| Detoxification from drugs and alcohol is the first step in
the treatment process toward recovery from drug addiction and alcoholism.
Expert medical and clinical staff, a safe, supportive environment,
and an introduction to the principles of recovery are the keys
to a successful and comfortable detox.
Social Model Detoxification
Safe, medically supervised Detoxification takes place at Support
Systems Homes Residential Treatment Facilities in the Bay Area. Our
detox program works closely with our other services to maintain the
highest standards of quality and treatment. Detoxification is designed
to support clients during withdrawal from alcohol and other drugs
and usually lasts from 3-7 days. Detox clients are monitored by qualified,
experienced staff 24 hours a day. Our staff physician completes a
detailed medical history and health examination for each client,
and prescribes any necessary detox medications. During the detoxification
period, we make every effort to engage the client in appropriate
treatment and make their withdrawal from alcohol and drugs as comfortable
as possible.
Goal
The ultimate goal of Support Systems Homes’ programs
is clients achieving long-term recovery and reintegration into society.
Objectives
The two major objectives of the Detoxification
Program are:
1. To safely and humanely detoxify the client from mood-altering
substances
2. To begin preparing the client for the appropriate level of care for substance
abuse treatment
We meet these goals by:
- Providing 24-hour supervision by qualified staff
- Providing
ongoing monitoring of client needs
- Providing in-depth health screening
and medical care
- Administering appropriate
detox medications as directed by our staff physician
- Rigorously
protecting client rights
- Providing a safe, supportive, comfortable
atmosphere
- Offering information and
education about alcohol and other drugs
- Introducing the client to recovery
principles and local self-help groups
- Providing referrals and educational
materials to meet the needs of our culturally diverse population
- Ensuring
quality through the continuous evaluation and improvement of
services.
Opiate Detox
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Buprenorphine therapy enables us to offer a detoxification
protocol for heroin addiction, methadone, oxycontin (oxycodone),
vicodin
(hydrocodone)
and other similar narcotics which minimizes the discomfort normally
associated with detoxing from these highly addictive substances.
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Support Systems is leading the pack with our
cutting edge opiate detoxification programs utiilizing buprenorphine
(subutex®, suboxone®)
to manage opiate withdrawl symptoms. Buprenorphine is a synthetic
opiate agonist medication that has recently been approved by the
FDA for treatment of opiate addiction. It enables us to offer a detoxification
protocol for heroin addiction, methadone, oxycontin (oxycodone),
vicodin (hydrocodone) and other similar narcotics which minimizes
the discomfort normally associated with detoxing from these highly
addictive substances. About Buprenorphine Therapy
Buprenorphine, a derivative
of thebaine, is an opiate that has been marketed in the United
States as the Schedule V parenteral analgesic
Buprenex®. In 2002, based on a re-evaluation of available evidence
regarding the potential for abuse, diversion, dependence, and side
effects, the DEA reclassified buprenorphine from a Schedule V to
a Schedule III narcotic. In October 2002, Reckitt Benckiser received FDA
approval to market a buprenorphine monotherapy product, Subutex®, and a buprenorphine/naloxone
combination product, Suboxone®, for use in opioid addiction treatment.
The combination product is designed to decrease the potential for
abuse by injection. Subutex® and Suboxone® are currently
the only medications to have received FDA approval for this indication.
In January 2003, Reckitt Benckiser began shipments of Suboxone® to
pharmacies in the United States.
The approval of these formulations does not affect
the treatment standards of previously approved medication-assisted
treatments,
such as methadone and LAAM (levo-alpha-acetyl-methadol). As indicated
in Title 42 Code of Federal Regulations Part 8 (42 CFR Part 8), these
therapies can only be dispensed, and only in the context of an Opioid
Treatment Program. Also, neither the approval of Subutex® and
Suboxone®, nor the provisions of DATA 2000, affect the use of
other Schedule III, IV, or V medications, such as morphine, that
are not approved for the treatment of addiction. Lastly, note that
other forms of buprenorphine besides Subutex® and Suboxone®,
e.g., Buprenex®, are not approved for treatment of opioid addiction.
Formulations
Suboxone®, a sublingual tablet, comes
in two dosage forms: 2 mg buprenorphine/0.5 mg naloxone and 8 mg
buprenorphine/2 mg naloxone.
Subutex®, also a sublingual tablet, is available in 2 mg and
8 mg strengths. The Subutex® and Suboxone® drug labels are
available on the FDA Web site at: http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm
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 opioid-addicted individuals
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 so-called “ceiling effect.” Thus,
buprenorphine carries a lower risk of abuse, dependence, 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 in an acutely opioid-intoxicated individual. Buprenorphine has poor oral bioavailability and moderate sublingual
bioavailability. Thus, formulations for opioid dependence 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, opioid-dependent women 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.
See the Buprenorphine Clinical Practice Guidelines (available soon
on this Web site) for more information about the use of buprenorphine
in pregnancy. Currently, methadone remains the standard of care for
the medication-assisted treatment of opioid-dependent women in the
United States.
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:
- Dysphoric mood
- Nausea or vomiting
- Muscle aches/cramps
- Lacrimation
- Rhinorrhea
- Pupillary dilation
- Sweating
- Piloerection
- Diarrhea
- Yawning
- Mild fever
- Insomnia
- Craving
- Distress/irritability
Drug Interactions, Cautions and Contraindications
Refer to the
Subutex® and Suboxone® package inserts (http://www.fda.gov/cder/drug/infopage/subutex_suboxone/default.htm)
for a complete listing of drug interactions, contraindications, warnings,
and precautions.
Abuse Potential
Because of its opioid agonist effects, buprenorphine
is abusable, particularly by individuals who are not physically dependent
on
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-dependent user. Naloxone via the parenteral route, however, has good bioavailability.
If the sublingual buprenorphine/naloxone tablets are crushed and
injected by an opioid-dependent individual, the naloxone effect predominates
and can acutely precipitate the opioid withdrawal syndrome.
Under certain circumstances buprenorphine by itself can also precipitate
withdrawal in opioid-dependent individuals. This is more likely to
occur with higher levels of physical dependence, 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.
Non-pharmacological Therapies
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 begin prescribing
Suboxone® and Subutex® to SAMHSA. The choice of treatment setting in which to provide
non-pharmacological therapies should be determined based on the
intensity of intervention
required for a patient. The continuum of treatment setting intensities
ranges from episodic office-based therapy to intensive inpatient
therapy. For more information on this topic refer to the American
Society of Addiction Medicine’s Patient Placement Criteria
(ASAM PPC-2R, (www.asam.org), the most widely used and comprehensive
national guidelines for placement, continued stay, and discharge
of patients with alcohol and other drug problems.
Many different types of behavioral therapies (e.g., Motivational
Enhancement Therapy, self-help programs) have been used successfully
for substance abuse disorders. The SAMHSA Treatment Improvement Protocol
(TIP) series (http://www.samhsa.gov/publications/publications.html)
includes a number of documents that contain best practice guidelines
for the provision of interventions and therapies for individuals
with substance abuse disorders.
Opioid Addiction Therapy with Buprenorphine
This section
provides a brief overview of the clinical use of buprenorphine
(Suboxone® and
Subutex®) for opioid addiction therapy.
For detailed information on this topic see the Buprenorphine Clinical
Practice Guidelines (available soon). 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-dependent 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 the patients have discontinued
or greatly reduced the use of their 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.”
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