Medication Assisted Treatment - OTP's

Aspects of Recovery: Medication Assisted Treatment-OTP’s

For more than 50 years, methadone has been proven time and time again as the most effective treatment for individuals afflicted with the disease of an opioid use disorder, or opioid addiction. Its safety and effectiveness can be found in countless research studies around the world.

Methadone is a synthetic opioid medication that can be used to treat chronic pain, but it is primarily utilized in treating opioid addiction. Methadone is regulated by the DEA and is only administered for addiction treatment through an approved opioid treatment program (OTP). Methadone is a full agonist opioid meaning that it acts similarly to other opioids by fully activating the receptors in the brain.

Methadone attaches fully to the opioid receptors in the brain, and at an appropriate dose, does not create the euphoria or “high” illicit opioids create. It eliminates the physical withdrawal symptoms felt when opioids are no longer present in the system of the individual using the drugs. This is critical in controlling the cravings that cause relapse early in recovery for so many.

When withdrawals and cravings are controlled, individuals can focus on treatment for addiction and repairing the damage done to their lives. Additionally, methadone has some opioid blocking properties, limiting the effect of other opioids used while methadone is present.

Methadone maintenance has been demonstrated repeatedly to be safe and effective when used with appropriate safeguards and psychosocial services. Maintenance treatment typically leads to reduction or cessation of illicit opioid use and its adverse consequences, including cellulitis, hepatitis, and HIV infection from use of non-sterile injection equipment, as well as criminal behavior associated with obtaining drugs.

Methadone is an opioid, like heroin or opium. Methadone maintenance treatment has been used to treat opioid dependence since the 1950s. The opioid-dependent patient takes a daily dose of methadone as a liquid or pill. This reduces their withdrawal symptoms and cravings for opioids.

Methadone is addictive, like other opioids. However, being on methadone is not the same as being dependent on illegal opioids such as heroin:

  • It is safer for the patient to take methadone under medical supervision than it is to take heroin of unknown purity.

  • Methadone is taken orally. Heroin is often injected, which can lead to HIV transmission if needles and syringes are shared.

  • People who are heroin-dependent often spend most of their time trying to obtain and use heroin. This can involve criminal activity such as stealing. Patients in methadone do not need to do this. Instead, they can undertake productive activities such as education, employment, and parenting.

Methadone has been included on the World Health Organization’s List of Essential Medicines. This highlights its importance as a treatment for heroin dependence.

There has been a great deal of research on Methadone Maintenance Therapy (MMT). This research has found that:

  • MMT significantly reduces drug injecting because it reduces drug injecting, MMT reduces HIV transmission

  • MMT significantly reduces the death rate associated with opioid dependence;

  • MMT reduces criminal activity by opioid users and

  • Methadone doses of greater than 60 mg are most effective.

It has also been shown that patients receiving methadone doses of greater than 60 mg per day were less likely to use or inject drugs than patients receiving doses of less than 60mg per day.

Effects of methadone

Methadone is a synthetic opioid agonist. This means it produces effects in the body in the same way as heroin, morphine, and other opioids. It is taken orally as a tablet or syrup.

When an opioid-dependent person takes methadone, it relieves withdrawal symptoms and opioid cravings; at a maintenance dose, it does not induce euphoria.

The onset of effects occurs 30 minutes after swallowing and peak effects are felt approximately three hours after swallowing. At first, the half-life (the length of time for which effects are felt) of methadone is approximately 15 hours; however, with repeated dosing, the half-life extends to approximately 24 hours. It can take between 3 and 10 days for the amount of methadone in the patient’s system to stabilize.

Most people beginning MMT experience few side effects. However, there are some side effects of methadone, including:

  • Disturbed sleep

  • Nausea and vomiting

  • Constipation

  • Dry mouth

  • Increased perspiration

  • Sexual dysfunction

  • Menstrual irregularities in women

  • Weight gain

Interactions between methadone and other medications

Interactions between methadone and other drugs can lead to overdose or death.  Drugs that depress the respiratory system (e.g. benzodiazepines) increase the effects of methadone or affect metabolism can induce methadone withdrawal symptoms:

Drug

Effect

Alcohol   

Increased sedation and respiratory depression

Barbiturates  

Reduce levels, increased sedation, and respiratory depression

Benzodiazepines  

Increased sedation and respiratory depression

Buprenorphine 

Increased sedation and respiratory depression OR antagonist effect

Carbamazepine 

Reduced methadone levels

Chloral hydrate 

Increased sedation and respiratory depression

Chlormethiazole 

Increased sedation and respiratory depression

Cyclazine et al

May cause hallucinations

Desipramine  

Increased desipramine levels

Fluoxetine 

Increased methadone levels

SSRI’s et al

Increased methadone levels

Ketoconazole 

Increased methadone levels

Meprobamate 

Increased sedation and respiratory depression

Naltrexone 

Blocks the effects of methadone (long-acting)

Naloxone

Blocks the effects of methadone  (may be required in case of opioid overdose)

Nevirapine et al 

Decreased methadone levels

Phenytoin 

Decreased methadone levels

Rifampicin

Decreased methadone levels

Rifabutin

Decreased methadone levels

Ritonavir et al

Decreased methadone levels

Thioridazine 

Increased sedation and respiratory depression

Ascorbic acid 

Decreased methadone levels

Sodium bicarbonate

Increased methadone levels

Zidovudine 

Increased Zidovudine levels – the risk of anemia

Zopiclone 

Increased sedation and respiratory depression

Opioid agonists 

Increased sedation and respiratory depression

CNS 

Increased sedation and respiratory depression

Methadone-medication interactions.

  • The HIV medications nevirapine and efavirenz increase the metabolism of methadone, causing opioid withdrawal. Some protease inhibitors (PIs) may have the same effect, especially when associated with a small boosting dose of ritonavir.

  • The tuberculosis medication rifampicin increases the metabolism of methadone and reduces the half-life of methadone.

Patients receiving these medications, or other medications in combination with methadone should be monitored for signs of withdrawal or intoxication, and their methadone dose adjusted accordingly.

See also AIDSinfo, http://www.hivatis.org/, for up-to-date listings of anti-retroviral medications and interactions with other drugs.

Patients in methadone maintenance treatment can become tolerant to the pain-relieving effects of opioids. In the event that an MMT patient requires pain relief, non-opioid analgesics such as paracetamol can be given. If methadone patients are provided with opioid analgesics, they may require higher than normal doses to experience pain relief.

ENTERING TREATMENT

Methadone maintenance treatment is indicated for patients who are dependent on opioids or have a history of opioid dependence. In closed settings, it is important to remember that patients not currently physically dependent on opioids can benefit from the relapse prevention effects of methadone maintenance treatment.

Patients must also be able to give informed consent for methadone maintenance treatment.

Contraindications

Patients with severe liver disease should not be prescribed methadone maintenance treatment as methadone may precipitate hepatic encephalopathy.

Patients who are intolerant of methadone or ingredients in methadone formulations should not be prescribed methadone.

Priority patients

Patients who meet any of the following criteria should commence MMT without delay:

  • HIV positive

  • Receiving treatment for HIV or hepatitis C

  • Patients who have been on community methadone maintenance treatment programs. In these cases, the patient should continue MMT in the closed setting at the dose that they were receiving in the community. It is very important that the patient’s treatment is not interrupted unnecessarily; hence, the closed setting should have a procedure in place for people who are detained while on methadone.

  • History of a drug overdose in closed settings

  • History of self-harm/suicidal behavior in relation to opioid dependence

  • Pregnant, opioid-dependent women should commence methadone maintenance treatment as soon as possible. Pregnant women should be assessed and dosed in the same manner as other patients. Should a patient fall pregnant while in MMT, she can be maintained on her usual daily dose? In the last trimester of pregnancy, it may be necessary to increase the daily dose in order to adequately control withdrawal symptoms. Babies born to mothers on methadone maintenance treatment may experience withdrawal syndrome, which should be managed by a postnatal care specialist.

Risks and precautions

There are few risks associated with the long-term use of methadone. Methadone does not damage any of the major organs or systems of the body. There are few side effects of methadone and those that do occur are less harmful than the risks associated with illicit opioid use.

Overdose

The major risk associated with methadone is overdose. Overdose is a particular concern in the initial stages of MMT and when methadone is used in combination with other depressant drugs. Methadone overdose may not be obvious for three to four hours after ingestion. Patients should be closely monitored during the first week of treatment for signs of overdose, including:

  • Pinpoint pupils

  • Nausea and vomiting

  • Dizziness

  • Excess sedation

  • Slurred speech

  • Snoring

  • Slow pulse and shallow breathing

  • Frothing at the mouth

  • Unconscious and unable to be roused

Overdose is more likely to occur if the patient is using other drugs that depress the central nervous system e.g. alcohol, benzodiazepines, or opioids. Patients should be informed of the risks of using these drugs in combination with methadone.

In case of overdose, naloxone should be administered. This reverses the effects of methadone. Because methadone has a long half-life, it is necessary to provide a prolonged infusion or multiple doses of naloxone over several hours. Patients who have overdosed should be transferred to a hospital and monitored for at least four hours.

Ongoing poly-drug use

Methadone should be prescribed with caution to patients who are using other drugs, particularly those that depress the central nervous system (e.g. alcohol, benzodiazepines). Patients should be advised of the increased risk of overdose associated with using methadone in combination with other drugs.

Concurrent medical problems

Methadone should be prescribed with caution in patients with:

  • Asthma and other respiratory conditions

  • Hypothyroidism

  • Adrenocortical insufficiency

  • Hypopituitarism

  • Prostatic hypertrophy

  • Urethral stricture

  • Diabetes Mellitus

Informed consent and treatment planning

Before beginning MMT, the patient must be given enough information for him or her to make an informed decision about commencing treatment. The patient should be told:

  • The rationale for methadone maintenance treatment

  • The reasons it has been recommended to treat their opioid dependence

  • Side effects and risks of treatment

  • Expected length of treatment

  • Other treatment options

As part of informed consent, the patient should be told about the rules that must be followed to receive methadone treatment. For example:

  • Patients consume their complete dose in front of dosing staff and do not give or sell any part of their dose to others.

  • No violence or threats of violence against staff or other patients

  • The patient is to attend consultations with their doctor as required

  • Consequences for breaching these rules

The patient should be given a patient information statement containing all of the above information and asked to read it. If the patient cannot read, the patient information statement should be read aloud. 

After obtaining informed consent from the patient, a treatment plan is developed that outlines the patient’s starting dose and the schedule by which doses will increase. 

Initial Dosing

The first dose of methadone given to a patient is low. The size of the dose is gradually increased until the maintenance dose is reached. The maintenance dose is the amount of methadone the patient requires to prevent opioid withdrawal symptoms but does not induce euphoria.

  • The first dose of methadone should be between 10-30 mg. Patients who have recently used opioids can be given the first dose at the higher end of this range. The first dose given to a patient who has not recently used opioids should be no greater than 10-20 mg. 

  • Observe the patient 3-4 hours after the first dose has been taken. If the patient is showing signs of overdose, continue to monitor the patient at fifteen-minute intervals. If the patient enters a coma, administer naloxone as a prolonged infusion.  

  • If there is no relief at 3 hours after the initial dose, and the initial dose is less than 25 mg, a patient may receive a supplemental dose of 5 – 10 mg, not to exceed a total of 30 mg on the first day.  

  • Provide the same dose daily for three days if the patient has relief from symptoms at 3 hours.

The patient will experience increasing effects from the same dose over this time. After the first three days, assess the patient’s withdrawal symptoms. If the patient is experiencing withdrawal, increase the dose by 5-10mg every three days. Dose increases should not be greater than 20 mg per week.

Monitor the patient for signs of withdrawal and intoxication and adjust the methadone dose accordingly to find the patient’s maintenance dose. This process may take several weeks. The maintenance dose will usually be between 60-120 mg but may be higher or lower, depending on the patient’s history of opioid use.

Patients who have been treated with buprenorphine

If a patient is detained who has been on buprenorphine maintenance treatment in the community, the patient should continue this treatment. However, if buprenorphine is not available, or the patient’s tolerance is such that buprenorphine does not offer relief from symptoms of withdrawal, the patient should be transferred to methadone maintenance treatment 

Methadone is a medicine used to treat heroin dependence. It is taken daily to relieve heroin withdrawal symptoms and reduce cravings for heroin. The aim of methadone maintenance treatment is to help reduce illicit drug use by relieving symptoms of withdrawal.  Before beginning methadone maintenance treatment, be aware of the following:

  • Methadone is an opioid, like heroin. While in this treatment, you will still be dependent on opioids. But, taking methadone will be much safer than taking heroin. Taking methadone can give you a break from the drug-using lifestyle and give you a chance to work on any social, financial, or family problems you are having as a result of your drug use.

  • Methadone maintenance treatment is a long-term treatment. Some people receive methadone for many months or even years. While in methadone maintenance treatment, you will need to attend the clinic once a day to receive your dose of medicine.  Over time and on a federal standard schedule, patients are able to have ‘take home’ medication privileges if

    • meet guidelines for a time in treatment​

    • are on a stable dose level of medication

    • absence of other illicit substances

    • are engaged in treatment as evidenced through no absences

    • meet criteria to secure medications safely

    • absence of illegal behaviors or aggression as outlined in clinic rules and policy

    • demonstrate financial stability

    • meet another clinic, state, and federal guidelines

  • Tell your doctor and the clinic doctor if you are taking any other medications or herbal remedies as these may interact with methadone, causing health problems.

  • Some people experience side effects from taking methadone. These include constipation, nausea, feeling tired, perspiring more than usual, a dry mouth, and feeling dizzy.

  • If you begin methadone maintenance treatment, you must avoid taking other opioids such as heroin, codeine, morphine or opium. Taking these drugs in combination with methadone can lead to overdose, which can be fatal. If you drink alcohol, be sure to do so in moderation, as alcohol and methadone in combination can also lead to overdose.

  • There are other drug treatment options available besides methadone maintenance treatment. Ask your doctor if you would like to know about these.

Should you begin methadone maintenance treatment at this clinic, you will be required to follow these rules:

  • You must attend for dosing each day.

  • You must attend treatment review sessions with the medical director regularly.

  • You must not sell or give your methadone dose to anyone else. Your dose has been determined based on your level of opioid dependence. Other people may overdose if you sell or give them your dose. If you are being bullied or forced to give your dose to someone, tell a staff member of the clinic.

  • You must not engage in any threatening or violent behavior towards staff or other patients, or you will be removed from the treatment program.

MANAGEMENT OF DOSING

Patients in methadone maintenance treatment must be dosed once every day. Methadone dosing must be strictly managed in order to minimize diversion. Diversion refers to patients giving or selling their methadone to others for other’s use:

  • A patient may deliberately not swallow, or swallow and then vomit, their dose in order to sell it or give it to another resident

  • A patient may be forced by another resident to give their dose away

A well-managed program can minimize the risk of diversion by having clear dosing procedures, such as provided below, that are strictly followed.

Requests for dose increases

Patients who request a dose increase should be provided with their prescribed dose and referred to the prescribing doctor for review.

Missed doses

Patients are required to attend the clinic daily for dosing unless other special arrangements are made. However, patients may sometimes miss doses. They may choose not to attend for dosing or may miss dosing through no fault of their own.

A suggested schedule for dosing patients who have missed doses is provided by the facility and is federally monitored. In all cases, staff should consult with patients as to why they did not present for dosing, as you may be able to assist the patient in resolving problems that have prevented them from attending the clinic.

Vomited doses

Sometimes, patients may vomit their dose before it is absorbed into the body. There are federal guidelines the clinic must follow on re-dosing patients who have vomited. The clinic should have these posted or provide to the patient upon request.

Treatment review

At regular periods, the patient and prescribing doctor should meet for a treatment review. The following should be discussed at a treatment review:

  • Suitability of the current methadone dose, withdrawal symptoms and side effects, requests for dose increases

  • Other medications the patient is taking

  • Physical and psychological health

  • Current drug use, including signs of injecting drug use

  • Review of treatment goals

At the commencement of MMT, treatment review should occur weekly. After two months in treatment, the frequency of treatment reviews can be reduced to once every four to six weeks.

Patients who are using illicit drugs are suspected of diverting their methadone dose, or have recently had their dose increased or decreased should attend treatment review meetings weekly.

Urine drug screening

Analysis of a patient’s urine for evidence of illicit drug use is expensive and will not stop patients from using other drugs. Furthermore, results can be unreliable. There is no evidence that punishing patients for returning positive urine samples results in decreased illicit drug use. Urine drug screening should only be used for therapeutic purposes, for example, when a patient is suspected of using drugs, and confirmation of this is required. This provides information that the doctor can use to identify if the patient’s treatment needs are being met. For example, if a patient’s urine sample shows continued heroin use despite being in MMT, it may be a sign that the patient needs a higher methadone dose.

Note:  Most states require at minimum a monthly drug screen using a toxicology lab; a positive test result must be confirmed using an alternate testing method, such as GCMS.  This is also a requirement for Take-Home dose privileges.  

Treatment duration

There is no set rule for how long someone should stay in methadone maintenance treatment. However, it is well known that the longer a patient remains in treatment, the better the outcome. Generally, patients should be encouraged to remain in methadone maintenance treatment for the length of their detention, and then provided with assistance to continue with treatment after release from detention.

An estimated time of treatment for heroin dependency treated with methadone is between 2-4 years, allowing 6 months for induction, time for stabilization and treatment, followed by a medically monitored detox from methadone.  

Additional treatments

All patients should be encouraged to access additional treatments such as psychosocial interventions. However, they should not be mandatory. Counselling and similar treatments are more effective if they are entered into voluntarily.

OTP (Opioid Treatment Programs) that dispense methadone must offer substance abuse counseling and for most clinics nationwide this is a requirement of medicating.  Methadone is not permitted, at this time, to be dispensed by physicians for addiction unless the clinic is designated as an OTP.  

Release planning for methadone patients

It is recommended that all patients receiving MMT in closed settings (jail) be assisted to transfer to a community-based MMT program to continue treatment. Remaining in MMT in the community will help the patient to avoid illicit drug use and HIV risk behaviors such as sharing syringes. It will also reduce the likelihood of drug overdose. Arrangements for transferring the patient’s prescription should be made by the prescribing doctor several weeks before the patient is due for release, in order to allow time for the transfer request to be processed. It can be useful to employ a community liaison officer who can assist in arranging transfers between the closed setting and doctors in the local community.

Factors to consider when planning a patient’s release include:

  • Will the patient be living in an area with easy access to a methadone clinic?

  • Will the patient be able to afford methadone treatment? Are government-subsidized treatment places available (e.g. for patients living with HIV)?

  • What other support services can the patient access once released.

Voluntary cessation of treatment

Patients who wish to stop MMT should meet with the medical director and counselor to discuss their treatment options. The doctor should establish why the patient wants to stop MMT. Reasons for wanting to stop MMT may include:

  • The belief that methadone is not appropriate in their case

  • The belief that they no longer need treatment

  • To avoid problems associated with MMT e.g. side-effects, harassment from others to divert dose

  • To be “drug-free” 

Each of these reasons is legitimate, but the medical director should ensure the patient is aware of the benefits of MMT and has made an informed decision to cease treatment. In particular, patients who wish to cease MMT  should be informed of the increased risk of relapse and drug overdose in the weeks.

If a patient chooses to discontinue treatment, their treatment plan should be revised so that they will start receiving lower doses of methadone over a period of time. The patient should be told that this will happen.

Recommended dose reduction schedule:

  • Reduce by 10mg per 1=3 weeks until a dose of 40 mg per day is reached.

  • From then, reduce by 5mg per week until a zero dose is reached.

  • Dose reductions should occur not less than once a week.

This schedule is a recommendation only. Rates of dose reduction should be discussed with the patient. If the patient is experiencing withdrawal symptoms, it may be appropriate to maintain the patient on a reduced dose for several weeks before recommencing the reduction schedule. Patients should be provided with additional psychosocial support during the dose reduction period.

A patient may begin to reduce his or her dose and later decide that they would prefer to remain in MMT. There should be procedures in place for these patients, and recently discharged patients, to be re-admitted to MMT on request.

Involuntary cessation of treatment

In some situations, it may be necessary to discharge a patient from MMT for the safety of other patients and/or staff. This may be because of violence or verbal abuse towards other patients or staff, or repeated incidents of methadone diversion. Before deciding to remove a patient from MMT, consider that the patient may recommence or increase illicit drug use

Patients who commit minor infractions, for example, illicit drug use or refusal to provide a urine sample, can be disciplined, but should not be made to stop MMT. Methadone doses should never be withheld as punishment to patients. Patients should only be involuntarily removed from the program if their behavior threatens the health and safety of others.

Patients who are made to cease MMT should be placed on the same dose reduction schedule as described for patients voluntarily ceasing treatment. If the patient is considered a serious risk to the safety of staff or other patients, they can be discharged, but this should be reviewed with the entire clinical team and patient.  Efforts to transfer the patient to another facility should be exhausted prior to stopping the medication.  At no point may a patient be refused medication for failure to pay.  May state have a Financial Detox mandate that should be adhered to, varying by state.  Oregon, for instance, is 21 days of decreasing dose level until the level is 1 mg. 

Pregnant patients

Cessation of methadone maintenance treatment during pregnancy is not recommended. Pregnant women should be provided with information about the benefits and risks of methadone during pregnancy. If a woman chooses to stop methadone treatment during pregnancy, it is recommended that dose reductions begin during the second trimester. Dose decreases should be 2.5 to 5 mg per week, and the patient should be closely monitored for signs of withdrawal.  

Many women give birth while on a methadone program without any harm to the infant.  Most babies will be monitored at the hospital for a time to mitigate any withdrawal symptoms they might have.  OTP clinics frequently coordinate care between OB/GYN doctors and clinics to monitor the safety and health of mother and child.  

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