Both clinical and practical considerations are involved in deciding which patients
are appropriate for levo-alpha-acetyl-methadol (LAAM) treatment. Patients
can be inducted directly onto LAAM or can be transferred from methadone to
LAAM. This chapter provides guidelines for selecting patients for LAAM treatment
and stabilizing them on the medicine.
Dose scheduling is key to successfully maintaining stabilized patients on LAAM.
Two factors specific to LAAM--its long-acting nature and the fact that
regulations do not permit take-home doses--make dose scheduling more complicated than
with methadone. Dosing can be scheduled every other day, if the clinic is open
on Sunday. Three-times-weekly dosing (two 48-hour doses and a 72-hour dose)
can also be used. Programs should have procedures for addressing Monday holidays
and other planned and unplanned interruptions of regular LAAM dosing. For
planned absences, supplemental doses of methadone may be given to patients who
are allowed take-home methadone. The chapter describes approaches to addressing
dosing and scheduling issues.
Research to date provides no clear-cut indicators that determine which individuals
will benefit most from LAAM therapy. Until more ic effects of drugs used to
supplement LAAM.
People who have been on methadone maintenance a long time but still report for
medication six or seven times a week because of State or local policy on take-home
methadone. These patients in particular may appreciate that fewer clinic visits are
required by LAAM therapy.
Chronic relapsers, including those who have been on methadone for a long time but
who remain uncommitted to the goals of treatment. Most chronically noncompliant
patients do not appear to benefit from daily visits to the clinic, and many visit
the clinic only because they are not allowed take-home medication. Many such
patients disrupt clinic routines and, over a long period of time, have exhausted
staff attempts to engage them in treatment. Members of the consensus panel felt
that use of LAAM therapy with some of these patients would have the advantage
of reducing disruptive clinic visits and making it easier for staff to provide
care to others. Panel members understood that recommending LAAM therapy for
this group was controversial; patients in this group should be carefully selected.
LAAM therapy should never be used as a punishment.
Daily clinic attendance by the three groups may be reduced with LAAM therapy.
Patients who have been stable on methadone maintenance for a period of
years probably receive take-home doses and would experience no reduction in visits
when transferring to LAAM. However, according to Federal regulations, a patient
must be in opioid substitution therapy for 2 years before he or she is eligible
for enough take-home methadone to allow only two clinic visits per week. Thus,
patients in the first 2 years of methadone treatment may benefit from LAAM therapy.
(After 3 years of treatment, the Food and Drug Administration [FDA] regulations
permit a 6-day supply of methadone for patients meeting certain conditions, thus
allowing them once-a-week clinic visits. State regulations vary.)
In considering candidates for LAAM therapy, common sense and practical considerations
should prevail. Patients with mobility problems may find LAAM treatment an attractive
alternative, because fewer visits mean less frequent travel requirements. Similarly,
patients in inner cities who lack transportation, those in rural areas who must
drive long distances to the clinic, and those with scheduling conflicts may also
find LAAM therapy a desirable alternative. Patients (such as those with
dementia) for whom age or illness makes managing take-home medication difficult may
also derive some benefits. Patients in States where take-home doses of methadone
are not allowed or are in practice severely restricted may also benefit from
the introduction of LAAM treatment. Patients in these States could have more
opportunities to engage in other productive life experiences (such as employment and
job training) under LAAM's reduced dosing schedule. However, treatment choices
based on these considerations alone should be avoided.
Although use of LAAM raises these and other practical issues, the decision to use
LAAM should be governed by clinical factors, including the patient's desire
and the belief that LAAM offers the optimal means for achieving the goals of
maintenance treatment. LAAM therapy should not be selected because a clinic is trying
to achieve formulas or meet quotas of LAAM patients.
The decision to use LAAM should be framed from the patient's perspective.
Staff may find it useful to present the available range of opiate addiction treatment
alternatives to a patient in a manner similar to that used in family planning counseling.
Such conversations may extend over more than one counseling session to
allow the patient to assimilate the information. (However, treatment with methadone
can begin right away.) To help the patient make an informed choice, program
staff should present the advantages and disadvantages of the treatment options
and give the patient the opportunity to ask questions and to participate in
the treatment selection.
Every treatment choice has particular advantages and disadvantages. For example,
some patients may need daily clinic visits as a component of their treatment
program; less frequent visits may help other patients establish a more normal routine
that is not as structured around clinic visits as is necessary when receiving
methadone. For the latter group, use of LAAM offers distinct benefits. Although
use of LAAM eliminates the need for daily clinic visits, it also eliminates
the option of take-home medication. For some patients, the loss of take-home
medication as an indicator of treatment progress may present problems. For others,
take-home medication may not be achievable, and LAAM will provide an alternative
method of reducing the frequency of clinic visits.
The components of the psychosocial assessment for LAAM therapy are consistent
with those for methadone treatment. Guidelines for assessment of patients are
presented in two other TIPs State Methadone Treatment Guidelines and Matching Treatment to Patient
Needs in Opioid Substitution Therapy.
Patients who are being considered for LAAM therapy can be divided into two major
groups: those who are already in an opioid substitution therapy program and those
who are not. The latter category includes patients who are not currently dependent
on opioids, for example, those recently released from incarceration or chronic
care institutions who meet FDA criteria for admission without proof of current
physical dependence, 21 C.F.R. Part 291 Section 291.505(d)(1)(iii)(A) (1993).
Patients who are appropriate candidates should be offered other treatment options
if they are not able to tolerate LAAM therapy.
Federal eligibility requirements for methadone maintenance treatment stipulate
that people with a minimum 1-year history of opiate addiction and who have current
physical dependence may enter maintenance treatment. The minimum age requirement
is 18 years; persons between 16 and 18 years of age may enter methadone treatment
under certain conditions. There is no upper age limit on entry to care. Pregnant
women may be accepted for methadone treatment and, with special medical justification,
may be admitted under modified criteria. Persons with major medical conditions
are eligible for treatment, as are polydrug abusers. Details on methadone
eligibility guidelines are found in the TIP State Methadone Treatment Guidelines.
Federal eligibility requirements for LAAM treatment are identical to those for
methadone, with the following three major exceptions. LAAM is not approved for use
by
LAAM is classified by FDA as a category C drug, that is, a drug for which "animal
studies show adverse effects on fetus but no adequate studies in humans; benefits
from drug during pregnancy may outweigh risks, OR no animal reproduction studies
and no adequate human studies," 21 C.F.R. Part 291 Section 201.57(f)(6)(i)(c) (1994).
Federal guidelines state that because LAAM is not approved for use during
pregnancy or while nursing, "patients who are or become pregnant cannot be started
or continue on LAAM, except by written order of a physician who determines
this to be the best choice of therapy for the patient" (Food and Drug Administration, 1993).
Any predictions of the effects of LAAM on pregnant or nursing women and the
fetus at this time are speculation. For example, because of its slower action,
LAAM may produce fewer withdrawal effects on the fetus; on the other hand, LAAM
metabolites might accumulate in utero. Like other mu agonist opioids, LAAM may cause respiratory
depression in the fetus and other perinatal complications during delivery. It is
not known whether LAAM is excreted in breast milk.
Many other drugs have been approved for use during pregnancy, even though their
effects on the fetus and newborn are unknown. When there is no treatment alternative,
the physician must decide whether to treat a pregnant woman. However, an adequate
and proven substitute for LAAM exists - methadone. Until research has demonstrated
the safety of LAAM in pregnant women and nursing mothers, it is recommended
that patients who become pregnant or are nursing be transferred to methadone.
Exceptions to this practice are likely to be extremely rare. The sole
circumstance under which LAAM might be acceptable is when the only alternative is a
return to heroin use.
Counseling concerning the potential risks of LAAM during pregnancy and nursing should
be provided to both male and female patients. Women should receive written
and oral information about the potential risks of taking LAAM during pregnancy,
and this information should be periodically reinforced.
Regular pregnancy testing should be available in all substance abuse treatment
programs; women with substance abuse problems are a high-risk population in terms
of receiving poor prenatal care. Testing for sexually transmitted diseases
(STDs) as well as for human immunodeficiency virus (HIV) should also be made routinely
available to these patients. These tests should be offered, along with onsite access
to or referral for family planning services and counseling. Regular pregnancy
testing for patients receiving LAAM may be more easily integrated into the program
if it is presented as part of an overall women's health initiative.
Mandatory pregnancy testing should be presented to women as a positive treatment
benefit. Testing has many benefits, provided that positive results are followed
up by good prenatal care and appropriate support. Open discussion of issues
related to reproductive health can strengthen the patient-staff relationship, which
may in turn enhance treatment progress.
Federal regulations prohibit any person under 18 years of age from entering LAAM
maintenance treatment because there are no adequate studies to support its use among
persons of this age. Some people question whether arbitrary limits such as these,
in the absence of clinical data, are counterproductive. Studies are needed
to provide a scientific basis for the exclusion of any group of patients from
LAAM therapy.
Use of LAAM has been studied in several subgroups of patients, and results
are summarized below.
Persons with comorbid medical conditions. Persons with elevated liver enzyme
levels should not automatically be ruled out as candidates for LAAM therapy.
LAAM treatment is generally not recommended for persons with hepatic failure.
(For further information on the effects of liver disease, see Chapter 1.)
Persons with comorbid psychiatric conditions. A person should not be excluded
as a candidate for LAAM therapy solely on the basis of psychiatric symptoms.
There is generally no reason to believe that the treatment of patients
with coexisting psychiatric illness should be different with LAAM than with
methadone. Psychiatric symptoms should be evaluated and treated, and decisions about
maintenance therapy made in conjunction with the provision of such treatment.
Patients who do not succeed on one of the two opioid agonists available for treatment
(methadone and LAAM) should be tried on the other if there are no contraindications
(such as pregnancy). Anecdotal reports indicate that some patients may benefit
from LAAM therapy because they experience a more level effect than with methadone;
some patients receiving methadone report an "up-and-down" cycle.
Patients with previous experience of side effects from LAAM. Persons who have
experienced side effects from the drug in the past are generally inappropriate candidates
for LAAM treatment.
Psychosocial considerations. Some patients have avoided opioid substitution therapy
because of the stigma associated with methadone. The question of whether they
are appropriate candidates for LAAM treatment cannot be answered with a simple
"yes" or "no." The counselor's first task is to ensure that the patient has
been given the information necessary to make an informed choice. Sensitive
counseling can alleviate anxiety and facilitate rational decisionmaking.
An understanding of the basics of steady-state pharmacology is essential for
the safe induction of patients onto methadone or LAAM therapy. When a drug
is given at regular intervals before the previous dose is eliminated from
the body, there is an accumulation of the drug in the body until a steady state
is reached. The term steady state refers to a condition in which the amount of a drug entering
the body is equal to the amount being excreted, which allows a relatively constant
serum (blood) level of the drug. For any drug, the time needed to reach steady
state is a function of its elimination half-life. The half-life is the amount
of time required for the body to eliminate half of a given dose of a drug.
It is important for physicians, staff, and patients to understand that the
second dose is added to the portion of the previous dose that is still in the
body, resulting in higher blood levels with no increase in dose. This continues
until steady state is achieved.
The terms steady state and stabilization should not be confused.
Steady state has been achieved when the dose of LAAM administered lasts
for the intended length of time. In contrast, a patient is stable when he or she no longer exhibits drug-seeking behavior or craving. At
this point, both the patient and supportive services staff can begin to focus
on medical, lifestyle, and psychosocial issues, and on other treatment.
Steady state is based on multiples of the elimination half-life. Approximately
four to five half-life times are needed to establish the steady state. For
example, methadone has a half-life of 1 to 1.5 days (24 to 36 hours); therefore,
the steady state for methadone--that is, the time at which a relatively constant
dose level is present in the body -- is achieved in 5 to 8 days in most patients
(see Exhibit 3-1).
It takes longer to reach a steady state of LAAM in the body because the parent
drug and each metabolite (nor-LAAM and dinor-LAAM) have a longer half-life than
methadone. The half-life of LAAM (parent drug) is 2.6 days, that of nor-LAAM, 2 days,
and that of dinor-LAAM, 4 days. Because of their different half-lives, each
requires a different time to achieve steady state; the length of time is calculated
by multiplying the half-life by a factor of four to five (Exhibit 3-1). Thus, although the first dose of LAAM, if it is adequate, will
eliminate withdrawal symptoms, and such symptoms should be well controlled by the
second or third dose, the pharmacological steady state is not realized for 16
to 20 days.
Patients selected for LAAM therapy can be inducted onto the medication either by
direct induction onto LAAM or by a standard methadone induction followed by a
change to LAAM once the patient is stabilized on a methadone dose. The program's
clinical staff, in consultation with the patient and family (with patient consent),
can choose between these two options. With either method of induction, LAAM
offers clinicians a choice in how to carry out induction--a choice that can affect
outcomes. No choice should be irreversible, however, and clinicians should be open
to trying another induction method if the initial decision does not appear
to be effective. Although the current literature on LAAM therapy provides
no clear indications to direct clinicians and practitioners in this decision,
the guidelines that follow may be helpful.
Induction onto a stabilizing regimen of methadone before LAAM treatment is begun
affords clinicians the ability to observe the patient on a daily basis. Such an
approach can be helpful if the patient is dependent on other drugs, including alcohol.
Patients who are initially inducted onto methadone may expect a more rapid
onset of effect, which may be an advantage in some cases. Another potential
advantage of methadone induction may be the clinician's familiarity with methadone's
action and side effects.
Direct induction onto LAAM also may be preferable for certain patients because
of logistical considerations. For example, patients with transportation problems
or with work-related or other scheduling problems may find LAAM therapy attractive
because it reduces the frequency of clinic visits.
Patients who have not had a positive experience with methadone in the past also
may prefer direct induction onto LAAM. Although most methadone-maintained
patients experience a very stable 24-hour dose response, some patients' response
to methadone may fluctuate during a 24-hour period, perhaps because of fluctuations
in blood levels of methadone caused by individual differences in metabolism.
These patients may benefit from the longer action and more stable dose
response to LAAM over the 48- or 72-hour period between doses.
Before inducting a patient directly onto LAAM, staff should consider other factors.
Some patients may desire or need daily contact with staff early in treatment.
Patients who need such contact, whether for medical or psychiatric reasons,
as well as those who may need medication readjustment, might be cautioned
against entering directly into LAAM therapy from street opiate use. These patients
can be seen at the clinic on nondose days. Active alcoholics, as well as persons
who abuse other sedative-hypnotics, also merit special attention.
Nonetheless, if the patient strongly desires to begin treatment with LAAM and treatment
staff believe that it is in the patient's interest to do so, a treatment plan
may be developed that permits this option. Arrangements could be made, for
example, for daily clinic visits. The drug administration schedule need not govern
the frequency of patient contact.
Once LAAM becomes available in an opioid substitution therapy program, all patients
should be educated about the new medication and provided as much information as
possible. Some guidelines for switching patients from methadone to LAAM are offered;
however, clinical judgment should prevail in individual cases.
Patients who are stable. A patient who is eligible for LAAM therapy and is
stable on methadone maintenance might be considered for a change to LAAM. Such
individuals often do well on LAAM. Acceptance of the medication is generally greater
in patients with better psychosocial functioning. Some of these patients
describe a "smoother" effect with LAAM as well as a decreased narcotic effect.
Patients who are not progressing well. Patients who are not doing well on methadone
may also be considered for LAAM therapy. This may be the case, for example,
for certain patients who assimilate methadone quickly and who consequently
use heroin as a supplement. Although the use of LAAM may be an appropriate
option in these situations, other options, such as increasing the methadone dose,
should also be considered.
Noncompliant patients. Some patients receive methadone maintenance for years with
little progress. They do not comply with their treatment plan and chronically
cause problems and disruptions in program routine. Take-home doses of methadone
are not an option for these patients. A change to LAAM may be an option.
It is possible that a new medication will offer therapeutic benefits to the
patient and reduce disruptions in program routine caused by the daily visits of
a problematic patient. As discussed above, patients in this group who are
tried on LAAM therapy should be carefully selected and monitored.
When patients are noncompliant and disruptive to clinic routines, staff should
begin by counseling the patient about the effects of his or her conduct on clinic
morale and operations. Efforts should be made to identify the reasons for the
patient's conduct and to resolve them. Should this fail, staff may discuss treatment
options, including referral to other treatment modalities in addition to LAAM.
The process of induction onto LAAM therapy is essentially the administration
of a safe initial dose, which is given to relieve the signs and symptoms of
withdrawal and abstinence. Additional doses are adjusted up or down in an effort
to approximate the established tolerance threshold of each patient to prevent
further symptoms and to reduce or eliminate the desire or craving to continue use
of illicit drugs.
A later phase of induction involves slower, more gradual dose adjustments
to establish an adequate maintenance dose that ensures the desired effects
for the individual patient. The initial dose is determined by the patient's
degree of tolerance.
An induction chart is provided in Exhibit 3-2. The
chart is for reference only. No such chart can replace direct communication
between patient and clinician. Clinicians must speak directly to a patient and
to others involved in the patient's care to determine the patient's individual
reactions to the medication and to adjust the dosage accordingly.
For opiate-addicted persons who are not in treatment, the initial dose of LAAM
is 20 to 40 mg. Patients who are stabilized on methadone are crossed over
to LAAM at a starting dose equal to 1.2 to 1.3 times their daily methadone
dose, not to exceed 120 mg. Subsequent doses may be adjusted by 5 to 10 mg until
the patient is stable. Doses should not exceed 140 mg. If a dose of more
than 140 mg is prescribed, it must be justified in the medical record, 21 C.
F.R. Part 291 Section 291.505(k)(1)(D) (1993).
Especially during induction onto LAAM, patients may need explanation and reassurance
that more time, rather than more medication, is needed if full relief is not
felt within 48 hours. After all three LAAM compounds have become active and
steady state has been achieved, their combined activity produces what many patients
describe as feeling more "normal."
In contrast to methadone, which acts quickly in the body, patients may not
feel the full benefit of the initial LAAM dose for 6 to 8 hours, until the body
metabolizes LAAM into nor-LAAM and dinor-LAAM. Because of this slow onset of effect,
patients on LAAM may experience symptoms of withdrawal between scheduled LAAM doses
during the induction phase.
Although Federal regulations prohibit LAAM from being given more frequently than
every other day, methadone is an appropriate and effective supplement because
of its relatively rapid onset of activity (2 to 4 hours). During the induction
period, patients can be given small doses of methadone (10 to 20 mg) on days they
do not receive LAAM to provide more rapid relief of any discomfort and reduce
the risk that they will use illicit drugs. Persistence of withdrawal symptoms
indicates that the LAAM dose is inadequate, and the induction schedule should be
adjusted accordingly.
Throughout LAAM therapy, particularly during the first 2 weeks of induction, patients
need a great deal of reassurance, support, and information. To a large extent,
the successful implementation of treatment with LAAM depends on having well-trained
staff who are available to support and educate patients. Clinical trials with
LAAM showed that when program staff did not accept LAAM therapy as a potential
alternative to methadone treatment or were not properly informed about counseling and
casework issues, patients also tended not to accept LAAM.
The goal of maintenance treatment is to develop and implement a rehabilitation
program that recognizes the chronic, relapsing nature of opiate addiction and allows
adequate time to ensure successful long-term remission of the addictive disorder.
The treatment plan should be based on the clinical needs of the patient.
Arbitrary time limits to a treatment episode are counterproductive and
contrary to established principles of high-quality care. Treatment decisions should
be based on ongoing dialogue between the patient, counselor, and members of
the treatment team.
As is the case for methadone and other medications, the use of LAAM requires
ongoing assessment and review of the treatment plan. At a minimum, FDA regulations
require that treatment plans be reviewed every 90 days for the first year and every
180 days thereafter. Patient contact with treatment staff should occur as
frequently as treatment plans require, and contact should be no less frequent than
monthly.
Decisions about LAAM dosages should be made on a patient-by-patient basis. Extensive
research shows that inadequate dosages of methadone play a significant role in the
continued abuse of illicit drugs. In clinical trials, this was also true of LAAM;
therefore, each patient's LAAM dosage should be sufficient to suppress
drug withdrawal symptoms, illicit drug-seeking behavior and use, and associated
high-risk behavior.
A key issue in treatment planning is dose scheduling. LAAM doses can be
given either every other day or three times a week (two 48-hour doses and a 72-hour
dose). However, every-other-day LAAM dosing is an option only if the clinic is
open on Sunday--that is, 7 days a week. Monday-Wednesday-Friday schedules are
often convenient for clinic operation and provide the patient with a weekend
with no required clinic visit. In practice, the administration schedule for
LAAM may be set to fit the clinic's convenience. As far as possible, however,
it should also be tailored to the individual patient's comfort, convenience,
and other needs.
Clinical experience with LAAM to date indicates that patients enjoy having weekends
without a trip to the clinic and that nearly all patients do extremely well on
a 48-hour interval. However, the 72-hour interval, from Friday to Monday,
is a problem for some patients who may experience some discomfort, usually
late on Sunday, or whose anxiety about the 72-hour interval becomes a clinical
issue. A primary task of the counselor is to educate and reassure the patient
about LAAM's long-acting nature.
While a few patients take the same LAAM dose on Monday, Wednesday, and Friday,
most will benefit from an increase in LAAM on Friday (10 to 40 percent more
than the Monday and Wednesday doses) or an increase in LAAM on Friday and a
small dose of methadone to be taken home and used on Sunday. For very stable
and reliable patients, the best option may be a regular LAAM dose on Friday
and a full methadone dose (80 percent of the LAAM dose) as a take-home dose
for Sunday.
Exhibit 3-3 shows a chart used by one clinic to calculate
the correct dose of LAAM and of methadone for patients on a Monday-Wednesday-Friday
LAAM dosing schedule. For example, a patient on 100 mg of LAAM who is allowed
take-home doses of methadone would be given a 100-mg dose of LAAM on Monday and Wednesday;
on Friday the patient's LAAM dose would increase by 20 percent and he or
she would take home a methadone dose of 30 mg for Sunday. As shown in the
chart, for patients for whom take-home methadone is not appropriate, the approach
is to increase the Friday dose of LAAM by 30 percent to cover the 72-hour
period during which the patient receives neither LAAM nor methadone. (According
to Federal regulations and most State regulations, all patients are eligible
for one take-home dose of methadone. However, the program may decide not to
allow a patient to take home any doses.)
Not enough data are available to determine whether the optimal clinical benefit
of LAAM is achieved with an every-other-day or a three-times-weekly schedule.
More studies are needed to elucidate this point. For opioid substitution
therapy programs, the currently approved LAAM dosing schedules raise both clinical
and practical issues that should be explored.
Treatment programs should have plans in place to handle expected or unexpected interruptions
in therapy, whether these breaks are short or long. Many circumstances, such
as work-related travel, illness, funerals, planned vacations, and emergencies
may arise that require patients to miss clinic visits. If it is impossible
to maintain an every-other-day or three-times-weekly schedule of LAAM, methadone
should be substituted to allow patients to continue treatment without interruption
for absences of more than 3 days from LAAM. Because current FDA regulations
do not allow take-home doses of LAAM, treatment programs should have methadone
available.
Disability or illness. When patients are unable to come to the clinic on their own
or to be brought there with assistance because of disability or illness, authorized
clinic staff can use curbside delivery and observed-dose procedures to ensure
continuity of treatment. Because LAAM and methadone are tools in a comprehensive
treatment program, clinics should evaluate the need for continuity of support services
as well as medication in these circumstances.
When doses are missed, it is critical for the clinician to evaluate the patient
to determine the patient's present condition. Has the patient been using
illicit drugs or taking other medications? Clear guidelines are available about
the clinical management of patients who have missed scheduled LAAM doses:
One dose missed. For patients who miss one scheduled dose and come to
the clinic the next day (that is, 3 to 4 days after the last LAAM dose), the
preceding day's dose should be given and the rest of the week's schedule should be
changed accordingly with a return to the regular schedule the following week.
For example, for a patient on a Monday-Wednesday-Friday schedule who misses
the Monday dose and comes in on Tuesday, the schedule is changed to Tuesday-Thursday-Saturday
for that week only and returns to the regular schedule the following week.
For patients who miss a dose and come to the clinic 2 days later, when their
next scheduled dose is due (that is, 4 to 5 days after their last LAAM dose),
the scheduled dose is usually well tolerated. Some clinicians may prefer to
reduce the dose slightly (for example, by 5 to 10 mg) and return the patient to
a stable dose at the next clinic visit. Good clinical judgment and knowledge
of the patient are important factors in this situation.
More than one dose missed. For patients who miss more than one dose, reinduction
should begin with an initial dose of one-half to three-quarters of the previous
dose. Tolerance to LAAM begins to drop to some extent, so that a full dose given
after more than one missed dose could result in some degree of impairment or
intoxication. LAAM can then be increased by 5 to 10 mg every scheduled day, whether
the schedule of administration is every other day or three times a week, until
the patient reaches the previous maintenance dose.
More than 1 week off LAAM. For patients who miss more than a week of scheduled
LAAM doses, the induction process should be repeated.
When take-home methadone is used as a supplement to LAAM therapy when interruptions
in treatment are anticipated, the number of doses must be calculated carefully
so that it is adequate for following the schedule. The first methadone dose
should be taken 48 hours after the last observed dose of LAAM, and the last methadone
dose should be taken 24 hours before the next scheduled dose of LAAM at the
clinic.
Holidays and vacations. For patients taking LAAM every other day, the schedule
can be adjusted so that a Monday holiday falls on an "off" day. If the schedule
cannot be modified, methadone can be provided at 80 percent of the 48-hour dose,
with instructions to take it 48 hours after the last LAAM dose.
For vacation and travel plans, methadone can be substituted for LAAM in the
same manner as for a Monday holiday. If 80 percent of the patient's LAAM dose
is more than 100 mg of methadone, however, clearance from the State authority
and FDA may be necessary because of the dose limit for take-home methadone,
21 C.F.R. Part 291 Section 291.505(d)(6)(iv) (1993). To be compliant, each
program must be aware of State-specific regulations in addition to Federal regulations.
Hospitalization. Opioid substitution therapy programs are responsible for ensuring continuity
of treatment for patients who are hospitalized. Programs often find provision
of this continuity to be a problem, because some hospitals are unfamiliar
with or have philosophical or ideological objections to substitution therapy.
Although methadone is available in some hospitals for analgesia and to
continue maintenance for patients, some specialty hospitals do not even stock methadone.
Hospitals initially will not carry LAAM, and methadone will have to be
substituted. They may need to consult program staff on the appropriate conversion dose
of methadone to substitute for LAAM. Programs should explore ways to educate
hospitals and treating physicians in their communities about the needs of LAAM-maintained
patients.
Federal regulations state that "Hospitalized patients under care for a medical
or surgical condition are permitted to receive LAAM in oral form when the
attending physician judges it to be advisable." In such cases, authorized clinic
personnel can deliver and administer LAAM to their patients. If the attending physician
does not permit the use of LAAM, the patient can be transferred to methadone,
which most hospital pharmacies can provide. If doubt about the legality of providing
LAAM or methadone remains after hospital staff have seen the pertinent Federal
regulations, the State authority can be contacted for verification.
The best practice is for clinic staff to stay in touch with and be involved
in the education of the patient's hospital clinician. For example, hospital
house staff may not be aware that certain drugs, such as a mixed agonist and
antagonist for pain management, should not be prescribed for patients receiving LAAM
or methadone. (See Chapter 1 for more information about pain management in LAAM-maintained
patients.) Communication between program and hospital staff raises confidentiality
issues, and information about confidentiality should be included in treatment programs'
educational presentations to the health care community. The patient's consent is necessary
for this kind of program-hospital communication, but a medical emergency supersedes
confidentiality regulations. If it is conducted professionally and with linkage and cooperation
as goals, this kind of coordination of care can enhance the status of treatment
program personnel with hospital staff.
Hospitalization, particularly of unconscious patients, raises the issue of the use of identification
(ID) cards. ID cards, in turn, raise privacy issues. One large urban opioid
substitution therapy program provides patients with a photographic ID card to gain admittance
to the clinic. The program's experience is that some patients use their clinic
card as a generic photographic ID in lieu of a driver's license; for example,
they use it to cash checks, despite the fact that the card identifies them as
being in treatment. "Smart cards" containing a complete medical history are
already in use in the United States, Israel, and Holland and may be useful in opioid
substitution therapy programs. These cards would contain electronically encoded information
needed by the program to identify and monitor the patient; they would not outwardly
identify the card holder as a patient.
LAAM's long-acting characteristics have critical implications for the treatment
of overdose or oversedation, which is more likely to occur in new patients
than in dose-stable patients. Almost all overdoses in LAAM patients involve
a combination of sedative drugs. In such cases, the ABCD approach is appropriate
for first aid:
A - Airway: make sure it is clear.
B - Breathing: ensure adequate breathing and ventilation.
C - Cardiac: check cardiac status and ensure circulation.
D - Drugs: Use naloxone if needed (an opioid antagonist) to counter the
effects of LAAM.
In the standard treatment of overdose, naloxone may be administered. If naloxone
is used, however, it is important to recognize that LAAM is long acting (effective
for up to 48 hours) and naloxone is short acting (effective for .5 to 1 hour).
This difference in duration of action means that the patient may respond
to naloxone initially and then lapse into coma again when the effects of naloxone
wear off but the effects of LAAM remain. For this reason, patients who have
overdosed should be kept under observation for a minimum of 48 hours and given repeat
naloxone by injection or continuous drip as needed. If a patient who has overdosed
is hospitalized, house physicians may need to be educated about the different
duration of activity of LAAM and naloxone. Programs should ensure that emergency
services in their areas have the latest outlines for treating clients who are on
LAAM for medical emergencies and who have had overdoses related to opiates,
cocaine or crack, alcohol, or prescription medications.
Few studies have addressed the medically supervised withdrawal of LAAM patients
to a drug-free state. No evidence exists, however, to suggest that withdrawal
from LAAM is different from withdrawal from methadone or any other opioid.
Because patient motivation is essential to success, it is very important that patients
initiate the process. Any patient who asks to be withdrawn from LAAM has the right
to a medically supervised withdrawal program. The decision to withdraw from
LAAM treatment is a highly complex process that should take into account several
factors, including level of stability, past levels of functioning without medication,
and fear of detoxification (Moolchan and Hoffman, 1994).
Withdrawal and termination from LAAM therapy are highly patient-specific processes.
For the LAAM-maintained patient who is psychosocially rehabilitated and
wishes to achieve drug-free status, the LAAM dose can be reduced gradually at
a rate determined by the patient's response. The LAAM dose levels presented
in Exhibit 3-3 (earlier in this chapter) show an example of such a gradual reduction.
Clinic staff should be aware that patients often have a great fear of protracted
periods of withdrawal. Because LAAM is longer acting than methadone, withdrawal
is expected to have a delayed onset and protracted course, although the withdrawal
may be less intense than with other opioids. Patients, however, tend to perceive
a longer period as being worse, whether the actual intensity of symptoms
is greater or not. Special counseling may be needed to address this aspect
of withdrawal from LAAM.
As an alternative, patients who want to withdraw from LAAM treatment can be
switched to methadone and then have their medication tapered. They can be transferred
to methadone at 80 percent of their LAAM dose with minimal difficulty. The
key issue in this decision may be the support system the patient needs; take-home
methadone entails fewer clinic visits. Although patients can visit the clinic on
nondose days for support services only, they are less likely to do so without the
incentive of receiving a medication dose.
When involuntary withdrawal from medication is unavoidable, patients should
be transferred to methadone before withdrawal is begun so that they can be
observed on a daily basis and because clinical experience with methadone withdrawal
is more extensive. Also, because of the shorter half-life of methadone, it
may be possible to withdraw a patient more rapidly from methadone, a course
which is usually desirable in involuntary situations.
When a patient knows that he or she must serve time in jail or prison, such
a planned withdrawal is best. Only one jail facility in the country - Rikers
Island, the central jail facility in New York City - is known to provide methadone
maintenance. Most jails do not even provide methadone for detoxification. When a patient
is arrested, program staff should make every effort to communicate with criminal
justice authorities and to recommend that the patient be withdrawn over a period
of time. Whether the patient is maintained on LAAM or methadone, some form
of maintenance or detoxification is preferable to sudden withdrawal of the
medication.
The decision to terminate treatment with LAAM involves the same considerations
as the decision to terminate treatment with methadone. Patients should be
encouraged to stay in treatment as long as necessary to allow them to make the therapeutic
changes that will support a drug-free lifestyle. Patients should not be pressured
to discontinue treatment to meet arbitrary deadlines. There is no evidence
that any specific duration of therapy is an adequate treatment "dose." The
decision to attempt to withdraw from LAAM treatment should be made jointly by the
patient and the treatment team.
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