Blackbox(englisch)

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© 2011 www.paradigmenwandel.org in cooperation with www.alkohol-und-baclofen-forum.de

Knowledge has been gathered from ten years of interdisciplinary addiction research as well as from two years of experience of the first German Alcohol and Baclofen Forum. This brochure aims at giving an overview of the present state of treatment methods of addiction, anxiety, and depression.

This „Blackbox“ and the matching „Whitebox“ contain more than forty authentic user reports covering their experiences over a period of 6 to 24 months. They provide a clear picture:

„The End of my Addiction“ remains no longer solely the individual experience of a French cardiologist (O. Ameisen, 2004). Moreover it is the reality as experienced by numerous patients and the doctors who treat them – out of necessity – relying on „off-label-use“.

1.7 million Germans are addicted to alcohol or consume alcohol in a risky fashion. According to recent estimates this causes damage to the national economy roughly 22.5 billion Euro per year (DHS, Deutsche Hauptstelle für Suchtfragen). Every year alcolhol is the cause of 73.000 deaths (BZgA, Bundeszentrale für gesundheitliche Aufklärung).

For more than ten years a paradigm shift in science and research has been observed. Brandnew therapeutic approaches with significantly improved chances of recovery have become possible. Numerous studies with Baclofen that have been carried out since 1994 confirm it to be an effective anti-craving-medication.

Up to now German media have ignored this development. That is why we choose the internet platform to inform about progress that has been made in treating addiction, anxiety, and depression. Our main targets are doctors, therapists, and above all afflicted persons and their relatives.

The end of addiction is no longer utopia – it has come true for an increasing number of patients who have successfully been treated with Baclofen. „Abstinence is by no means any longer the aim of initial treatment of alcohol problems“ (K. Mann and F. Kiefer, 2010).

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10 statements on the mode of effect of Baclofen, as in off-label-use for addiction, anxiety, and depression, as carried out by treating doctors and their patients covering a timeframe of six to 24 months.

Dr. Cornelia WeigelInternal Medicine/Addiction Medicine

Center for Drug Addiction Prevention Giessen

Ulrich HammerlaGeneral Practitioner,Addiction Medicine,

Psychotherapy

Friedrich KreuzederAddiction Counseling / Coaching,

Founder / Administrator www.alkohol-und-baclofen-forum-de

„They are surprised and realize that the indispensability of alcohol that has

accompanied them for their whole life has suddenly disappeared.“

Annie Rapp, Paris(Physician and Psychotherapist)

Dr. Bernd HündersenSociologist, Executive Director

Center for Drug Addiction Prevention Giessen

Dr. Holger BergmannGeneral Practitioner

Prof. Dr. Christian HaasenPsychiatry, Psychotherapy

Addiction Medicine and Researchaltomed-mvz Hamburg

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1 Baclofen is a safe anti-craving-medication 2 Baclofen causes no addiction (shift of addiction)

3 Baclofen is ideally suitable for outpatient therapy 4 Baclofen is suitable for long term therapy

5 Baclofen has few side effects

6 Baclofen can be combined (interaction)

7 Baclofen is an effective anti-craving-medication

8 Baclofen can positively influence depression and anxiety

9 Baclofen enables undisturbed interaction in psychotherapy

10 Baclofen can contribute to „inner quietness“ (calmness)

In

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1 Baclofen is a safe anti-craving-medication

After more than 40 years of using Baclofen in neurology for spasm

relief as part of therapy for Multiple Sclerosis not a single case of death

has been reported.

Well documented complications describe mostly neurological cases

of intrathecal application occurring due to failure of pump systems.

All cases described could be treated well and had no long term

consequence. When treating alcohol addiction the medication is

taken orally.

In one single case Baclofen was used with suicidal intention with

a hundred-fold dosage of 2.5mg. After usual emergency intervention

that attempt also remained without any negative consequences.

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2 Baclofen causes no addiction (shift of addiction)

It is known from user reports that single intakes of Baclofen are

occasionally forgotten. There is a tendency from a higher dosage at the

beginning to clearly lowering the dosage in the long run.

Development of tolerance can be ruled out with great likelihood.

One case has been reported in which a dosage of up to 450 mg was

applied for several months. The following reduction to 125 mg did not result

in the loss of effectiveness.

Some users gradually reduce Baclofen after a couple of months

for various reasons. When craving reappears another series of therapy

can be started without any problem, but then in most cases the earlier

dosage is not exceeded.

2 Baclofen besitzt kein eigenes Abhängigkeitspotenzial

als

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3 Baclofen is ideally suitable for outpatient therapy

Outpatient therapy with Baclofen is the rule, clinical treatment is

only necessary in exceptional cases.

Missuse can be widely ruled out because Baclofen does not lead up

to a significant tolerance. Likewise intoxicating or stimulating effects have

not occurred.

A potentially substitutive effect for alcohol was mentioned in a singular

claim from Sweden without, however, delivering any factual evidence.

Due to the very low price of the medication the interest of in street

trafficking is strictly limited.

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4 Baclofen is suitable for long term therapy

Experience in long term therapy over periods of more than ten years

are available from neurological practice. So far neither mental nor

physical impairments (side effects) have been mentioned.

Having used Baclofen at a dosage of 125 mg/d in the treatment of his

alcoholism for seven years Olivier Ameisen seems to have the longest

experience up to now. He does not see any reason to discontinue (2011).

High effectiveness has been shown in a first study with 132 patients at

Université Descartes, Paris, in 2011. More than 80% of patients who were

treated with Baclofen for more than one year proved highly successful.

The first study was the ideal basis for the currently starting phase-IV-study

(2011/2012) which has been funded by state funds as the first European

study.

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5 Baclofen has few side effects

In the studies that have been published so far, mainly fatigue and

occasionally vertigo are reported. These side effects disappeared after

the first weeks and were described by most patients as tolerable.

Other effects such as loss of libido, dry mouth, sleep disorders, euphoria,

depression, edema, and muscle pain were rare and disappeared after

a period of adaptation. Therefore it is important to individually adapt

and slowly increase the dosage until the desired result is reached.

Termination of therapy due to unbearable side effects has mainly been

ascribed to a lack of individual motivation. In many cases such patients

had been urged by members of their families or by employers to seek

therapy. This problem is well known from conservative withdrawal therapies.

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6 Baclofen can be combined (interaction)

In more than 80% of all cases of alcoholism comorbidities with other

psychiatric diseases are to be expected. The most common previous

illnesses are anxiety disorders, PTSD, and depression. In addition there is

growing evidence of borderline and ADHS.

Interactions with sedating antidepressants may occur resulting in a

boost of effects. Occasionally combinations of Baclofen with psycho-

pharmacological drugs are unavoidable. They should always be handled

by cooperating with an experienced physician or therapist.

The combination with benzodiazepines is always risky. With existing renal

insufficiency tight control is recommended. This also applies to cases of less

than normal lung function.

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7 Baclofen is an effective anti-craving-medication

For the time being Naltrexone and Acamprosate are the only anti craving

medications admitted for the treatment of alcoholism. Studies have shown

that both medications work only slightly better than or just as effective as

placebos.

Naltrexone as well as Acamprosate are inappropriate for long-term use

because a damaging effect on the organs is to be expected. Therefore the

time of usage should be limited to three months. Nalmefene as a successor

to Naltrexone will be admitted in 2012; an up to 50% reduction of the drinking

amount has been defined as the aim of this treatment.

As it seems commonly accepted that even after years of abstinence craving

can lead to a relapse, Baclofen remains the only effective medication currently

available. Because of its good tolerance treatment is only rarely interrupted or

terminated. This may be attributed to its additional mood stabilizing effect.

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8 Baclofen can positively influence depression and anxiety

In more than 66% of user reports on Baclofen a fast reduction of anxiety

and depression is described. Frequently fast improvement or complete

disappearance of symptoms is reported. If the basic pre-morbidity is a

generalized anxiety disorder, symptoms often improve rapidly.

When speaking about alcoholism anxiety and depression are mistakenly

regarded solely as withdrawal symptoms without classifying them as

pre-morbidity. In many cases no anxiety disease has been diagnosed at all.

I told all my doctors: 'I use alcohol as a tranquilliser. If you rid me of anxiety,

I'll stop drinking.' My doctors all told me: 'You're anxious because you drink.

Stop drinking and your anxiety will subside.'

Olivier Ameisen, „The End of My Addiction“

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9 Baclofen enables undisturbed interaction in psychotherapy

Craving makes interaction with the therapist impossible.

Brain activities shown in functional magnetresonance tomography (f MRT)

clearly indicate the effects of craving. The patient is under severe tension and

cannot be reached in such a state.

Sedating, calming medications do suppress craving but – due their effect –

they do not permit interaction.

Under therapy some topics evoke strong emotions and/or stress in patients

triggering craving without the therapist being explicitly and necessarily aware

of this. The patient is forced to spend his total energy to fight off the pressure

of addiction. Under such circumstances any therapy is bound to fail.

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10 Baclofen can contribute to „inner quietness“ (calmness)

Baclofen enhances the effect of gamma-a-Aminobutryc acid (GABA) in the

brain. This transmitter is regarded as the most important „calming, inhibiting“

substance of the central nervous system. After several months of using

Baclofen there is a clear tendency towards a positive state of mind,

perceived as „inner quietness“. In therapeutic settings relaxation techniques

(i.e. autogenic training, Jacobson’s progressive muscle relaxation) are used

of to achieve a quite similar state of mind as with Baclofen.

Such techniques have been resorted to for just a few months or unfortunately

have been administered only occasionally. In situations that appear to be

difficult and stressful to the individual patient the chance of relapsing becomes

much higher.

In such situations Baclofen users temporarily and shortly increase the dosage

and reach the state of „inner quietness“ without much effort-before craving can

trigger off a relapse.

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Background:The enhanced understanding of biological processes in the neurotransmitter system attributes the symptom of alcoholism to a breakdown of inner balance. This results in a completely novel understanding of diseases based on substance addiction. In this context brand-new possibilities for the treatment of anxiety and depression open up (Cryan, Kaupmann, 2005).In particular Baclofen thus far known as muscle relaxant seems to have the potential to restore this balance as an agonist of the GABA-B-receptor. The application of Baclofen has been carried out in neurology for more than 40 years without any significant side-effects. The curative success of the French cardiologist O. Ameisen in alcoholism and co-morbidity with anxiety and dysphoria by self-medication with Baclofen is striking. A change of paradigm in the treatment of alcohol addiction has started. The main objective of treatment is not just abstinence (Uchtenhagen, 2009), but also the suppression of craving. Objective: Treating alcoholism with Baclofen should become a safe option in medical routine. This opens up new facilities in treatment and in the prevention of relapses. Baclofen is part of a successful therapy achieving a craving free state of mind with socially and health compatible consumption of alcohol or content abstinence. The results of several web-based surveys within the “Alkohol-und-Baclofen-Forum” (Rippel, Kreuzeder 2010) founded by affected people, as well as nume-rous practical observations (Müller, Volkmar et al. 2010), seem to justify “off-label-prescription”, especially when considering the cost/benefit ratio and the low success rates of the established forms of therapy.

Results and conclusions: Considering the interindividual difference in dose requirement, Baclofen often allows a quick stop of drinking and - respectively - a reduction of consumption of alcohol up to “complete in-difference”. Influencing common comorbidities such as anxiety and depression positively, leads to an efficient, individualized psychotherapy and improves the ability of self-organization. Weigel C, Kreuzeder FJ (2011): Suchtmedmedizin 13,3, 125-126, Suchttherapie 12, S48-S49, Suchttherapie 12, 4, 190

Literature:Cryan JF, Kaupmann K (2005): Don’t worry `B`happy!: a role for GABAB receptors in anxiety and depression. Trends in Pharmacological Sciences 26, 36-43Ameisen O (2005): Complete and prolonged suppression of symptoms and consequences of alcohol-dependence using high-dose baclofen: a self-case report of a physician. Alcohol and Alcoholism 40, 2, 147-150Uchtenhagen A (2009): Abstinenz als gesellschaftlicher und therapeutischer Leitgedanke. Suchttherapie 10, 75– 80Rippel H, Kreuzeder F (2010) Efficacy of Baclofen in the treatment of alcoholism: http://www.paradigmenwandel.org/Publikationen_files/efficacy%20of%20baclofen.pdfMüller C, Vollmer K, Hein J, Heinz A.(2010): Baclofen zur Behandlung der Alkoholabhängigkeit. Sucht 56 (3-4), 167-174

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Experience reports are to be found in Whiteboxhttp://pdfcast.org/pdf/whitebox

16 typical reports by patients with an experience range between 6 band 26 months in off-label-use and predominantly under supervision of their treating doctors.

Further experience reports in the forum. http://alkohol-und-baclofen-forum.de! ! ! ! ! !