Methadone (Methadone Hydrochloride) - Summary

METHADONE SUMMARY

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

Alcohol 8%

Methadone hydrochloride acts as a narcotic analgesic.

See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Methadone

Hepatitis C Screening Of Mothers Using Methadone And Their Babies Is Inadequate, Australia
Source: Liver Disease / Hepatitis News From Medical News Today [2009.11.16]
Screening for Hepatitis C virus (HCV) infection among pregnant women on methadone maintenance treatment and their infants is inadequate, according to the authors of a study published in the Medical Journal of Australia. Dr Ralph Nanan, Professor of Paediatrics at the University of Sydney, and his co-authors undertook a retrospective review of medical records from two major hospitals in Sydney and a hospital in rural NSW.

more news >>

Published Studies Related to Methadone

Cocaine vaccine for the treatment of cocaine dependence in methadone-maintained patients: a randomized, double-blind, placebo-controlled efficacy trial. [2009.10]
CONTEXT: Cocaine dependence, which affects 2.5 million Americans annually, has no US Food and Drug Administration-approved pharmacotherapy. OBJECTIVES: To evaluate the immunogenicity, safety, and efficacy of a novel cocaine vaccine to treat cocaine dependence... CONCLUSIONS: Attaining high (>or=43 microg/mL) IgG anticocaine antibody levels was associated with significantly reduced cocaine use, but only 38% of the vaccinated subjects attained these IgG levels and they had only 2 months of adequate cocaine blockade. Thus, we need improved vaccines and boosters. Trial Registration clinicaltrials.gov Identifier: NCT00142857.

Rationale, design, and sample characteristics of a randomized controlled trial of directly observed antiretroviral therapy delivered in methadone clinics. [2009.09]
BACKGROUND: Directly observed therapy (DOT) programs for HIV treatment have demonstrated feasibility, acceptability, and improved viral suppression, but few have been rigorously tested. We describe a randomized controlled trial testing the efficacy of an antiretroviral DOT program in methadone maintenance clinics. Our objective was to determine if DOT is more efficacious than self-administered antiretroviral therapy for reducing HIV viral load, improving adherence, and reducing drug resistance among opioid dependent drug users receiving methadone treatment... CONCLUSIONS: Our trial will allow rigorous evaluation of the efficacy of directly observed antiretroviral therapy delivered in methadone clinics for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among HIV-infected drug users receiving methadone for opioid dependence.

Diacetylmorphine versus methadone for the treatment of opioid addiction. [2009.08.20]
BACKGROUND: Studies in Europe have suggested that injectable diacetylmorphine, the active ingredient in heroin, can be an effective adjunctive treatment for chronic, relapsing opioid dependence... CONCLUSIONS: Injectable diacetylmorphine was more effective than oral methadone. Because of a risk of overdoses and seizures, diacetylmorphine maintenance therapy should be delivered in settings where prompt medical intervention is available. (ClinicalTrials.gov number, NCT00175357.) 2009 Massachusetts Medical Society

Interim methadone treatment: impact on arrests. [2009.08.01]
AIMS: This study examines the frequency and severity of arrest charges among heroin addicts randomly assigned to either interim methadone (IM) maintenance or to remain on a waiting list for methadone treatment. It was hypothesized that IM participants would have a: (1) lower number of arrests at 6 and 12 months and (2) lower mean crime severity scores at 6 and 12 months post-baseline... CONCLUSIONS: IM as compared to the waiting list condition, had a significant reduction in number of officially recorded arrests from baseline to 6 months post-baseline. Those who were enrolled in methadone treatment at the 4- and 10-month follow-up assessment, regardless of initial assignment, had fewer arrests at 12 and 24 months post-baseline.

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project Study: protocol for a randomised controlled trial comparing methadone and buprenorphine for opiate detoxification. [2009.07.14]
BACKGROUND: In the United Kingdom (UK), there is an extensive market for the class 'A' drug heroin and many heroin users spend time in prison. People addicted to heroin often require prescribed medication when attempting to cease their drug use... Secondary outcomes will be recorded during the detoxification and then at one, three and six months post-detoxification.

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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 data.

Methadone Effects on Zidovudine (ZDV, AZT) Disposition [Completed]
To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists.

Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone [Active, not recruiting]
To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole.

Injection drug users constitute the second largest subset of the U. S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.

A Study of Azidothymidine Plus Methadone in Patients With AIDS and AIDS Related Complex (ARC) [Completed]
To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT.

The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.

Interactions of HIV Protease Inhibitors and Methadone in HIV-Infected Patients [Completed]
The purpose of this study is to see if it is safe to combine methadone with two HIV protease inhibitors (PIs), ritonavir (RTV) and saquinavir (SQV), in HIV-infected patients not currently taking PIs. This study will measure the interactions between methadone and the PIs.

Methadone is used treat addicts and to treat severe pain. In order to find the safest way to use methadone with PIs, it is important to evaluate how they interact.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

Methadone review by 53 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Back pain
Dosage & duration:		50 mg daily taken everyday for the period of 7 years
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		Methadone certainly took care of the back pain I was experiencing. It was better than the other pain meds I tried (vicodin, oxycontin, percocet). The methadone doesn't make me drowsy nor does it give me "buzz".
Side effects:		The side effects is weight gain. As it was explained to me, the methadone slows down your metabolism, hence the weight gain.
Comments:		I had scoliosis and also landed on my head in a dirt bike riding accident.I had back and neck surgery. I was fused in my last three vertebrae and had a 14" rod implanted on the left side of my back and also one of the vertebrae in my neck was fused. I had physical therapy and was given methadone for the pain.

Methadone review by 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		addiction
Dosage & duration:		150 mg a day now on 105 mg after 7 years taken 150 mg. once a day for the period of seven years so far...
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The benefits was getting off of drugs. I go to a methadone clinic and i PAY $13 a day and i have for the last seven years. It helped me get off of Oxycotin's, but i would NOT recommend staying on it for long.. Because methadone is more addictive than pain pills.
Side effects:		passing out; falling asleep drowsiness, weight gain when i first started i had alot of nausea, but after a few months it was better.
Comments:		When i first started going to the methadone clinic, i had to go there withdrawing. I had to take a physical and a drug test when i started. You can fail the first test, because they know you would have drugs in your system. I had to pay $154 when i first started and i pay almost $400 a month, which equals out to be $13.50 a day. I get drug tested every month and i have passed so many that i get "take homes". I only have to go there once a month now and i have to see my counslor for an hour each month and get drug tested. I get called in for random drug testing. I have to bring my bottles in so they will know that they are "straight" so they know i am not selling them. They do that to everyone. I have been there for seven years now and i am 26 years old. WHen i first started, i had to drive 1 1/2 hours a day for seven days a week for three months and then i got one take home. after three months of passing drug tests: 1 take home 6 months: 3 take homes one year: 5 take homes 1 1/2 years: a weeks worth 2 years: 2 weeks worth 2 1/2 years: a months worth.... I had to drive so much where there isn't many clinics in the states and i had to drive that far just to get to mine. I have been doing good and being strong. I just wish i would have lowered myself down after about 6 months. So now i am addicted to methadone. It is just legal and cheaper for me then pills and i know i get it everyday. I hope i helped. Thanks. :)

Methadone review by 26 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		addiction
Dosage & duration:		150 mg a day now on 105 mg after 7 years taken 150 mg. once a day for the period of seven years so far...
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The benefits was getting off of drugs. I go to a methadone clinic and i PAY $13 a day and i have for the last seven years. It helped me get off of Oxycotin's, but i would NOT recommend staying on it for long.. Because methadone is more addictive than pain pills.
Side effects:		passing out; falling asleep drowsiness, weight gain when i first started i had alot of nausea, but after a few months it was better.
Comments:		When i first started going to the methadone clinic, i had to go there withdrawing. I had to take a physical and a drug test when i started. You can fail the first test, because they know you would have drugs in your system. I had to pay $154 when i first started and i pay almost $400 a month, which equals out to be $13.50 a day. I get drug tested every month and i have passed so many that i get "take homes". I only have to go there once a month now and i have to see my counslor for an hour each month and get drug tested. I get called in for random drug testing. I have to bring my bottles in so they will know that they are "straight" so they know i am not selling them. They do that to everyone. I have been there for seven years now and i am 26 years old. WHen i first started, i had to drive 1 1/2 hours a day for seven days a week for three months and then i got one take home. after three months of passing drug tests: 1 take home 6 months: 3 take homes one year: 5 take homes 1 1/2 years: a weeks worth 2 years: 2 weeks worth 2 1/2 years: a months worth.... I had to drive so much where there isn't many clinics in the states and i had to drive that far just to get to mine. I have been doing good and being strong. I just wish i would have lowered myself down after about 6 months. So now i am addicted to methadone. It is just legal and cheaper for me then pills and i know i get it everyday. I hope i helped. Thanks. :)