[Ibogaine] Fw: Anniversary of methadone treatment for addiction. Untold savings in lives, suffering and spending.

HSLotsof at aol.com HSLotsof at aol.com
Fri Aug 12 13:05:18 EDT 2005


Hi Preston,

On this date in the US there are 215,000 people taken our of harms way of the 
police for opoid use by their participation on methadone maintenance.  That 
certainly is cause for celebration.  I saw your posting of Andrew Byrne's email 
and called up Dr. Dole who has been quite supportive of and interested in 
ibogaine to wish him a happy 40th.

Howard

In a message dated 8/12/05 2:05:15 AM, ptpeet at nyc.rr.com writes:

<< Oh boy, what a day for celebration, eh?



Peace and love,

Preston Peet


"Madness is not enlightenment, but the search for enlightenment is often 
mistaken for madness"

Richard Davenport-Hines


ptpeet at nyc.rr.com

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Editor "Under the Influence- the Disinformation Guide to Drugs"

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----- Original Message ----- 

From: Andrew Byrne 

To: ajbyrne at ozemail.com.au 

Sent: Thursday, August 11, 2005 9:20 PM

Subject: Anniversary of methadone treatment for addiction. Untold savings in 
lives, suffering and spending.



Dear Readers, 


 


It is 40 years on 23rd August since the first report of methadone treatment 
for addiction.  Dole and Nyswander's seminal paper (below) is one of the most 
cited in the medical literature.  It stands as a model for all medical 
researchers, being a funded trial in a clinical research ward.  Although essentially a 
simple report of 24 Manhattan heroin addicts treated with a new intensive 
protocol utilising supervised oral daily methadone, it effectively defined the 
field for decades with its foresight and thoroughness.  Having only two early 
drop-outs, the 22 successful patients are described in detail, including 
hospital ward induction, average daily doses over 100mg, daily urine testing and, in 
addition to routine physical examinations, radio-iodine thyroid tests and bone 
marrow findings.  These pioneers also tested for physical coordination to 
determine safety at home and in the work place.  Patients were even given 
laxatives for the ubiquitous constipation.  


 


By 1970 Australian addicts were being offered similar treatment due to the 
frontier work of Dr Stella Dalton.  The treatment is now available in virtually 
every western country and is being introduced into some parts of the third 
world.  


 


The JAMA paper speaks for itself.  It remains a lasting tribute to its 
authors and acknowledged contributors: 


 


Published in Journal of the American Medical Association (JAMA) on 23 August 
1965


 


A Medical Treatment for Diacetylmorphine (Heroin) Addiction


 


A Clinical Trial With Methadone Hydrochloride


 


Vincent P. Dole, MD, and Marie Nyswander, MD


 


A group of 22 patients, previously addicted to diacetylmorphine (heroin), 
have been stabilized with oral methadone hydrochloride. This medication appears 
to have two useful effects: (1) relief of narcotic hunger, and (2) induction of 
sufficient tolerance to block the euphoric effect of an average illegal dose 
of diacetylmorphine. With this medication, and a comprehensive program of 
rehabilitation, patients have shown marked improvement; they have returned to 
school, obtained jobs, and have become reconciled with their families. Medical and 
psychometric tests have disclosed no signs of toxicity, apart from 
constipation. This treatment requires careful medical supervision and many social 
services. In our opinion, both the medication and the supporting program are 
essential.


 


 


The question of "maintenance treatment" of addicts is one that is often 
argued but seldom clearly defined. If this procedure is conceived as no more than 
an unsupervised distribution of narcotic drugs to addicts for 
self-administration of doses and at times of their choosing, then few physicians could accept 
it as proper medical practice. An uncontrolled supply of drugs would trap 
confirmed addicts in a closed world of drug taking, and tend to spread addiction. 
This procedure certainly would not qualify as "maintenance" in a medical sense. 
Uncontrolled distribution is mentioned here only to reject it, and to 
emphasize the distinction between distribution and medical prescription. The question 
at issue in the present study was whether a narcotic medicine, prescribed by 
physicians as part of a treatment program, could help in the return of addict 
patients to normal society.


 


No definitive study of medical maintenance has yet been reported. The Council 
on Mental Health of the American Medical Association, after a thorough review 
of evidence available in 1957,1 concluded that "The advisability of 
establishing clinics or some equivalent system to dispense opiates to addicts cannot be 
settled on the basis of objective facts. Any position taken is necessarily 
based in part on opinion, and on this question opinions are divided." With 
respect to previous trials of maintenance treatment, the Council found that 
"Assessment of the operations of the narcotic dispensor between 1919 and 1923 is 
difficult because of the paucity of published material. Much of the small amount 
of data that is available is not sufficiently objective to be of great value in 
formulating any clear-cut opinion of the purpose of the clinics, the way in 
which they operated, or the results attained." No new studies bearing on the 
question of maintenance treatment have appeared in the eight years since this 
report was published. Meanwhile, various medical and legal committees have 
called for additional research.2,6


 


See also page 673 ['Dependence on Barbiturates and Other Sedative Drugs']


 


The present study, conducted under the auspices of the departments of health 
and hospitals, New York city, has yielded encouraging results; patients who 
before treatment appeared hopelessly addicted are now engaged in useful 
occupations and are not using diacetylmorphine (heroin). As measured by social 
performance, these patients have ceased to be addicts. It must be emphasized that thi
s paper is only a progress report, based on treatment of 22 patients for 
periods of 1 to 15 months. Such limited study obviously does not establish a new 
treatment for general application. The results, however, appear sufficiently 
promising to justify further trial of the procedure on a larger scale.


 


Procedure


The patients admitted to the program to date were men, aged 19 to 37, 
"mainline" diacetylmorphine users for several years with history of failure of 
withdrawal treatment. They have reported no substantial addictions to other agents 
(although most of them had used barbiturates or tranquilizers when narcotic 
drugs were unavailable), and they were not psychotic. Patients came from the 
streets, from drug withdrawal units, from referrals by social agencies and 
physicians who had heard of the program, and from recruitment of addicted friends by 
patients under treatment. Further details of their history are given in the 
Table.


 


Division of Program Into Three Phases.-PHASE 1.-The addict patients were 
stabilized with methadone hydrochloride in an unlocked hospital ward, given a 
complete medical workup, psychiatric evaluation, a review of family and housing 
problems, and job-placement study. After the first week of they were free to 
leave the ward for school, libraries, shopping, and various amusements-usually, 
but not always, with one of the staff. Patients lacking a high school diploma 
started in classes that prepare students for a high school equivalency 
certificate. For the present study the time in this initial phase was arbitrarily set 
at six weeks.


 


During this phase of hospitalization, the treatment unit was kept small (four 
to nine patients). This was felt necessary because most patients started the 
treatment with serious anxieties and doubts. The limitation of patient load 
allowed the staff to individualize the daily ward activities and deal with the 
special problems of each patient.


 


PHASE 2.-This began when subjects left the hospital and became outpatients, 
returning every day for methadone medication. They were asked to drink their 
medication in the presence of a clinic nurse, and to leave a daily urine 
specimen for analysis. When indicated, this rule has been relaxed; reliable patients 
who have been on the program for several months have been given enough 
medication for a weekend at home or a short trip. Continued contact with the hospital 
staff was provided as required. The most important services needed during 
this phase of treatment were help in obtaining jobs, housing, and education.


 


PHASE 3.-This phase is the goal of treatment, the stage in which an ex-addict 
has become a socially normal, self-supporting person. The two patients who 
are considered to have arrived at this phase are still receiving maintenance 
medication since the physicians in charge of their treatment feel that withdrawal 
at this time would be premature. Supervision of their medication is as 
careful as in phase 2; the only distinction between patients in phases 2 and 3 is in 
the degree of social advancement.


 


PHASE 1A.-This phase designates a special group of four patients who are 
being maintained on high doses under close and continuing observation to reveal 
any delayed toxic effects of methadone (Table). So far, none have been found. 
These patients live on a metabolic ward, and so are still classified in phase 1, 
but as measured by social adjustment they have progressed to phase 2 or 3, 
since all are either employed or going to school. The ward serves mainly as 
their residence, which they are free to leave as they wish subject only to the 
general routine of hospital activities.


 


Narcotic Medication.-Patients have differed markedly in tolerance to 
narcotics at the beginning of treatment, and in the rate with which they have adapted 
to increasing doses of medication. Individualization of treatment thus has 
been necessary. A rough estimate of initial tolerance was made from each new 
patient's history of drug usage, with allowance for exaggeration since addicts 
coming to a maintenance program usually fear that physicians will not prescribe 
enough medication, and with recognition of the fact that the number of "bags" 
used by an addict is not a reliable measure of narcotic tolerance. The 
diacetylmorphine content of a "bag" obtained on the street today is low and variable. 
This estimate provided a guide to initial dosage, but the only sure way to 
measure tolerance is to observe the reaction to test doses of narcotic drugs. The 
schedule, therefore, differed for each patient.


 


On admission patients usually have shown mild or moderately severe symptoms 
of abstinence, the last shot of diacetylmorphine having been taken some hours 
before. These patients were relieved promptly by one or two doses of morphine 
sulfate (10 mg) or dihydromorphone (Dilaudid) hydrochloride (4 mg), given 
intramuscularly, and then started on oral methadone hydrochloride therapy (10 to 20 
mg, twice daily). Patients coming to treatment without symptoms were started 
on a regimen of methadone without other medication, but were watched carefully 
for appearance of symptoms after admission. After the first 24 hours most 
patients could be maintained comfortably on the oral medication alone. The dose 
of methadone hydrochloride was increased gradually over the next four weeks to 
stabilization level (50 to 150 mg/ day). Two patients in whom tolerance at the 
expected rate failed to develop have been held at lower doses (Table). With 
some patients, treated early in the study, the buildup of dosage was too rapid; 
they became overly sedated for a few days, and two of them had transient 
episodes of urinary retention and abdominal distention. Other patients, given too 
little, have become abstinent, exhibiting malaise, nausea, sweating, 
lacrimation, and restlessness. With more accurate prescription, patients have not 
become euphoric, sedated, or sick from abstinence at any stage of treatment. They 
have simply felt normal, and have not asked for more medication.


 


After the patients reached maintenance level, the morning and evening doses 
were combined by progressive reduction of the evening medication with an equal 
addition to the methadone taken in the morning. After discharge from the 
hospital patients could thus be maintained by a single daily visit to the 
outpatient clinic. The patients who have had difficulty in spanning a 24-hour period 
with a single dose have been given medication to take at home; this has been a 
minor problem, limited to those who could visit the clinic only in the evening. 
In all cases it has been made clear to the patients (and accepted by them as 
a condition of treatment) that the amount of medication and the dosage 
schedule were the responsibility of the medical staff. Physicians did not discuss 
dosage with the patients, although of course they listened carefully to any 
report of symptoms that might suggest excess or lack of medication.


 


Laboratory Control.-The urine of every patient was collected daily in the 
hospital and at each clinic visit, to be analyzed for methadone, morphine (the 
chief metabolite of diacetylmorphine), and quinine (a regular constituent of the 
street "bag"). The thin layer chromatographic method of Cochin and Daly7 was 
used, after preliminary extraction of the alkaloids from urine with cation 
exchange resin. The sensitivity of the procedure was such that it would give a 
definite positive if a patient had taken an average "bag" of diacetylmorphine 
during the preceding 24 hours.


 


Results


The most dramatic effect of this treatment has been the disappearance of 
narcotic hunger. All of the patients previously had made efforts to remain 
drug-free after withdrawal, but were unable to resist the craving. Drug hunger became 
intolerable for most of them shortly after discharge from withdrawal unit and 
return to their neighborhood. It became especially severe when they were 
exposed to emotional stress. With methadone maintenance, however, patients found 
that they could meet addict friends, and even watch them inject 
diacetylmorphine, without great difficulty. They have tolerated frustrating episodes without 
feeling a need for diacetylmorphine. They have stopped dreaming about drugs, 
and seldom talk about drugs when together. Patients have even become so 
indifferent to narcotics as to forget to take a scheduled dose of medication when 
busy at home.


 


The extent to which the patients have ceased to behave as addicts, and their 
reliability in reporting illegal drug use, were verified by the results of 
urinanalysis. Negative results in almost all analyses showed that use of 
diacetylmorphine has been rare and sporadic, although the patients have had ample 
exposure to addict friends and pushers. Remarkably, the episodes of drug taking 
were reported by the patients spontaneously, and their reports have correlated 
with the laboratory evidence.


 


An interesting phenomenon, which has been seen in several patients, was the 
production of symptoms typical of drug deficiency by acute emotional stress. 
Anxiety in some susceptible patients caused malaise, nausea, yawning, and 
sweating, indistinguishable from the effects of abstinence, even though the patients 
were being maintained on large doses of medication. After experiencing relief 
with reassurance but without additional medication, susceptible patients have 
become less alarmed by these symptoms, and the episodes have occurred less 
frequently. In two other patients symptoms suggesting abstinence have appeared 
in the course of mild respiratory-tract infections. These symptoms, not 
associated with anxiety, were difficult to evaluate, but in any event disappeared in 
a few days without need for increase in medication. These observations suggest 
that the effectiveness of methadone can vary with changes in psychological 
and metabolic state.


 


The degree of tolerance established by methadone was titrated in six patients 
by giving diacetylmorphine, morphine, dilaudid, or methadone intravenously in 
a double-blind study. The drugs were given in randomized order and various 
doses six hours after the last administration of methadone. Stabilization with 
methadone, as here described, was found to make patients refractory to 40 to 80 
mg diacetylmorphine (which would cost $10 to $25 if purchased on the street). 
Larger amounts were not systematically tested; probably blocking would extend 
to greater doses since two patients with high tolerance showed little 
reaction to intravenous injection of 200 mg of diacetylmorphine-a huge amount, 
possibly enough to kill a nontolerant individual.


 


Unscheduled, but perhaps necessary, experiments in drug usage were made by 
four patients. These subjects found that they did not "get high" when "shooting" 
diacetylmorphine with addict friends on the street. Both the patients and 
their friends were astounded at their lack of reaction to the drug. They 
discontinued these unrewarding experiments without need for disciplinary measures, and 
have discouraged other patients from repeating the experiment. So long as 
patients take methadone as scheduled, they apparently cannot feel the euphoria of 
an addict taking a street bag of diacetylmorphine.


 


Complications.-The chief medical problem has been constipation. The tonus of 
the sigmoid and the defecation reflex remain depressed even in patients with 
high tolerance to the narcotic effects of methadone, while the motility of the 
upper gastrointestinal tract appears to be unaffected. Five patients, given a 
barium sulfate meal and followed with daily x-ray examinations for a week, 
showed normal or only slightly delayed passage of barium through the small 
intestine, but in three of the five, the evacuation of barium from the colon was 
abnormally slow. Fecal impaction has occurred when patients have made no effort 
to defecate for several days. Patients therefore were instructed to take a 
hydrophilic colloid every day, and a supplementary laxative or enema if bowels 
have not moved for three days. With these precautions patients have had no 
further difficulty.


 


Apart from constipation, patients have shown no major ill effects ascribable 
to use of methadone. The tendency of addicts to leukocytosis (9,000 to 14,000 
white blood cells/cu mm with 60% to 80% polymorphonuclear cells10 continued, 
apparently unaffected by this medication. Bone marrow biopsies in four patients 
after eight months of treatment were normal. No effect of methadone on renal 
function was disclosed by repeated urinanalyses. Liver-function tests, when 
originally normal, remained so. Results of basal metabolic rate, thyroid uptake 
of sodium iodide I 131, red blood cell uptake of labelled triiodothyronine, 
and plasma protein-bound iodine were normal in three patients who had been 
stabilized on methadone hydrochloride (100 to 150 mg/day) for four to six months. 
Some patients have reported excess sweating in hot weather, but no one has been 
unable to work for this reason. Mental and neuromuscular functions appear 
unaffected. Patients have performed well in school and at various jobs. Studies 
of motor skill (accuracy in tracking moving targets) showed normal 
coordination. We have not yet been able to find a medical or psychological test capable of 
distinguishing patients on methadone therapy from normal controls. They can, 
of course, be distinguished by urinanalysis.


There has been no problem so far in holding patients. Only two of the 
patients who started treatment have been discharged. These uncooperative and 
disruptive psychopaths were transfered to withdrawal units. Two others who were 
admitted specifically for tolerance tests at an early stage of the study were 
returned (as originally planned) to the withdrawal unit from which they came; both 
subsequently have asked to return to the program. A fifth patient signed out 
after only four days on the ward, and also asked to return.


 


Comment


Previous efforts to treat addict patients with narcotic medication have been 
handicapped by lack of sufficiently long-acting agents. The Council's report 
noted that in 1919 to 1923 experience, "in all instances it was eventually 
found necessary to give drugs to addicts for self-administration." This is 
inherent in the pharmacology of parenterally administered morphine, which was used in 
these clinics and would probably apply to other agents with short periods of 
action such as diacetylmorphine, dihydromorphine, or meperidine. If addict 
patients are to be maintained with any of these drugs, they would need several 
injections per day; otherwise they would return to the street for additional 
drugs.


 


Projected into large-scale treatment, a medical use of short-acting narcotic 
drugs would require dispensaries staffed to give thousands of injections per 
day, with rooms or park benches in the neighborhood for addicts to wait between 
shots. Alternatively, physicians would have to yield control of drug 
administration to the addicts themselves. Neither alternative is acceptable. With 
methadone, however, the situation is much different since patients can be 
stabilized with a single daily dose, taken orally, under medical control. Maintenance 
of patients with methadone is no more difficult than maintaining diabetics 
with oral hypoglycemic agents, and in both cases the patient should be able to 
live a normal life. 


 


We believe that methadone has contributed in an essential way to the 
favorable results, although it is quite clear that giving of medicine has been only 
part of the program. This drug appears to relieve narcotic hunger, and thus free 
the patient for other interests, as well as protect him against readdiction 
to diacetylmorphine by establishing a pharmacological block. A previous attempt 
by one of us (M.N.) to treat addict patients without narcotic medication 
ended in failure. Other clinics, attempting to rehabilitate patients after 
withdrawal, have had equally poor results. These, however, are indirect arguments. 
When the treatment program is sufficiently well established, the necessary 
control studies with social support, but without medication, must be made.


 


This study was supported by the Health Research Council grant U-1501 of New 
York city, and by the National Association for Prevention of Addiction to Nar
cotics.


 


Major contributions to this investigation were made by the following: Mary 
Jeanne Kreek, MD, bone marrow biopsies and tests of narcotic tolerance; Joyce 
Lowinson. MD. and George Lowen, MD, expansion of the program at Manhattan 
General Hospital; Nathan Poker, MD, measurements of intestinal motility; David 
Becker, MD, and Eugene Furth, MD. tests for thyroid function; and Norman Gordon, 
MD, Alan Warner, and Ann Henderson, measurements of motor skills of patients and 
ratings with intelligence tests and mood scales. 


 


Generic and Trade Names of Drug 


Sodium iodide I 131-Iodotope-1 131, Oriodide-131, Radiocaps131, 
Theriodide-131, Tracervial-131.


 


References: 


1. Council on Mental Health: Report on Narcotic Addiction, JAM/i 
165:1707-1713 (Nov 30); 1834-1841 cDec 7 1968-1974 (Dec 14) 1957.


2. Joint Committee of American Bar Association and American Medical 
Association of Narcotic Drugs. Interim and Final Reports: Drug Addiction: Crime or 
Disease? Bloomington, MD: Indiana University Press, 1961.


3. Presidents Advisory Commission on Narcotic and Drug Abuse. Appendix 1. 
Final Report, US Government Printing Office. Nov 1963.


4. New York Academy of Medicine, Committee on Public Health: Report on Drug 
Addiction: II, Bull NY Aced Med 39:417-473 (July) 1963.


5. Eldridge, W.B.: Narcotics and Law, Chicago: American Bar Foundation, 1962.


6. National Council on Crime and Delinquency. Advisory Council of Judges. 
Narcotics Law Violations: Policy Statement, New York. 1964.


7. Cochin. J.. and Daly, ,J.: Rapid Identification of Analgesic Drugs in 
Urine With Thin-Layer Chromatography, Experientia 18:294-295 (June 15) 1962.


8. Light. AB., and Torrance. E.G.: Opium Addiction: VI. Effects of Abrupt 
Withdrawal Followed by Readministration of Morphine in Human Addicts With 
Spectral Reference to Composition of Blood, Circulation, and Metabolism, Arch Intern 
Med 44:1-16 (July) 1929.


9. Ishell, H.. et al: Liability of Addiction of 6-Dimethylamino-


4.4-diphenyl-3-heptanone (Methadon, "Amidone" or "10820") in Man. Arch Intern 
Med 82:362-392 (Oct) 1948.


10. Berle, B., and Nyswander, M.: Ambulatory Withdrawal Treatment of Heroin 
Addicts, New York J Med 64:1846-1848 (July) 1964.


 


Citation:


Dole VP, Nyswander ME. A medical treatment for diacetylmorphine (heroin) 
addiction. J Amer Med Assoc 1965;193:646-50  


 




Table 1. (legend) see attached xls file. 


 


Maintenance Therapy of Ex-Addicts With Methadone Hydrochloride, Summary of 
First


15 Months (February 1964 to May 1965). 


 


*For comparison with other treatment series, patients classified into three 
groups: Western European ancestry (E), Puerto Rican and Cuban (F), and Negro 
(N).


 


~ Age first used diacetylmorphine (FD); age at admission (A).


 


d Number of admissions to Federal Hospital-Lexington, Ky (F), state 
hospitals-Manhattan State, Central Islip (S), municipal hospital -Manhattan General, 
Metropolitan, Riverside (M), private clinics and groups, including Synanon (P).


 


§ All but two patients were employed at time of admission. Job indicated is 
best position ever held, 


 


Time in Army (A), Navy (N), Marines (M), or Air Force (AF).


 


¶ Dose methadone hydrochloride given orally, mg/day.


 


# Phases of treatment: la-four patients, residents on metabolic ward of 
Rockefeller Institute; 1-new patients being stabilized on methadone therapy, they 
sleep in hospital but may leave during day for school, shopping, or job; 
2-patients newly discharged, living at home or rooming house, needing social support
; 3-ambulatory patients who are self-supporting. 


 


** High school equivalency status: If not a high school graduate, each 
patient was encouraged to enroll in night school to prepare for high school 
equivalency certificate. Those who have completed this course, passed examination, and 
received certificate are indicated by 'Cert'; those now in night school 
indicated by NS."


 


 


Posted by Andrew Byrne, Sydney addiction doctor.  >>




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