Maintenance Treatment With Buprenorphine

 

There is no failure except in no longer trying. There is no defeat except from within, no really insurmountable barrier save our own inherent weakness . ---Kin Hubbard

The three phases of maintenance treatment with buprenorphine for opioid addiction are:
(1) Induction
(2) Stabilization
(3) Maintenance

Induction Phase

Buprenorphine  induction  (usual  duration  approximately  one week), the first phase of treatment, involves helping a patient begin the process of switching from the opioids of abuse to buprenorphine. The goal of the induction phase is to find the minimum dose of buprenorphine at which the patient discontinues or markedly diminishes use of other opioids and experiences no withdrawal symptoms, minimal or no side effects, and no uncontrollable cravings for drugs of abuse. The physician should assess for signs and symptoms of withdrawal or inadequate dosing during induction. Patients should be advised to avoid driving or operating other machinery until they are familiar with the effects of buprenorphine and their dose is stabilized. Induction protocols differ, depending on the type of opioid to which the patient is addicted (e.g., short - or long -acting) and whether or not the patient is in active withdrawal at the time of induction.

The consensus panel recommends that physicians administer initial induction doses as observed treatment (e.g., in the office); further doses may be provided via prescription thereafter. This ensures that the amount of buprenorphine located in the physician's office is kept to a minimum. Following the initial buprenorphine dose, patients should be observed in the physician's office for up to 2 hours. For patients who do not experience excessive opioid agonist symptoms after the initial dose, induction protocols can be followed as described below.

Induction Days 1 and 2: Who Is the Patient and What Does He or She Need?

It is important to identify the opioid(s) that patients have been using, as the response to buprenorphine treatment in individuals dependent on long-acting opioids is different than that seen with short-acting opioids and, therefore, the appropriate induction protocol must be chosen. Most patients starting buprenorphine induction will be physically dependent on a short-acting opioid (e.g., heroin, oxycodone, hydrocodone) and should be in the early stages of withdrawal at the time they receive their first dose of buprenorphine.

Patients Dependent On Short-Acting Opioid

Before the initial buprenorphine induction dose is administered to a patient dependent on short-acting opioids, a minimum of 12-24 hours should have elapsed since the last use of opioids. The patient should preferably be exhibiting early signs of opioid withdrawal (e.g., sweating, yawning, rhinorrhea, lacrimation). Patients who are not in active withdrawal because they have not abstained from using opioids for a sufficient period should receive a careful explanation of the advantages of waiting and should be urged to wait until they begin to experience the symptoms of withdrawal.

Patients   who   are   experiencing   objective   signs   of  opioid withdrawal and whose last use of a short -acting opioid was more than 12-24 hours prior to the initiation of induction can receive a first dose of 4/1-8/2mg  of the buprenorphine/naloxone combination (buprenorphine monotherapy for pregnant women).

If the initial dose of the buprenorphine/naloxone combination is 4/1 mg and opioid withdrawal symptoms subside but then return (or are still present) after 2 hours, a second dose of 4/1 mg can be administered. The total amount of buprenorphine administered in the first day should not exceed 8 mg.

Patients Dependent on Long -Acting Opioids

Induction onto buprenorphine from long-acting opioids (e.g., methadone) may be complicated and is best managed by physicians experienced with this procedure. If this treatment will be conducted in an office-based setting, the physician's office must contact the patient's Opiate Treatment Program (after receiving signed consent) to determine the methadone dosage levels and time of last dose. Such contact will ensure that the physician knows the exact quantity and time of the last methadone dose, as well as prevent patients from receiving opioid agonist treatment  and office-based buprenorphine treatment simultaneously. To allow this exchange of addiction treatment information per Federal confidentiality Regulation 42 C.F.R. Part 2.  The patient must provide signed consent to both the OTP and the buprenorphine -treating physician.

For patients taking methadone, the methadone dose should be tapered to 30 mg or less per day for a minimum of 1 week before initiating buprenorphine induction treatment. Patients should not receive buprenorphine until at least 24 hours after the last dose of methadone. The first dose of buprenorphine should be 2 mg of the monotherapy formulation. If a patient develops signs or symptoms of withdrawal after the first dose, a second dose of 2 mg should be administered and repeated, if necessary, to a maximum of 8 mg buprenorphine on Day 1.

It   should    be    noted    that   not   all   patients   maintained  on   methadone may be good canditates for the switch to buprenorphine treatment at a methadone dose of 30mg /day. As  a  methadone  taper  approaches 30mg/day many patients
become uncomfortable, develop withdrawal  symptoms, and are at an increased risk of relapse to opioid abuse.  Such patients may request the transfer to buprenorphine at higher daily doses of methadone. The decision to transfer a patient to
buprenorphine at higher daily methadone doses should be based on clinician judgement, informed by the patient's subjective and objective findings.  While there has been case reports of transferring patients to buprenorphine from methadone as high 80mg/day, there is insufficient data to formulate recommendations regarding which patients may be able to  tolerate a switch at these higher doses or the best way to manage the transfer. 

Induction Management When Withdrawal Symptoms Are Not Relieved by 8 mg Buprenorphine in the First 24 Hours

If withdrawal symptoms are still not relieved after a total of 8 mg of buprenorphine on Day 1, symptomatic relief with nonopioid medications should be provided and the patient asked to return the following day for dose management.

Patients Not Physically Dependent on Opioids

Patients who are not physically dependent on opioids but who have a known history of opioid addiction, have failed other treatment modalities, and have a demonstrated need to cease the use of opioids, may be candidates for buprenorphine treatment. Patients in this category will be the exception rather than the rule, however. Other patients in this category would be those recently released from a controlled environment who have a known history of opioid addiction and a high potential for relapse.

Patients  who  are  not  physically dependent on opioids should receive the lowest possible dose (2/0.5mg) of buprenorphine/naloxone for induction treatment.

Induction Day 2 and Forward

If  buprenorphine  monotherapy  was  administered  on  Day 1, switch to buprenorphine/naloxone on Day 2 (for a patient who is not pregnant).

For patients who do not experience any difficulties with the first day of buprenorphine dosing, and who are not experiencing any withdrawal symptoms on the second day, the daily buprenorphine/naloxone dose is established as equivalent to the total amount of buprenorphine/naloxone (or buprenorphine) that was administered on the first day. 

Doses may be subsequently increased in 2/0.5 to 4/1 mg increments each day, if needed for symptomatic relief, with a target dose of 12/3 to 16/4 mg per day to be achieved within the first week, unless side effects occur. If side effects occur, the dose of buprenorphine should be maintained or lowered until these side effects disappear.

Patients who return on Day 2 experiencing withdrawal symptoms should receive an initial dose of buprenorphine/naloxone equivalent to the total amount of buprenorphine/naloxone (or buprenorphine) administered on Day 1 plus an additional 4/1 mg (maximum initial dose of 12/3 mg). If withdrawal symptoms are still present 2 hours after the dose, an additional 4/1 mg dose can be administered. The total dose on Day 2 should not exceed 16/4 mg. Continue dose increases on subsequent days according to the induction schedule up to a maximum of 32/8 mg per day.

If  patients  have  problems  adjusting  to buprenorphine (e.g., experience withdrawal symptoms or continue to feel compelled to use illicit drugs), the dose may need to be increased more rapidly, or to a higher maintenance dose level, and patients may need intensive psychosocial treatments to help them cease illicit use. Patients who continue to take illicit opioids should be warned strongly of the dangers of continuing to do so.

 Physicians also should verify that patients are taking the medication correctly and should assess the timing of doses in relation to last opioid use, amount of time the medication is allowed to dissolve under the tongue, and dose taken. If a dose of buprenorphine makes a patient feel worse, it is likely that the medication is causing precipitated withdrawal. In this situation, the physician should help the patient to decrease the use of the illicit opioid while gradually increasing the dose of buprenorphine. Toxicology testing for drugs of abuse may be helpful in determining adequacy of clinical response. 

References: Clinical Guidelines For The Use of Buprenorphine in the Treatment of Opioid Addiction (TIP 40) Chapter 4 

Compiled And Edited By: Deborah Shrira   Updated: 4 April 2007

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