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PubMed1993

Relationship between maternal methadone dosage, maternal-neonatal methadone levels, and neonatal withdrawal.

OBJECTIVE: To define the relationships between neonatal opiate withdrawal and drug-related factors such as maternal methadone dosage, maternal and neonatal plasma levels, and rate of decline of methadone in neonatal plasma. METHODS: Twenty-one methadone-dependent women and their newborn infants were studied. Fourteen of the women used other illicit drugs. The severity of neonatal withdrawal was assessed with a standardized scoring system. Venous blood samples for methadone levels were collected from the mothers within 24 hours of delivery and from their newborns within 24 hours of birth and on day 3-4 of life. RESULTS: The maternal methadone dosage at delivery correlated significantly with the maternal plasma level drawn at 16 hours postpartum (r = 0.512, P < .05), and the maternal methadone level in turn correlated significantly with the neonatal plasma methadone level on day 1 of life (r = 0.545, P < .05). A positive correlation was found between the severity of central nervous system signs of withdrawal and the rate of decline of the neonatal plasma methadone level from day 1 to day 4 of life (r = 0.550, P < .05). CONCLUSION: This spectrum of relationships supports the concept that careful reduction of the maternal methadone dosage during pregnancy under intensive medical and psychosocial surveillance may benefit the drug-exposed new-born infant clinically.

Female↗
PubMed1997

[More of the Surinam and Antilles drug addicts involved in the GG&GD (Community Medical and Health Service) methadone program in Amsterdam should be referred to the family physician for their methadone maintenance].

OBJECTIVE: To study the possibility of referring Surinam and Netherlands Antillean drug users from a 'low-threshold' municipal methadone programme to general practice for methadone maintenance treatment. (Methadone maintenance treatment for drug users leads to a more regulated life and makes it possible to implement measures to ameliorate their living conditions.) Fewer Surinam and Netherlands Antillean drug users are referred to general practice than native Dutch drug users. DESIGN: Descriptive. SETTING: Municipal Health Service, Department of Mental Health, Unit on Drugs, Amsterdam, the Netherlands. METHOD: 141 Surinam and Netherlands Antillean drug users participating in the 'low-threshold' methadone programme were examined on the following items: psychiatric status, drug and alcohol abuse, judicial problems, relationships, personal care, insurance and housing. With these items the level of regulated drug use was assessed and the possible reference to general practice evaluated. RESULTS: 21% of the drugs user group was found to be well regulated. They could have been referred to general practice immediately. Another 18% were also well regulated but they received methadone on a daily basis at the moment of investigation; when they would have proven to manage methadone prescription on a weekly basis, they could also be referred to general practice. 61% could not be referred because they were addicted to benzodiazepines (22%) or alcohol (33%), lived in unsuitable housing (45%), had judicial problems (53%), psychiatric problems (30%) or no insurance (15%), or were very problematic drug users receiving Palfium (dextromoramide) through the 'low-threshold' municipal methadone programme (15%). CONCLUSION: Of Surinam and Netherlands Antillean drug users from a municipal methadone programme, approximately 20% could have been directly referred to general practice for their methadone maintenance treatment and 20% at a later stage, and 60% could not.

Adult↗
PubMed1976

Effects of methadone hydrochloride on the growth of organotypic cerebellar cultures prepared from methadone-tolerant and control rats.

Male and female Sprague-Dawley rats were given dl-methadone (5 mg/kg) for at least 3 months and then mated. The drug was continued throughout pregnancy and after delivery. The newly born pups were divided into two groups. One group was tested for in vivo methadone tolerance, while the animals in the othergroup were used to prepare organotypic cerebellar cultures. Various amounts of dl-methadone were added to the media of half of these cerebellum cultures. The effect of the drug in the medium was assessed by measuring explant outgrowth. Similar experiments were carried out with control animals. Statistical analysis of the data obtained in the in vivo portion of the experiment indicates that the pups of methadone-treated mothers tolerate methadone better than those of untreated mothers. The culture experiments revealed that the addition of methadone to the medium reduced explant outgrowth size and this was a dose-related effect. Also, there was significantly less outgrowth from explants prepared using pups of methadone-treated mothers as compared to the controls. There was no significant difference in the effect of methadone on the growth of cultures prepared from the methadone-tolerant and control animals.

Animals↗
PubMed1994

Methadone levels in plasma, urine, and amniotic fluid of methadone-treated pregnant rats.

Methadone was administered in the form of a slow release emulsion to nonpregnant rats and pregnant animals at early, middle, or late gestation. Following a 48-h treatment period, plasma, urine, and amniotic fluid were analyzed for methadone and its two major metabolites using solid-phase extraction and reversed-phase HPLC. Methadone and its primary metabolite were detected in plasma and urine of all rats with levels of both compounds comparable at all stages of gestation. No significant difference was found for either methadone or its primary metabolite between gestation groups and nonpregnant animals. Amniotic fluid collected in middle and late gestation groups contained methadone and primary metabolite at levels similar to that of maternal plasma. These data show that methadone can be detected in plasma, urine, and amniotic fluid following short-term treatment of pregnant rats with the opiate. Methadone levels did not alter during pregnancy and were, in fact, similar to that of nonpregnant animals. These results indicate that the fetal environment contains methadone levels comparable to that of the maternal circulation.

Amniotic Fluid↗
PubMedDate not supplied

Efficacy of methadone versus methadone and guanfacine in the detoxification of heroin-addicted patients.

In a randomized double-blind study, the clinical efficacy of methadone vs. methadone and guanfacine was assessed in terms of evolution of opioid withdrawal symptoms during inpatient detoxification. A total of 144 patients were included and randomly allocated to three different treatment groups: methadone alone, and two combined treatment schedules (methadone plus 3 or 4 mg of guanfacine). No differences were observed among the three groups with regard to retention rate throughout the study period. Both therapies, methadone and methadone plus guanfacine, determined a slight increase in withdrawal scores when methadone was discontinued. However, guanfacine was unable to effectively control methadone-associated withdrawal symptoms. These results indicate that guanfacine does not effectively reduce the opioid withdrawal symptoms.

Adult↗
PubMed1982

Short-term effects of oral methadone in methadone maintenance subjects.

In two experiments the physiologic and subjective status of methadone maintenance patients was assessed during the presumed peak (0 to 6 hr postmethadone) and during the presumed nadir of the daily methadone effect (18 to 30 hr postmethadone). In the first experiment physiologic and subjective responses were measured in seven ambulatory subjects at 2, 4, and 6 hr after a regular daily dose of methadone or placebo. In the second, physiologic measures were continuously monitored for 4 hr in six inactive seated subjects. In both studies, pupil diameter decreased after moderate to high methadone doses (35 to 80 mg). In the second experiment, heart rate fell and skin temperature rose significantly after methadone. Responses to the morphine-benzedrine group scale of the Addiction Research Center Inventory were elevated after methadone for most subjects in both studies, although there were individual differences in the magnitude and time course of this effect. Finally, low methadone maintenance doses of 10 and 20 mg/day had little or no effect on physiologic or subjective responses in two subjects. These studies showed that short-term effects of oral methadone can be readily detected during a 24-hr dosing regimen. The changes in function after the regular maintenance dose may result both from short-term opiate effects and relief of mild withdrawal.

Adult↗
PubMed1999

Additional methadone increases craving for heroin: a double-blind, placebo-controlled study of chronic opiate users receiving methadone substitution treatment.

AIMS: To assess the acute-on-chronic effects of methadone on drug craving, mood and cognitive and psychomotor functioning in patients on long-term methadone substitution treatment. DESIGN AND PARTICIPANTS: A double-blind, cross-over design was used to compare the effects of a 33% increase in patient's daily dosage of methadone with a matched placebo linctus. Eighteen patients completed the study; all were assessed pre- and post-drug on two separate testing days. FINDINGS: Methadone significantly increased both positive craving (expected positive effects) and negative craving (expected relief of withdrawal discomfort) for heroin. Patients were unable to distinguish between methadone and placebo treatments. No differences between treatments emerged in cognitive or psychomotor effects. In terms of mood, patients were more alert and more contented following placebo than following methadone. CONCLUSIONS: Additional methadone may "prime" cravings for heroin in methadone substitution patients.

Adult↗
PubMedDate not supplied

A pilot study to determine the usefulness of the urinary excretion of methadone and its primary metabolite (EDDP) as potential markers of compliance in methadone detoxification programs.

Fourteen subjects (selected on the basis of compliance with the methadone-maintenance program prescribed by the consultant psychiatrist in charge of their treatment) undergoing opiate detoxification by methadone-replacement therapy were studied to determine if a relationship exists between the dose of methadone prescribed and the urinary excretion of methadone and/or its primary metabolite, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP). After the derivation of this relationship, it was hoped that the urinary concentrations of methadone and/or EDDP could be used as a noninvasive technique to monitor the methadone compliance of 56 drug abusers. Despite statistically significant correlations (p<0.001) between methadone dose and urine concentrations of methadone and EDDP, the large variation in concentrations measured in the urine of drug abusers negated the possibility of any clear-cut relationship being confirmed. However, it may be possible to use excretion data to monitor individual compliance but only through long-term monitoring of individual subjects to establish their own intraindividual variation in excretion patterns.

Adult↗
PubMed2000

The analysis of methadone in nail clippings from patients in a methadone-maintenance program.

This study offers an analytical scheme for methadone in fingernail clippings. Nail specimens (0.18-16.33 mg) were collected from 30 consenting adults participating in a methadone-maintenance program along with questionnaires regarding their drug-use histories. The nail clippings were stored in plastic bags and transferred to the laboratory for analysis. They were decontaminated by sonication for 15-min intervals successively in 0.1% sodium dodecyl sulfate, water (three times), and methanol (three times). The methanolic washes were collected and screened for methadone by enzyme immunoassay (EIA). Three washes were found sufficient to provide EIA negative results. The decontaminated nail clippings were hydrolyzed in 1M NaOH. Aliquots of the hydrolysates were screened for methadone by EIA and confirmed by gas chromatography-mass spectrometry (GC-MS). The mean methadone concentrations in fingernail clippings determined by EIA and GC-MS were 32.8 and 26.9 ng/mg, respectively. Hydrolysates of the equivalent of 10 mg of blank nail clippings were spiked with known concentrations of methadone and analyzed by the developed procedures in order to determine extraction recoveries and limits of detection of the two techniques. Based on our results, fingernails appear to be a potentially useful biological specimen for the analysis of methadone and the monitoring of patient compliance to methadone-maintenance programs.

Adult↗
PubMed2002

Beliefs about methadone in an inner-city methadone clinic.

Despite being considered both the most effective treatment for heroin addiction and an essential tool in the prevention of human immunodeficiency virus (HIV), methadone maintenance (MM) is often held in low esteem by heroin addicts-even those in MM treatment. This survey examined current beliefs and attitudes about MM of patients at an inner-city clinic, and the personal experience and attitudes of these patients with this treatment. Consenting patients in a methadone clinic serving a poor population with high rates of human immunodeficiency virus infection were queried about their attitudes toward and beliefs about methadone using a 16-item questionnaire. Over 2 days, 315 questionnaires were completed (acceptance rate 40%), totaling 32% of the 1,000 clinic patients. Nearly 80% believed that methadone had a positive effect on his or her life, but 80% were certain or unsure as to whether methadone is bad for one's health, and a similar percentage (80%) believed that discontinuing methadone was an important goal. Patients continue to have strongly negative attitudes toward and beliefs about methadone despite their acknowledgement that methadone has been very positive for them as individuals. As a result, many patients leave MM treatment prematurely, and there are usually unfilled slots in MM programs in New York City, even while continued need exists (e.g., less than 25% of the heroin addicts in the city are in treatment). The restrictive nature of many MM programs may account for these attitudes and beliefs.

Adult↗
PubMed2004

Cost and cost-effectiveness of standard methadone maintenance treatment compared to enriched 180-day methadone detoxification.

AIMS: To compare the cost and cost-effectiveness of methadone maintenance treatment and 180-day methadone detoxification enriched with psychosocial services. DESIGN: Randomized controlled study conducted from May 1995 to April 1999. SETTING: Research clinic in an established drug treatment program. PARTICIPANTS: One hundred and seventy-nine adults with diagnosed opioid dependence. Intervention Patients were randomized to methadone maintenance (n = 91), which required monthly 1 hour/week of psychosocial therapy during the first 6 months or 180-day detoxification (n = 88), which required 3 hours/week of psychosocial therapy and 14 education sessions during the first 6 months. MEASUREMENTS: Total health-care costs and self-reported injection drug use. A two-state Markov model was used to estimate quality-adjusted years of survival. Findings Methadone maintenance produced significantly greater reductions in illicit opioid use than 180-day detoxification during the last 6 months of treatment. Total health-care costs were greater for maintenance than detoxification treatment ($7564 versus $6687; P < 0.001). Although study costs were significantly higher for methadone maintenance than detoxification patients ($4739 versus $2855, P < 0.001), detoxification patients incurred significantly higher costs for substance abuse and mental health care received outside the study. Methadone maintenance may provide a modest survival advantage compared with detoxification. The cost per life-year gained is $16 967. Sensitivity analysis revealed a cost-effectiveness ratio of less than $20 000 per quality-adjusted life-year over a wide range of modeling assumptions. CONCLUSIONS: Compared with enriched detoxification services, methadone maintenance is more effective than enriched detoxification services with a cost-effectiveness ratio within the range of many accepted medical interventions and may provide a survival advantage. Results provide additional support for the use of sustained methadone therapy as opposed to detoxification for treating opioid addiction.

Adult↗
PubMed2000

Application and validation of a urinary methadone metabolite (EDDP) immunoassay to monitor methadone compliance.

A total of 1381 urine specimens were screened using a Microgenics CEDIA urinary primary methadone metabolite (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine; EDDP) immunoassay (cut-off calibrator concentration of 100 microg/L) in combination with a Dade Behring EMIT urinary methadone immunoassay (cut-off calibrator concentration of 300 microg/L). Of these, 642 (46%) were found to be positive using the EDDP assay but only 541 (39%) were found to be positive by the methadone assay. Out of the 108 specimens which were EDDP-positive but negative by the methadone assay, 47 (7%) could not be confirmed as positive using the routine in-house method of gas chromatography incorporating nitrogen-specific detection. Of these 47 results, 38 were re-screened using a more sensitive gas chromatography-mass spectrometry (GC-MS) technique, which demonstrated the presence of EDDP in every case. There was insufficient specimen to analyse the remaining nine samples. There were seven specimens which gave negative results by the EDDP and GC-MS assays but which had methadone concentrations ranging from 4000 to 37,500 microg/L. These were therefore presumed to be 'spiked' with methadone, i.e. to have had methadone added to the specimen to yield positive screening results and simulate compliance. It is concluded that the Microgenics CEDIA EDDP assay is a sensitive and reliable technique to determine the compliance of subjects prescribed methadone for opiate detoxification and maintenance.

Calibration↗
PubMed2006

Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT): evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK.

Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT) has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics. The Randomised Injectable Opioid Treatment Trial (RIOTT) is a multisite, prospective open-label randomised controlled trial (RCT) examining the role of treatment with injected opioids (methadone and heroin) for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services), or whether such patients should be treated with injected methadone or heroin. Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis) are randomised to one of three conditions: (1) optimized oral methadone treatment (Control group); (2) injected methadone treatment; or (3) injected heroin treatment (with access to oral methadone doses). Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens negative for markers of illicit heroin in months 4 to 6). Secondary outcomes include measures of other drug use, injecting practices, health and psychosocial functioning, criminal activity, patient satisfaction and incremental cost effectiveness. The study aims to recruit 150 subjects, with 50 patients per group, and is to be conducted in supervised injecting clinics across England.

Journal Article↗
PubMed1976

Effect of cholingeric drugs on methadone-induced catalepsy and stereotypies in rats treated chronically with methadone.

The effects of antimuscarinic (atropine, scopolamine, methylscopolamine), muscarinic (RS86, pilocarpine), antinicotinic (mecamylamine, hexamethonium) and nicotinic (nicotine) cholinergic drugs on the catalepsy and stereotypies induced by acute methadone in rats treated chronically with methadone were studied. The antimuscarinic drugs potentiated and the muscarinic drugs antagonized the cataleptic effect of methadone, whereas the antimuscarinic drugs tended to antagonize and the muscarinic drugs potentiated the methadone-induced stereotypies. Nicotine initially slightly potentiated, and mecamylamine antagonized the cataleptic effect of methadone. The actions of the cholinergic drugs on the extrapyramidal motor effects of methadone were most probably central, because methylscopolamine and hexamethonium had only very weak actions. These results show that the effects of antimuscarinic and muscarinic drugs on the catalepsy and stereotypies induced by methadone are opposite to their effects on the catalepsy and stereotypies produced by drugs which are thought to act on the postsynaptic dopaminergic receptors.

Animals↗
PubMed1986

Choice of blind methadone dose increases by methadone maintenance patients.

In the present study, a choice procedure was used in an outpatient methadone maintenance clinic to examine preferences for different double-blind methadone dose increases in 5 male patients. Subjects chose between 50 mg vs. 50 mg, 60 mg, 75 mg and 100 mg of methadone. In the 50 mg vs. 50 mg condition, each alternative was selected equally often. Percent selection of the higher doses (60, 75 and 100 mg) over the 50 mg dose of methadone increased in a dose-related fashion. Subject self-reports were consistent with methadone's opiate-like properties with dose-related trends being noted in most scales (e.g. opiate effects, drug liking). Overall, the results show that a choice procedure can be used successfully to assess the reinforcing properties of drugs in methadone maintenance patients and that methadone dose increases can function as a reinforcer in this population even under blind dosing conditions.

Adult↗
PubMed2005

Peginterferon alfa-2a does not alter the pharmacokinetics of methadone in patients with chronic hepatitis C undergoing methadone maintenance therapy.

OBJECTIVE: Our objective was to quantify the pharmacokinetics of methadone and the pharmacokinetics and pharmacodynamics of peginterferon alfa-2a (40 kd) in patients with chronic hepatitis C undergoing methadone maintenance therapy. METHODS: Adults with chronic hepatitis C who had been receiving a consistent methadone maintenance regimen for at least 3 months were eligible for this open-label, multicenter, nonrandomized drug interaction study. All patients received 180 microg subcutaneous peginterferon alfa-2a once weekly for 4 weeks and continued their methadone regimen. Serial blood samples were collected at baseline and immediately before and for up to 168 hours after study drug administration for the purposes of quantifying methadone and peginterferon alfa-2a serum concentrations, measuring serum 2',5'-oligoadenylate synthetase activity, and determining hepatitis C virus ribonucleic acid levels. RESULTS: Twenty-four patients were enrolled. Methadone exposure, as measured by maximum serum concentration (C(max)) and area under the concentration-time curve (AUC) normalized to a 100-mg/d dose, after 4 doses of peginterferon alfa-2a increased by 10% to 15% when compared with baseline. The week 4/baseline ratio of the mean C(max) was 1.11 (90% confidence interval [CI], 1.02-1.22), and for AUC from time 0 to 24 hours, the week 4/baseline ratio was 1.15 (90% CI, 1.08-1.23). The mean accumulation ratios (week 4/first dose) for C(max) and AUC from time 0 to 168 hours of peginterferon alfa-2a were 2.1 and 2.3, respectively. CONCLUSIONS: Peginterferon alfa-2a does not appreciably alter the pharmacokinetics of methadone.

Area Under Curve↗
PubMed2005

Significantly higher methadone dose for methadone maintenance treatment (MMT) patients with chronic pain.

The aim of this study is to characterize patients with chronic pain in methadone maintenance treatment (MMT). Between September and December, 2003, 170 consecutive patients from an MMT clinic participated in a questionnaire survey on pain (duration and severity). Chronic pain was defined as current pain lasting for >or=6 months. The patients' maintenance methadone dosage and urine tests for drug abuse during the month before and of the survey were recorded. Of the 170 patients, 94 (55.3%) experienced chronic pain. They had a significantly higher proportion of chronic illness (74.5%) compared to non-pain patients (44.7%) (Fisher's Exact Test P<0.0005). Twelve (12.8%) of the chronic pain patients scored their pain as mild, 38 (40.4%) as moderate, 22 (23.4%) as severe and 22 (23.4%) as very severe. Pain duration significantly correlated with pain severity (Pearson R=0.3, P>0.0005) and was significantly associated with methadone daily dosage: patients with pain duration of >or=10 years (n=26) were receiving the highest methadone dosage (182.1+/-59.2 mg/day), those with pain duration from 1 to 10 years (n=59) 160.9+/-56.2 mg/day, and those with pain duration of <1 year (n=9) 134.2+/-73.2 mg/day. Patients in the non-pain group (n=76) were receiving 147.1+/-52.8 mg/day of methadone (ANOVA, F=3.1, P=0.03). We conclude that pain duration and severity significantly correlated. Although methadone was not prescribed for the treatment of pain but rather for opiate addiction, the patients in the MMT clinic with prolonged pain were prescribed a significantly higher methadone dosage compared to patients with short pain duration, and non-pain patients.

Adult↗