Claus E. Petersen <snurrberget@yahoo.com.removethis> wrote:
> Claus E. Petersen wrote:
> > Jesper wrote:
> >> Så vil Sosserne have forsøg med statsnarkomaner på Heroin. Det er den
> >> unge og formentligt temmeligt uerfarne Mette Frederiksen der føre an i
> >> dét hylekor. Baggrunden er det brutale miljø hvor narkomaner
> >> prostituerer sig for at få penge til stoffer. Løsningen er bare ikke fri
> >> heroin, det er som at give en alkoholiker alkohol. Hvis sosserne
> >> virkeligt bekymrede sig for narkomanernes ve og vel ville de sikre at de
> >> blev afvænnet, om nødvendigt med tvang. Midlet findes i dag til at gøre
> >> heroinnarkomaner 100% stoffri og det hedder Vivitrol. Det er Naltrexone
> >> depotmedicin, en indsprøjtning holder en hel måned og i den periode
> >> bliver virkningen af heroin, morfin, Ketogan, Metadon, Contalgin alkohol
> >> og mange andre stoffer helt og aldeles blokeret, det er omgående kold
> >> tyrker og der er intet der lindre før abstinenserne er væk. Det er kun
> >> et spørgsmål om give narkomanerne den ene sprøjte Vivitrol én gang om
> >> måneden, hvor svært kan det være?
> >>
> >
> > Stoffet er tiltænkt afvænning af alkoholikere, og skal til det formål
> > følges op af andre tiltag. Hvad angår brugen af stoffet til behandling
> > af narkomaner har jeg sakset følgende fra "patient prescribing
> > information" på
www.vivitriol.com :
> >
> > "Who should not take VIVITROL?
> >
> > Do not take VIVITROL if you:
> >
> > • Are taking or have a physical dependence on opioid-containing
> > medicines. (See "What is
> > the most important information I should know about VIVITROL?")
> >
> > • Use or have a physical dependence on opioid street drugs. (See "What
> > is the most important
> > information I should know about VIVITROL?")
> >
> > • Are allergic to VIVITROL. The active ingredient is naltrexone. See the
> > end of this leaflet for
> > a complete list of ingredients in VIVITROL."
> >
> > - cep
>
> ups, hjemmesiden var self.
www.vivitrol.com
>
> - cep
Det virksomme stof i Vivtrol hedder Naltrexone, her er hvad National
Institute on Drug Abuse/National Institutes of Health skriver og læg
godt mærke til anbefalingernea pkt 2 til sidst skrevet før Vivtrol blev
opfundet:
http://www.nida.nih.gov/MeetSum/naltrexone.html
National Institute on Drug Abuse
National Institutes of Health
Naltrexone
An Antagonist Therapy for Heroin Addiction
November 12-13, 1997
SUMMARY
Betty Tai, Ph.D.
Jack Blaine, M.D.
NIDA Treatment Workgroup
Introduction
Narcotic antagonist pharmacotherapy of opioid addiction was proposed by
Wickler and developed based on the classical behavioral concept of
"extinction." The euphoric effects of opioids which reinforce the
self-administration behavior are blocked when an individual is being
treated with a narcotic antagonist. The repeated lack of reinforcement,
as well as the perceived "fuitility" of using the agonist, will
gradually result in the extinction of opioid self-administration
behavior. Naltrexone is an ideal opioid antagonist treatment medication:
It is a pure, potent mu antagonist that can be taken by mouth once daily
or every other day, and has minimal side effects. It is neither
reinforcing nor addicting and has no potential for abuse or diversion
for unprescribed use. However, patient non-compliance in part due to the
absence of any agonist effects is a common problem. Therefore, a
favorable treatment outcome requires a positive therapeutic
relationship, careful monitoring of medication compliance and effective
behavioral interventions. Many experienced clinicians believe that
naltrexone is most useful for highly motivated recently detoxified
patients who desire total abstinence because of external circumstances.
Other potential target populations are individuals at the experimenting
stage of opioid use, or those who are in early stages of their
addiction.
Background
Naltrexone, a derivative of naloxone is an orally active and long acting
potent pure narcotic antagonist. Clinical pharmacology studies
demonstrated that oral naltrexone at 50, 100 and 150mg effectively
blocks the physiological and subjective effects of parenterally
administered heroin, hydromorphone or morphine for 24, 48 and 72 hours
respectively. Naltrexone is rapidly biotransformed into a less active
metabolite. No change was observed in the rate of naltrexone disposition
during chronic dosing indicating no metabolic induction. Studies showed
the lowest effective plasma naltrexone concentration of 2ng/ml provided
an average of 86.5% blockade of 25mg IV heroin effects. Thus, in sustain
released therapy for opiate antagonist activity, plasma level of
naltrexone should be kept above 2ng/ml. (Veraby, 74)
Initial development of naltrexone as a medication to be marketed for the
treatment of heroin addiction was initiated by the Special Action Office
for Drug Abuse Prevention (SAODAP) in the early 1980s and completed by
NIDA including preclinical toxicology, pharmacokinetics and clinical
studies. No organ toxicity, developmental toxicity or carcinogenicity
were revealed in the preclinical studies. Naltrexone was approved by the
FDA in 1984 on the basis of its pharmacological efficacy as a narcotic
antagonist and its safety profile. Although clinical efficacy data in
the multi-site placebo controlled clinical trial were inconclusive,
naltrexone was superior to placebo in producing less heroin use and more
abstinence in those who tested the naltrexone blockade by using heroin
at least once. In 1995, Naltrexone was approved by the FDA for the new
indication of preventing relapse to alcohol use in formerly dependent
alcoholic patients (Vocci).
Naltrexone has been used together with clonidine to shorten
detoxification from heroin or methadone from two weeks to only one day.
Withdrawal from the opiate is precipitated by naltrexone and resulting
symptoms amerolirated by clonidine. The cost saving for this approach
are substantial compared to use of methadone tapering (Kosten). More
recently, the use of general anesthesia or heavy sedation with medazolam
along with naltrexone has further shortened the detoxification to 4-6
hours. This procedure is sought by patients for reasons such as fear of
withdrawal discomfort; need to shorten the hospital stay, etc (Kleber).
Barriers for Wider Use of Naltrexone
Naltrexone has very few and minor side effects. It is the treatment of
choice in highly motivated patients, especially physicians, nurses,
pharmacists and attorneys (O'Brien). However, clinical experience using
naltrexone for treating opiate addiction has been replete with data on
the poor medication compliance. Ling reported a 6% retention for 60 days
and 2% retention for 9 months in 276 methadone maintained patients who
expressed some interest in trying naltrexone treatment. Another study
with 252 street heroin addicted patients treated with naltrexone had
only 5% retention for 60 days and no retention for 9 months. The main
reason given for this poor treatment retention and low patient
compliance is that naltrexone's lack of agonist activity does not
provide any drug reinforcement when taken and produces no negative
consequences (withdrawal symptoms) when discontinued.
Others have suggested that patients are reluctant to take naltrexone
because of fear of drug related dysphoria or depression. It has been
hypothesized that naltrexone may block the effects of endogenous opiate
peptides and prevent normal endogenous opioid receptor activity involved
in mood modulation producing a subjective state of dysphoria. Animal
laboratory data suggest opioid system up regulation associated with
chronic naltrexone administration. However, a review of clinical studies
using naltrexone treatment for opiate and alcohol dependence showed very
limited occurance of naltrexone-related dysphoria and depression.
(Miotto,1997)
Some physicians report a reluctance to prescribe naltrexone due to the
"black box" warning of liver toxicity in the package insert. The warning
was included based on liver enzyme elevations reported with
100-300mg/day doses of naltrexone during studies of naltrexone treatment
for obesity. A review of literature and adverse effect reports from the
manufacture demonstrated the safety of using 50 mg/day for alcohol or
opiate dependent patients (Galloway).
The lack of wider use of naltrexone by physicians may also be partly due
to the lack of market promotion by the manufacturer resulting in poor
understanding of how and when to use naltrexone. Treatment providers
have not been fully informed about naltrexone's unique role in
facilitating relapse-prevention in opioid addicted patients. An
experienced clinician who has considerable success in naltrexone
treatment of heroin addicts suggested that naltrexone should be viewed
as an adjunct to a wide range of individualized psychobehavioral
treatments which may also include the use of other psychotropic
medications for comorbid mental disorders. Patients families or friends
should be encouraged to participate in treatment planning and compliance
monitoring (Resinick).
Enhancing the Clinical Efficacy
Behavioral therapy, contingency management and a depot formulation have
been proposed as approaches to enhance medication compliance and
retention. When naltrexone (antagonist) treatment is compared and
contrasted with methadone (agonist) treatment, several "obstacles" were
identified contributing to naltrexone's poorer clinical effectiveness.
Behavioral supports were designed to counteract (alleviate) these
shortcomings. For instance, the lack of withdrawal aversion might be
counteracted by increasing the consequences for its discontinuation or
by increase the rewards for compliance to naltrexone's lack of intrinsic
positive reinforcing effects. Counseling should be provided to discuss
anticipated side effects (Rounsville).
Adherence to naltrexone may be augmented by contingency management.
Study results suggested that reinforcement for naltrexone ingestion
increases treatment retention and compliance with naltrexone therapy.
Some schedule of reinforcement appear to produce better compliance with
overall as well as continuous naltrexone intake (Preston).
The development of a sustained-release depot formulation of naltrexone
is ongoing. Current research supports a depot naltrexone which has a
sustained release profile of longer than 20days. Further clinical
testing is needed to evaluate the acceptability, safety and efficacy
(Nuwayser).
Use of Naltrexone in Specific Populations
It has been proposed that Naltrexone treatment should be effective in
highly motivated patients. Suggestions have been raised to test the
feasibility of applying naltrexone treatment in addicted professionals
or in individuals who have entered the criminal justice system.
Physicians Health Programs (PHP) are designed to aid treated individuals
to return to their profession. The program serves dual functions: 1) to
observe, advise and monitor patient compliance with the treatment and
patient abstinence, and 2) to advocate for the recovering physicians'
rights with hospital/group, insurance underwriter and State Licensing
Boards. The PHPs often combine behavioral modification, appropriate
pharmacotherapy, self-help, "tough love," and contingency management, an
approach which has produced excellent outcomes. Few opioid addicted
physicians participating in PHPs are prescribed naltrexone. However, it
does suggest that if naltrexone is to be made acceptable to opioid
addicts with contingency management, the "voucher" must be at least as
reinforcing as the drug of abuse.(Cohen)
Similarly, the Lawyers Counseling Program(LCP) of the DC Bar protects
the lawyer's professional status and assists impaired lawyers seeking
treatment and monitors their treatment progress. The services of LCP
include assessment, referral, monitoring intervention, etc. Data
suggested that 50-75% of the lawyer discipline cases involved addiction.
The success rate is very impressive with this program; 100% abstinence
for at least two years. These programs may provide an opportunity for
the development and utilization of even more effective strategies, such
as naltrexone pharmacotherapy for intervention and treatment (Schwartz).
Treating Federal probationers with naltrexone was studied by the Dr.
O'Brien's group at University of Pennsylvania. Results suggested that
naltrexone treatment reduced the re- incarceration rate by 50%
(Cornish).
Recommendations
Proposals made to enhance the effectiveness and expand the use of
naltrexone in treating heroin addiction included the following:
1. In order to achieve a opioid free state required to start
naltrexone, the detoxification procedure needs to be tailored to assist
transition to naltrexone treatment.
2. To improve medication compliance: Develop long acting delivery
system, such as depot formulation of naltrexone which lasts for up to 30
days to minimize patient decision making; Coadminister naltrexone with
SSRIs or other antidepressant; Add special motivation enhancing
behavioral or psychosocial adjuncts.
3. To expand the use of naltrexone in treatment: Use in special
patient populations with high external motivation to remain drug free
such as impaired professionals, drug-experimenting adolescents,
parolees, probationers, work-release participants. etc.
4. To improve the treatment effectiveness of naltrexone: Educate and
train treatment practioners the correct and effective way of using
naltrexone in treating opioids addicted patients.
--
§ 9 Ved aftalens ophør skal bygningen afleveres i ren- og
ryddeliggjort stand.
- Midlertidig aftale om benyttelse af
Jagtvej 69 fra 1982