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About Buprenorphine Treatment and Therapy
In October 2002, the Food and Drug Administration (FDA) approved buprenorphine monotherapy product, Subutex®, and a buprenorphine/naloxone combination product, Suboxone®, for use in opiate addiction treatment, including oxycontin treatment. The combination product is designed to decrease the potential for abuse by injection. Subutex® and Suboxone® are currently the only Schedule III, IV, or V medications to have received FDA approval for this indication. Note that aside from Subutex® and Suboxone®, other forms of buprenorphine (e.g., Buprenex®) are not approved for treatment of opiate addiction.
Applied Pharmacology
Buprenorphine is an opioid partial agonist. This means that, although buprenorphine is an opioid, and thus can produce typical opioid agonist effects and side effects such as euphoria and respiratory depression, its maximal effects are less than those of full agonists like heroin and methadone. At low doses buprenorphine produces sufficient agonist effect to enable an individual with an opiate addiction to discontinue the misuse of opioids without experiencing withdrawal symptoms. The agonist effects of buprenorphine increase linearly with increasing doses of the drug until at moderate doses they reach a plateau and no longer continue to increase with further increases in dose—the “ceiling effect.” Thus, buprenorphine carries a lower risk of abuse, addiction, and side effects compared to full opioid agonists. In fact, in high doses and under certain circumstances, buprenorphine can actually block the effects of full opioid agonists and can precipitate withdrawal symptoms if administered to an individual with an opiate addiction while a full agonist is in the bloodstream.
Buprenorphine has poor oral bioavailability and moderate sublingual bioavailability. Formulations for opiate addiction treatment are in the form of sublingual tablets.
Buprenorphine is highly bound to plasma proteins. It is metabolized by the liver via the cytochrome P4503A4 enzyme system into norbuprenorphine and other metabolites. The half-life of buprenorphine is 24–60 hours.
Safety
Because of its ceiling effect and poor bioavailability, buprenorphine is safer in overdose than opioid full agonists. The maximal effects of buprenorphine appear to occur in the 16–32 mg dose range for sublingual tablets. Higher doses are unlikely to produce greater effects.
Respiratory depression from buprenorphine (or buprenorphine/naloxone) overdose is less likely than from other opioids. There is no evidence of organ damage with chronic use of buprenorphine, although increases in liver enzymes are sometimes seen. Likewise, there is no evidence of significant disruption of cognitive or psychomotor performance with buprenorphine maintenance dosing.
Information about the use of buprenorphine in pregnant women with an opiate addiction is limited; the few available case reports have not demonstrated any significant problems due to buprenorphine use during pregnancy. Suboxone® and Subutex® are classified by the FDA as Pregnancy Category C medications.
Side Effects
Side effects of buprenorphine are similar to those of other opioids and include nausea, vomiting, and constipation. Buprenorphine and buprenorphine/naloxone can precipitate the opioid withdrawal syndrome. Additionally, the withdrawal syndrome can be precipitated in individuals maintained on buprenorphine. Signs and symptoms of opioid withdrawal include:
Because of its opioid agonist effects, buprenorphine is abusable, particularly by individuals who are not physically addicted to opioids. Naloxone is added to buprenorphine to decrease the likelihood of diversion and abuse of the combination product. Sublingual buprenorphine has moderate bioavailability, while sublingual naloxone has poor bioavailability. Thus, when the buprenorphine/naloxone tablet is taken in sublingual form, the buprenorphine opioid agonist effect predominates, and the naloxone does not precipitate opioid withdrawal in the opioid-addicted user.
Naloxone via the parenteral route, however, has good bioavailability. If the sublingual buprenorphine/naloxone tablets are crushed and injected by an opioid-addicted individual, the naloxone effect predominates and can precipitate the opioid withdrawal syndrome.
Under certain circumstances buprenorphine by itself can also precipitate withdrawal in opioid-addicted individuals. This is more likely to occur with higher levels of physical addiction, with short time intervals (e.g., less than 2 hours) between a dose of opioid agonist (e.g., methadone) and a dose of buprenorphine, and with higher doses of buprenorphine.
Evidence of Effectiveness
Studies have shown that buprenorphine is more effective than placebo and is equally as effective as moderate doses of methadone and LAAM in opioid maintenance therapy. Buprenorphine is unlikely to be as effective as more optimal-dose methadone, and therefore may not be the treatment of choice for patients with higher levels of physical dependence.
Few studies have been reported on the efficacy of buprenorphine for completely withdrawing patients from opioids. In general, the results of studies of medically assisted withdrawal using opioids (e.g., methadone) have shown poor outcomes. Buprenorphine, however, is known to cause a milder withdrawal syndrome compared to methadone and for this reason may be the better choice if opioid withdrawal therapy is elected.
Opioid Addiction Therapy with Buprenorphine
This section provides a brief overview of the clinical use of buprenorphine (Suboxone® and Subutex®) for opioid addiction therapy.
Ideal candidates for opioid addiction treatment with buprenorphine are individuals who have been objectively diagnosed with opioid addiction, are willing to follow safety precautions for treatment, can be expected to comply with the treatment, have no contraindications to buprenorphine therapy, and who agree to buprenorphine treatment after a review of treatment options. There are three phases of buprenorphine maintenance therapy: induction, stabilization, and maintenance.
The induction phase is the medically monitored startup of buprenorphine therapy. Buprenorphine for induction therapy is administered when an opioid-addicted individual has abstained from using opioids for 12–24 hours and is in the early stages of opioid withdrawal. If the patient is not in the early stages of withdrawal (i.e., if he or she has other opioids in the bloodstream), then the buprenorphine dose could precipitate acute withdrawal.
Induction is typically initiated as observed therapy in the physician’s office and may be carried out using either Suboxone® or Subutex®, dependent upon the physician’s judgment. As noted above, Buprenex®, the parenteral analgesic form of buprenorphine, is not FDA-approved for use in opioid addiction treatment.
The stabilization phase has begun when a patient has discontinued or greatly reduced the use of his or her drug of abuse, no longer has cravings, and is experiencing few or no side effects. The buprenorphine dose may need to be adjusted during the stabilization phase. Because of the long half-life of buprenorphine it is sometimes possible to switch patients to alternate-day dosing once stabilization has been achieved.
The maintenance phase is reached when the patient is doing well on a steady dose of buprenorphine (or buprenorphine/naloxone). The length of time of the maintenance phase is individualized for each patient and may be indefinite. The alternative to going into (or continuing) a maintenance phase, once stabilization has been achieved, is medically supervised withdrawal. This takes the place of what was formerly called “detoxification.”
Complete Drug Addiction Therapy with Buprenorphine
Effective treatment of drug addiction requires comprehensive attention to all of an individual’s medical and psychosocial co-morbidities. Pharmacological therapy alone rarely achieves long-term success. Thus Suboxone® and Subutex® treatment should be combined with concurrent behavioral therapies and with the provision of needed social services. This point is of such importance that physicians must attest to their capacity to refer patients for counseling when they submit their Notification of Intent to SAMHSA to begin prescribing Suboxone® and Subutex®.
For more detailed information on Subutex and Suboxone, please see the following: Subutex and Suboxone Q&A
At The Pat Moore Foundation Buprenorphine treatment and detox occur in a safe, comfortable, home-like environment that is a crucial element for the client’s state of mind. During this process they are still able to participate in counseling sessions with their case manager and group therapy with their peers, contingent on their physical well-being. To learn more about treatment, pricing and outpatient services, please click on the appropriate word.
If the individuals require further medical attention, Costa Mesa and the Newport Beach area have renowned hospitals within a few minutes of this facility.
If you have questions about whether you or a loved one may require detox please call our call us 24 hours a day at (888) 426-6086.
Many issues come up in early sobriety that can be difficult to handle. The staff at Pat Moore Foundation is on call 24-hours and understands this, and is eager to help at any time of the day or night. Our goal is to enable each person who enters our doors walk the road to a healthy and happy recovery.
Pat Moore Foundation's drug & alcohol detox and alcohol & drug addiction treatment programs are licensed and certified by The State of California. We provide non-medical and medically managed detoxification (using Suboxone, Subutex, and Buprenorphine when appropriate) and primary residential treatment. Our individual homes are on a unique co-ed campus where we offer gender specific treatment. We are located in Costa Mesa, in Orange County, Southern California, close to Newport Beach and Huntington Beach, and only an hour's drive from Los Angeles and San Diego. To speak with a counselor, please call us 24-hours at (888) 426-6086 or if you'd like us to contact you, send a confidential message online by filling out our online form.
Note: All medical services are administered by medical professionals, which are facilitated and operated solely under the jurisdiction of a separate medical corporation.
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Source: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, see http://buprenorphine.samhsa.gov/about.html.
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