If methadone is administered for treatment of heroin dependence for more than 3 weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his/her stay or whose enrollment has been verified in a program approved for maintenance treatment with methadone.
METHADONE HYDROCHLORIDE TABLETS, USP
5 mg, 10 mg
CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS:
Code of Federal Regulations, Title 21, Sec. 291.505
METHADONE PRODUCTS, WHEN USED FOR TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY.
APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505).
FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM.
A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY.
Each 5 mL of solution for oral administration contains:
Methadone Hydrochloride.............. 5 mg or 10 mg
Methadone hydrochloride acts as a narcotic analgesic.
Media Articles Related to Methadone
EU Agency Endorses Suspension of Oral Methadone Products
Source: Medscape Psychiatry & Mental Health Headlines [2014.07.24]
An EU regulatory agency has officially endorsed recommendations to suspend methadone oral solutions that contain high-molecular-weight povidone.
Medscape Medical News
Published Studies Related to Methadone
Tramadol versus methadone for treatment of opiate withdrawal: a double-blind,
randomized, clinical trial. 
The aim of this study was to compare the efficacy and safety of tramadol versus
methadone for treatment of opiate withdrawal. Seventy patients randomly were
assigned in two groups to receive either prescribed methadone (60 mg/day) or
tramadol (600 mg/day)... Tramadol may be as effective as methadone in the
control of withdrawal and could be considered as a potential substitute for
methadone to manage opioids withdrawal.
Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics. [2011.11.12]
ABSTRACT: BACKGROUND: Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment...
Randomized Trial of Standard Methadone Treatment Compared to Initiating Methadone without Counseling: 12-month Findings. [2011.10.26]
Aims: This study aimed to determine the relative effectiveness of 12-months of Interim Methadone (IM; supervised methadone with emergency counseling only for the first 4 months of treatment), Standard Methadone treatment (SM; with routine counseling) and Restored Methadone treatment (RM: routine counseling with smaller caseloads)...
Trazodone for sleep disturbance during methadone maintenance: A double-blind, placebo-controlled trial. [2011.07.26]
BACKGROUND: To test whether trazodone, one of the most commonly prescribed medications for treatment of insomnia, improves subjective and/or objective sleep among methadone-maintained persons with sleep complaints, we performed a randomized, double-blind, placebo-controlled trial with 6-month follow-up... CONCLUSIONS: Trazodone did not improve subjective or objective sleep in methadone-maintained persons with sleep disturbance. Other pharmacologic and non-pharmacologic treatments should be investigated for this population with high rates of insomnia. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency. [2011.07.26]
BACKGROUND: Substitution with opioid-agonists (e.g., methadone) has shown to be an effective treatment for chronic long-term opioid dependency. Patient satisfaction with treatment has been associated with improved addiction treatment outcomes. However, there is a paucity of studies evaluating patients' satisfaction with Opioid Substitution Treatment (OST). In the present study, participants' satisfaction with OST was evaluated at 3 and 12 months. We sought to test the relationship between satisfaction and patients' characteristics, the treatment modality received and treatment outcomes... CONCLUSIONS: The higher satisfaction among those receiving medically prescribed injectable diacetylmorphine (or hydromorphone) supports current evidence regarding the attractiveness of this treatment for long-term, opioid-dependent individuals not benefiting sufficiently from other treatments. In addition, the measurement of treatment satisfaction provides valuable information about participants at risk of relapse and in need of additional services. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00175357.
Clinical Trials Related to Methadone
Co-Administration Of Fosamprenavir With Methadone: A Drug Interaction Study. [Completed]
To assess the combined effects of fosamprenavir 700mg BID + ritonavir 100mg BID +
standardized dose of methadone, on plasma total and unbound methadone enantiomer
pharmacokinetics (PK), opiate pharmacodynamic (PD) measures, and safety. The effect of
methadone on plasma amprenavir PK will also be assessed by comparison to historical control
Methadone Pharmacokinetics and Cardiac Effects in Newborns [Recruiting]
The Primary objectives of this proposal are to determine the population kinetics for
methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post
menstrual age (PMA) who are 1 week old and older and establish any correlations of the
kinetics with PMA to determine the bioavailability for enterally administered methadone in
these newborns and young infants.
The secondary objectives of this proposal are to explore possible genotypic changes in
CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in
neonates and young infants and to test the safety of methadone in this population by
correlating the plasma concentrations of the methadone enantiomers, S-methadone and
R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart
rate, and blood pressure.
Drug Interaction Study Of Filibuvir With Methadone, Among Subjects On Chronic Methadone Maintenance [Not yet recruiting]
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C
infection. Given the likelihood of co administration of filibuvir and methadone, this study
will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
Methadone Maintenance & HIV Risk in Ukraine [Recruiting]
Treatment of opioid dependence is an important way to reduce the spread of HIV and other
infectious diseases, particularly in Ukraine since intravenous opioid use is the major way
these infections are being spread. This proposal will be done at the Kiev City Narcology
Hospital and the City AIDS Center with collaborators from the University of Alabama and the
University of Colorado. It will study the acceptability and impact of a 3-month course of
methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-.
The proposed work will build on a relationship that was established with the Ukrainian
Co-Principal Investigator, Sergiy Dvoryak, M. D., during his Humphrey Fellowship at Johns
Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and
Treatment and Research Center. It will also extend studies of pharmacologic treatment for
opioid dependence and risk reduction behavioral interventions that are being done by Drs.
Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the
acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV-
patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+
and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk
behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a
3-month course of methadone maintenance reduces illegal activities and improves employment
and psychiatric symptoms; determine short-term outcome after completion of methadone
treatment; and obtain pilot data on the prevalence of hepatitis B and C among study
patients. This study will provide pilot data on the acceptability and efficacy of a
short-term course of methadone maintenance on HIV+ and HIV- persons in a setting where this
treatment has not been evaluated, on the feasibility of conducting the kind of work that is
proposed, and will enhance research capabilities of Kiev investigators for future HIV
prevention and treatment studies.
Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study. [Not yet recruiting]
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
clinical development for the treatment of HIV infection. As HIV-infected subjects may also
be receiving methadone for opioid dependence, an evaluation of the potential interaction
between DTG and methadone is warranted. The primary objective of this study is to determine
whether concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone.
As a secondary endpoint, the PK of DTG will be compared to historical data. This study
will be open-label with subjects receiving DTG and stable doses of methadone. The study
will be conducted at one center in Canada in adult male and female subjects.
Reports of Suspected Methadone Side Effects
Respiratory Arrest (10),
Cardiac Arrest (10),
Drug Abuse (7),
Completed Suicide (6),
Drug Ineffective (3),
Toxicity TO Various Agents (3),
Escherichia Sepsis (2), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 8 ratings/reviews, Methadone has an overall score of 8.25. The effectiveness score is 10 and the side effect score is 6.75. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Methadone review by 35 year old male patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || OPIATE ADDICTION|
|Dosage & duration:|| || 10MG taken daily for the period of ONE YEAR|
|Other conditions:|| || NONE|
|Other drugs taken:|| || NONE|
|Benefits:|| || I had tesiticular cancer, and I became addicted to OxyContin. Try as I did, I simply could not kick the habit. Methadone really worked for me, and after a while, I tapered at a slow rate.|
|Side effects:|| || None.|
|Comments:|| || Ten Miligrams daily. Of course, at first you have to deal wiht the clinic, but take-home doses are easy to earn as long as you're doing what you're supposed to be doing.|
Methadone review by 40 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || drug addiction|
|Dosage & duration:|| || 130 mg taken daily for the period of 7 yrs|
|Other conditions:|| || asthma, high blood pressure, diabetes|
|Other drugs taken:|| || metfromin, inhalers, |
|Benefits:|| || I was able to control my addiction and not have to depend on pills to get through the day|
|Side effects:|| || falling asleep anywhere |
|Comments:|| || i started off taking approx 130mg in about 7 yrs and have now reached 65mg in my 8th yr off taking methadone. it has helped me to be a normal person again and no spend my day trying to find the next pill.|
Methadone review by 26 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || opiod addiction|
|Dosage & duration:|| || 60mg/day taken daily for the period of monthly|
|Other conditions:|| || back pain|
|Other drugs taken:|| || none|
|Benefits:|| || It worked but then I became addicted to methadone so basically it just traded one addiction for another. I don't take as many Methedone a day as I did pain pills because Methadone is long lasting so I guess it did help me.|
|Side effects:|| || At first I got painful headaches but that subsided after continued use. I do still have horrible constipation and I have sexual dsyfuntion.|
|Comments:|| || I began recieving Methadone when I was 21 years old. I started seeing a pschiatrist because I needed help for pain pill addiction. I began getting prescriptions for hydrocodone when I was 19. I have an abnormality in my lower back which causes me severe pain. I began taking more than I was supposed to for the pain and was taking anywhere from 20 to 30 pain pills a day. So I knew I needed help. That's when my doctor gave me Methadone. He gave me 60mg a day but I usually only took 40mg depending on what I needed. Over the years I have weaned myself down to 20mg a day and everyone even my doctor says to me that I should be able to come off of these pills easily but no one understands the physical and psychological symptoms I go through. It's so hard to just stop taking them when I have became so depended on them in my daily life. I have four kids and with out them I feel like a different person and it takes everything in me to get out of bed and take care of my kids. Is it in my head? I don't know but either way, in a lot of ways it helped me but in a lot of ways it ruined my life. I don't want to be addicted to a pill for the rest of my life. Now my doctor has stopped giving them to me because he feels that I can come off them easily at such a low dose but what does he know he does not understand what it feels like. I am at such a downfall in my life, I have to buy them now just to feel normal every day. I feel like if these doctors give them to me then they should help me with the withdrawals ao I can get off them. I still need help after all these yesrs. I don't have a car to drive to a methadone clinic everyday and no one to help me. So what are people like me to do?|
Page last updated: 2014-07-24