As discussed previously, RROPs consist of various population segments, including: young and new entrants into the opiate-dependant world; longtime chronic users for whom no hope remains; and individuals who come into opiate dependence through the abuse of chronic pain management systems. All three groups have been recognized as "problem groups." [0029] The present invention is a method that teaches the administration of buprenorphine and naltrexone to opiate-dependent subjects in a unique and novel manner, which gives rise to the successful results. The present invention has led to the demonstration that the independent use of naltrexone reduces psychological cravings for narcotics, which represents a unique use of naltrexone. By blocking these psychological cravings, the method of the present invention may be applied to an increased number of patients. In addition, by administering naltrexone in conjunction with the aforementioned support team, together with the patient's support group, such a combination serves to reduce and block psychological cravings for narcotics, which thereby increases the retention rates of RROPs beyond the 20%- 30% discussed in the prior art.

[0030] The method of the present invention employs a previously unrecognized use of naltrexone, a full μ opioid receptor antagonist, such as Revia®, which blocks the cravings of

the individual. Accordingly, when the overall method is employed in a stepwise manner, together with ongoing counseling, the retention rates increase dramatically, especially in the RROP population. Still further, when the "step-off period is utilized, such as by isolating the patient in a safe house, the retention rate increases even further, and more RROPs successfully complete this period during which they remain opiate- free. These results clearly demonstrate that the conclusions and previously-held beliefs of the ASAM were not fully accurate and based upon less complete or less sophisticated treatment models. [0031] The counseling and support process has proven to be crucial to the success of the method of the present invention. This counseling process is specified and individualized according to any specific individual, and this process is both multi-level as well as multi- professional in nature. Further, each patient receives at least one telephone call per day from each member of their support group team. The support group may consist of treating physicians, nurses, counselors, motivational counselors, therapists, case managers, etc. Further, the support group preferably consists of individuals who are significant in the patient's life. These significant individuals are educated on how to administer and control the patient's medication, how to motivate and encourage the patient, and how to eliminate triggers that may produce psychological cravings. All of these individuals combine to create an effective support team that significantly increases the retention of opiate-free individuals. In one embodiment, the presently-invented method is an outpatient method, which reduces the significant costs of prior art opiate maintenance and elimination programs. [0032] In summary, the present invention provides a method of effectively treating those with opiate addiction, and has proven effective with previously-designated Recovery Resistant Opiate-Dependent Persons. The combination of outpatient detoxification with buprenorphine and the subsequent administration of naltrexone, which reduces the psychological cravings of narcotics, increases the number of individuals remaining opiate- free. The use of a safe house or safe house-type environment during a specified period of detoxification, such as from about five to ten days, ensures that the patient will remain opiate- free. Accordingly, the safe house "step-off period provides an opiate-free environment where the patient can remain free from opiates prior to administration of naltrexone. The use of this "step-off period increases the retention level and success of the patient, and it also offers opiate recovery to a greater number of individuals in the opiate-dependence population. Reduction of opiate dependence with higher success in an area and group that was previously ignored, through pharmacological intervention, use of medical personnel,

drug therapists, motivational counselors, case managers, etc. are unique approaches of the presently-invented method.

[0033] The method of the present invention serves to reduce the psychological cravings for narcotics in individuals by 75%-90% through the administration of, for example, 50 mg of naltrexone. The number of RROP individuals remaining opiate-free after the detoxification process is significantly increased through the use of this method, and is further increased through the use of a support team, which has been properly educated. The support team or group may consist of individuals who are significant in the patient's life, such as friends, family and spouses, and this group must be educated to properly deal with the recovering patient. The support group is also taught how to administer and control medication, how to motivate and encourage the patient, and how to eliminate triggers that may produce psychological cravings.

[0034] The use of naltrexone in the present method is considered a unique use. In particular, naltrexone is used to suppress and block the patient's psychological cravings for narcotics. These psychological cravings are what have prevented many RROPs from remaining opiate- free in the past. By reducing these cravings, the number of RROPs that are retained opiate-free is significantly greater.

[0035] The present method successfully helps to retain some RROPs as opiate-free on an outpatient basis, specifically through the maintenance of daily contact with a patient and the treating physician, medical staff, drug and vocational counselors, motivational personnel, case managers, etc. As discussed previously, each patient may receive one or more telephone calls per day from each member of the team, which increases the individual's attention and enthusiasm to remain part of the process.

[0036] As discussed above, the use of a safe house or safe house-type environment also adds to the success rate of this method. At the patient's request or the physician's direction, the safe house is provided to the individual, which in turn provides the individual a place that is supervised by medical staff during the approximately five to ten day "step-off period, when the patient must remain opiate-free prior to administering the naltrexone. As discussed previously, if the patient elects to remain as an outpatient during this "step-off period, then a low dose of liquid naltrexone may be administered to determine whether the patient is opiate- free. If the patient is indeed opiate-free, then the naltrexone-administering period begins. Once the patient begins this naltrexone regimen, whether as an outpatient or post-safe house discharge, the support team continues to maintain the daily support and counseling. This

program, including dosages, regimens, isolation periods, counseling programs, counseling group identity, etc. is all individualized to each patient according to his or her needs. [0037] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.