A controlled trial comparing buprenorphine and methadone maintenance in opioid dependence.

BACKGROUND: Buprenorphine is a partial agonist at the mu-opioid receptor that has been proposed as an alternative to traditional full agonist maintenance therapy for the treatment of opioid addiction. We report on a clinical trial in which the relative safety and efficacy of long-term fixed-dose buprenorphine maintenance was examined in comparison to low- and high-dose methadone maintenance. METHODS: Two hundred twenty-five treatment-seeking opioid addicts (46 women, 179 men) were randomly assigned to receive, in a double-blind manner, either 8 mg/d of buprenorphine, 30 mg/d of methadone, or 80 mg/d of methadone maintenance over a 1-year period. Objective and subjective measures of efficacy (urine toxicology, retention, craving, and withdrawal symptoms) were examined at the study midpoint and at termination, and safety data were tabulated over the entire 52-week study period. RESULTS: Patients assigned to high-dose methadone maintenance performed significantly better on measures of retention, opioid use, and opioid craving than either the low-dose methadone or the buprenorphine group at both 26-week and 52-week time points. Performance on these measures was virtually identical between the latter two groups. No serious adverse health effects attributable to buprenorphine were noted. CONCLUSIONS: Buprenorphine maintenance at 8 mg/d appears to be less than optimally efficacious under the conditions of the present study. Continued research is needed to reconcile these findings with the more positive results reported by other investigative groups. There are no apparent health risks associated with long-term buprenorphine maintenance at this dosage.

La Pharmacodépendance : méthodes pour l' évaluation du traitement et de la réhabilitation / A. Arif ... [et al.]

Décrit une méthodologie simple, pratique et aisément adaptable pour l'évaluation des progrès réalisés dans le traitement et la réadaptation des sujets pharmacodépendants. Cette méthodologie, qui est l'aboutissement d'un projet de recherche et d'évaluation sur l'épidémiologie de la pharmacodépendance doit servir à mesurer les résultats du traitement pour différents types d'utilisateurs de drogues recevant différents types de traitement dans différents environnements socio-culturels. La majeure partie de l'ouvrage est constituée par le commentaire détaillé de quatre séries de formulaires d'enregistrement. Les formulaires sont reproduits intégralement, avec des instructions pour leur utilisation, des informations sur le traitement des données et une analyse des problèmes rencontrés dans la conception et l'exécution d'études réalisées à l'aide de ces instruments

Drug dependence : a methodology for evaluating treatment and rehabilitation / A. Arif ... [et al.]

Describes a simple, practical, and adaptable methodology for monitoring progress in the treatment and rehabilitation of drug-dependent persons. The methodology, which stems from a research and reporting project on the epidemiology of drug dependence, is designed for use in measuring treatment outcome for different types of drug users receiving different types of treatment in different sociocultural environments. The main part of the book consists of detailed information on four sets of data recording forms. The forms are reproduced in full detail, together with instructions for their use, information on data processing, and an analytical description of issues encountered in the design and implementation of studies using these instruments

Patient perspectives of opiate withdrawal.

The objective of this study was to gather information on some aspects of the opiate withdrawal experience from the perspective of the addict. For the most part, results were consistent with expectation, e.g., the sequence with which symptoms appear during withdrawal. However, there were some unexpected findings: the patients' report of the severity of the various symptoms differed from that of experienced clinicians, patients emphasizing more the psychological symptoms. Withdrawal symptoms experienced while on methadone maintenance are also documented.

Relapse of psychiatric patients in foster care.

The authors examined factors related to relapse of psychiatric patients within 1 year of placement in a foster home. They collected data on 210 male patients who had been hospitalized in VA medical centers who were discharged to foster homes in five states. Slightly fewer schizophrenic than nonschizophrenic patients relapsed, but age, length of hospitalization, number of previous hospitalizations, marital status, education, and income did not predict relapse. There was a suggestion that relapsed schizophrenic patients may be characterized before hospital discharge by hyperactivity, undermedication or drug noncompliance, and fewer social skills.

Foster home characteristics and psychiatric patient outcome. The wisdom of Gheel confirmed.

Even with the emphasis on deinstitutionalization, mental health services are still skewed toward hospital and nursing home care. A relatively untapped resource that is likely to receive more attention is the foster home. We previously demonstrated, in a controlled study of psychiatric patients randomly assigned to foster care or continued hospitalization, that foster care produced better social adjustment within four months. From that study we examine characteristics of foster homes associated with the improvement in social functioning. Improved outcome was related to more children in the homes, fewer boarders, and smaller size. Too much stimulation in the environment, more supervision by foster care sponsors, and more intensive follow-up by social work staff was bad for schizophrenic patients but good for nonschizophrenic patients. Neither the sponsors' tolerance and expectation nor the cost of foster care was related to outcome. The size and composition of homes are important and attention needs to be given to finding an enriched environment that is neither too stimulating nor too sterile for schizophrenic patients.

Restabilization with methadone after methadyl acetate maintenance.

Sixty-eight heroin addicts maintained for 40 weeks on a regimen of methadyl acetate or methadone hydrochloride in a double-blind study were transferred to a uniform dose of 60 mg of methadone daily at the end of their tenure in the study. They were observed for the ensuing six weeks, during which their daily methadone doses were adjusted according to their clinical needs. Patients were observed for symptoms and signs of discomfort and for the amount of illicit drug use during this period of transition. The results indicate that patients maintained on a regimen of methadyl acetate can be readily restabilized with methadone and that sudden decrease of the methadone dose tends to result in the patient's supplementing with illicit heroin. Conversely, increasing methadone doses resulted in a corresponding reduction in illicit drug use. It is suggested that a chronic covert abstinence syndrome may exist in some patients receiving long-term methadone maintenance therapy, and that while it may contribute to their continued illicit drug use, it may have a different pathophysiologic basis and require different therapeutic considerations.

Day treatment and psychotropic drugs in the aftercare of schizophrenic patients. A Veterans Administration cooperative study.

Schizophrenic patients referred for day treatment at the time of discharge from ten hospitals were randomly assigned to receive day treatment plus drugs or to receive drugs alone. They were tested before assignment and at 6, 12, 18, and 24 months on social functioning, symptoms, and attitudes. Community tenure and costs were also measured. The ten day centers were described on process variables every six months for the four years of the study. Some centers were found to be effective in treating chronic schizophrenic patients and others were not. All centers improved the patients' social functioning. Six of the centers were found to significantly delay relapse, reduce sumptoms, and change some attitudes. Costs for patients in these centers were not significantly different from the group receiving only drugs. More professional staff hours, group therapy, and a high patient turnover treatment philosophy were associated with poor-result centers. More occupational therapy and a sustained nonthreatening environment were more characteristic of successful outcome centers.

A cooperative clinical study of methadyl acetate. I. Three-times-a-week regimen.

This was an open clinical trial of methadyl acetate (LAAM) compared with methadone in the maintenance of 636 heroin addicts who had previously been stabilized on a maintenance regimen of methadone. The starting sample assembled by the 13 cooperating clinics were randomly assigned to continued maintenance on methadone (= 308) or crossed over to methadyl acetate (= 328) for a period of 40 weeks. The starting dose was identical to the previously established dose of methadone, but beginning with the second visit, dosage was flexible. Safety was evaluated by clinical and laboratory observations conducted at four-week intervals throughout the study. Relative efficacy was evaluated by illicit drug use, program retention and attendance, and global staff judgments. It is concluded that methadyl acetate is as safe as methadone and, when given three times a week, is an acceptable and effective maintenance drug for many heroin addicts.

Hospital vs community (foster) care for psychiatric patients.

The aim of this study was to determine the effectiveness of foster care preparation and placement. Five hundred seventy-two patients from five hospitals were randomly assigned to foster care preparation (experimentals) or continued hospitalization (controls). They were studied before assignment, at placement of experimental subjects, and four months later regarding social functioning, mood, activity, and overall adjustment. Hospitals averaged two months preparing experimental subjects, resulting in 73% placed in foster care. Little change was observed between referral and placement. However, four months after placement, experimental subjects were significantly improved over controls, particularly in social functioning and adjustment. After four months, 88% of the foster care subjects were in the community. Findings suggest that attention should be given to selection criteria, that lengthy preparation may be unnecessary, and that foster care is superior to hospitalization for patients who cannot return to their own homes.

Methadyl acetate and methadone as maintenance treatments for heroin addicts. A veterans administration cooperative study.

This was a double-blind comparison of methadyl acetate and two dose levels of methadone hydrochloride in the maintenance of 430 street heroin addicts from 12 Veterans Administration hospitals. The starting sample consisted of 146 patients receiving low-dose methadone, 142 patients receiving methadyl acetate. Patients were first given 30 mg of both drugs, and doses were incremented by 10 mg/week until they stabilized at methadyl acetate, 80 mg three times a week, and methadone hydrochloride, 50 mg daily or 100 mg daily. Dosage was fixed for the balance of the 40-week treatment period. Safety was evaluated by clinical and laboratory observations conducted at frequent intervals throughout the study. Relative efficacy was evaluated by illicit drug use, program retention and attendance, and global staff judgments. It is concluded that methadyl acetate is as safe a drug as methadone and that it compares favorably with highdose methoadone in terms of efficacy. Both methyadyl acetate and high-dose methadone appear to be better maintenance regimens than low-dose methadone under the conditions of this study.