WO2001000202A1 - Use of fluoxetine, paroxetine and other srsi as medicaments for increasing the capacity to refrain from consuming substances or having activities which create dependence - Google Patents

Abstract

The invention relates to the use of fluoxetine, paroxetine and other serotonine recapture selective inhibitors (SRSI) as medicaments to increase the capacity to refrain from taking substances (alcohol, tobacco, heroin, etc) or having activities which create dependence.

Description

 TITLE: USE OF FLUOXETINE, PAROXETINE AND OTHER SSRIs AS

MEDICINES TO INCREASE THE ABILITY TO WITHDRAW FROM

SUBSTANCES OR ACTIVITIES THAT CREATE DEPENDENCE.

DESCRIPTION

SECTOR OF THE TECHNIQUE

Fluoxetine, paroxetine _^ sertraline, fluvoxamine, etc., in general called selective serotonin reuptake inhibitors (SSRIs) are medicinal substances that have been used so far in the treatment of psychological disorders such as: depressive disorders, obsessive-compulsive, for anguish or bulimia nervosa.

Some of their commercial names are: Seroxat, Prozac, Adoféπ, Reneuron, etc.

The present invention exposes a new mode of use, which refers to the application of these drugs in substance addiction disorders or in process addictions (activities or people), such as gambling, work addiction, money , to shopping, to power, to food - a disorder other than bulimia nervosa -, to sex, or the destructive dependence of another or other people, such as in addiction to sects, among others.

STATE OF THE TECHNIQUE

Until now, psychological techniques have been used to achieve the maintenance of substance abstinence or activities that have created an addiction. These are techniques derived from psychoanalysis, cognitive behavioral therapy, or systemic cutting therapy. At the same time, these patients are provided with social, health and occupational care.

Health care has consisted, above all, in the review of the state of health, medical follow-up, or the prescription of substances for the treatment of psychological disorders or diseases associated with addictions. On the other hand, in the treatments for opioid addiction, naltrexone or naloxoaa is often administered, so that the patient does not feel the effects of the substance if he consumes it and, therefore, stops doing so.

In the case of alcohol, recently, naltrexone or another substance called acamprosate has also been administered, which decreases the desire for consumption to a medium degree.

Methadone or LAAM, substances prescribed in many treatments to habitual opioid consumers, does not diminish the desire for consumption, but rather, as they are opioid agonists, they work as a substitute for them.

SSRIs have been used occasionally when associated anxiety or depression disorders appear in patients.

However, SSRIs have never been used to treat psychological dependence (which we consider equivalent to obsession) in the long term and thus avoid relapses. In fact, until now, the treatment of dependence is not among its indications.

EXPLANATION

Based on research and clinical experience, the author has verified that addictions or dependencies have a series of characteristics similar to those of obsessions. By addictions we understand:

- substance addictions - legal or illegal - such as heroin, alcohol, tobacco, cocaine, hashish, ecstasy, amphetamines, etc.

- process addictions, which can be classified into two sections:

1. addictions to activities, such as shopping, work, television, money, power, sex, internet, etc.

2. Addictions to people, as in the pathological dependence of other people, in dependence on destructive sects, or in the so-called "mor addiction", etc.

In short, we are referring to any type of addiction or dependence. This discovery occurred, fundamentally, following an investigation carried out by the author.

It studied the psychological conflicts of the parents of addicts. The previous hypothesis was that the personality of the parents influenced that of the children and, therefore, could be related to the appearance of dependencies on members of the next generation; they wanted to discover the factors that could be related to the appearance of these dependencies.

For this purpose, thirty-six parents (23 women and 13 men; 11 marriages) of addicts to different substances and processes were applied the MCMI-II test (Millon-II Multiaxial Clinical Inventory) that evaluates personality disorders and clinical syndromes; as a complement, several semi-structured interviews were carried out.

Million II is one of the most powerful and best founded tests that exist today. Their results are based on the study of very large clinical populations in the United States. The disorders are defined according to the manuals of the American Psychiatric Association, DSMHI and DSM-IV, in whose elaboration the author is one of the main collaborators. This manual is the most widely used among mental health professionals worldwide.

A statistically significant elevation of three personality disorders was found: dependent, schizoid and obsessive; specifically, obsessive-compulsive personality disorder, was the one found in a higher number of subjects, specifically in 89% of the sample (77% in men and 96% in women), a significantly higher percentage in both sexes, with a risk of negligible error, not only in the general population but also in the clinical population studied by Millón.

From these striking results, making a conceptual leap, we begin to consider the similarity between obsessive-compulsive disorder and addictions, verifying that addictions - be it substances or processes - have characteristics similar to those presented by the obsessive disorder- compulsive. The drug addict, for example, shows a continuous obsession with the substance and the compulsion to consume it; the shopping addict shows the obsession to buy, and the compulsion to make the purchase, etc. Since selective serotonin reuptake inhibitors (SSRIs) are used successfully to treat obsessive compulsive disorder, the author considers that these medications would have the effect of decreasing the obsessive desire of people who are trying to stay abstinent from a substance or who They are trying to control any type of dependency and, therefore, increase their ability to carry out their purpose.

Obviously we are referring especially to psychological dependence (not only to physical dependence), which is in very prolonged periods (it could be said that. A lifetime) and that is what causes most relapses, one of the problems difficult that addicts face.

It should be clarified that addictions can have a double aspect: physical dependence and psychological dependence. Psychological dependence occurs in all addictions. Physical dependence, when it exists, remits after withdrawal syndrome; Not so psychological dependence. Physical dependence occurs, fundamentally, in some of the substance addictions and is very striking in the case of alcohol or heroin. The detoxification process, carried out under the right conditions, is not particularly difficult. In the same way, in addictions that occur only with psychological dependence, it is not excessively difficult to achieve the cessation of activity. The extraordinary problem is that abstinence be maintained forever or simply for prolonged periods.

The most serious problem of any addiction is, therefore, relapses. These occur easily within a short time after starting treatment (days, weeks or a few months) and in more fortunate cases, after a longer period, one or two years. Few are the subjects who manage to stay abstinent longer - sometimes with enormous personal costs, such as staying in therapeutic communities for years - and even these, it is not uncommon for them to relapse after several years. A minimum percentage manages to abandon their habit for a lifetime.

Relapses do not occur once, if not repeated over and over again, leading to addicts that we can conceptualize as highly motivated, given the number of treatments they undertake, to despair, given the proven uselessness of their numerous attempts. Even more, the addict gradually deteriorates in all areas: personal (physical health and mental), labor, social, family and this deterioration makes it increasingly difficult to achieve abstinence.

By the way, this same process occurs in the obsessive-compulsive subject. He also tries to abandon his obsession / habit and habit over and over again and in many cases he ends up giving in to them by proving the futility of his attempts. This is described, for example, by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, IV, of the American Psychiatric Association) The SSRIs have greatly improved this situation.

So far, no truly effective method has been found to prevent and prevent relapses. The methods used (a combination of medical, psychological, occupational and social techniques) are achieved with great effort by the addict and often by people who certain periods of withdrawal, as we have said, surround him, as well as the therapeutic team. In a truly motivated subject, with personal and social support, treatment is usually more successful. For the subject it is usually a great personal effort, that is, abstinence is expensive, since it implies overcoming a great void, which is the one that leaves the absence of the habit, and controlling high anxiety, as well as facing all kinds of problems that its dependence has accumulated (debts, deterioration of relations, labor deterioration, etc.). After this effort, as we have already said, you can easily find yourself - against your will - with a relapse (this last concept is important. Relapses do not depend on the will of the subject in most cases. The strength of addiction - of obsession - it is superior to human will). The subject, verifying that, despite his suffering and effort to achieve abstinence, falls again and again, logically, he is giving up to addiction.

The use we propose is primarily aimed at preventing and preventing relapse. We believe that the use of fluoxetine or paroxetine, would have a much greater power than the few substances used so far to decrease desire and that, on the other hand, its use could be extended to a greater number of addictions. On the other hand, it would come to reinforce the psychological, social, occupational techniques, etc., used so far. In some cases the possible capacity of SSRIs to treat substance addictions (not process addictions, except in the case of pathological gambling) has already been mentioned.

- For example, its use in animal experiments has been mentioned; but in animals it is not possible for psychological dependence to manifest itself as it does in human beings.

- In other cases they have been considered adequate to alleviate the depressive and anxious processes that occur in some subjects after the abandonment of a drug dependence.

But in no case has the new factor that we now expose been taken into account: the equivalence of psychological dependence and obsessive processes. This is one of the key ideas of our invention. The consideration of this equivalence is what leads to a new way of understanding addictions - all addictions - and therefore to a new way of understanding the treatment that had not been contemplated until now.

Regardless of what was mentioned in the previous paragraph, the use of SSRIs for a long time (at least more than a year and a half in most cases) has not been considered as a way to prevent relapse.

In fact, currently, in the treatment of addictions, the use of SSRIs is only considered as palliative for the anxious or depressive processes that some patients may suffer.

We postulate the use of SSRIs for very long periods, since psychological dependence, according to current knowledge, seems to last a lifetime, in high doses (at least equal to those used in an obsessive-compulsive disorder), with with a view to facilitating the maintenance of abstinence (due to its power to diminish the obsessive desire), to prolong it and, consequently, to avoid relapses.

All these ideas are exposed in detail in several works that we propose to publish in the future:

- Peña, C. "Generational transmission of psychological conflicts. A case of alcoholism." Rev. Clínica y Salud, Official College of Psychologists of Madrid, Madrid, (in press), where the treatment of a woman with a controlled beverage program is presented in detail (the most difficult to carry out in addictions, because it implies, not complete abstinence, if not the control of the habit), in which SSRIs were used in combination with other techniques.

- Peña, C. "Study of psychological conflicts in parents of addicts. Compulsive, schizoid and dependent personality disorders. Some implications for therapy and prevention" Rev. Clínica y Salud, Official College of Psychologists of Madrid, Madrid, (in press), in which the research work on which we rely is fully exposed.

- Peña, C. "Relationship between addictions and obsessive-compulsive disorders s. Use of SSRIs in the treatment of addictions", which sets out in detail the relationship between both disorders and the coincidence of their characteristics.

As a final point we want to highlight that, in sum, the improvements that our invention introduces lie, fundamentally, in three concepts:

1. The use of SSRIs in all types of addictions, for prolonged periods, in order to prevent relapse.

2. The use of SSRIs in process addictions.

3. The idea of the similarity between obsessive-compulsive disorder (OCD) and psychological dependence, which leads to a new way of understanding addictions and, therefore, to new ways of approaching treatment.

MODE OF REALIZATION

Probably the severity of psychological dependence in addictions is greater than that of obsessions, since in addiction a greater reinforcement is obtained, at least in the initial stages, provided by a substance, an activity or a person or a group of persons.

That is to say, just as in the obsessions an anxiety relief is obtained, however in the addictions it is obtained, not only that relief, but also an external reinforcement, although in the end that reinforcement disappears completely when being overcome by the “punishment "derived from addictive activities (personal, family, social, work, or health problems) and due to the effect of" accustoming ", so that the addict, after a certain time, no longer takes pleasure from his habit. With all this we want to point out that it is possible that the The dose needed by an addict is greater than that needed by a patient with obsessive-compulsive disorder.

As for the necessary time of taking the medication, it is not easy to determine a priori and in all cases; we could say that it is undefined, since psychological dependence lasts a lifetime, that is, at the moment when the addict returns to "get closer" to the object of his addiction, it falls. For example, a smoker who has quit tobacco and has not consumed for several years, if he returns to smoke, although in principle it is only a cigarette or a few puffs, will fall; or an alcoholic, habitual whiskey drinker will relapse even if he only starts drinking beer "without alcohol" (in our country, except one brand, all have 0.1 degrees).

The treatment time, therefore, should be established according to experience and according to the addict in particular evaluated by a team of professionals. There are alcoholics or heroin addicts who relapse after a period of ten years, for example of abstinence; but unfortunately, the most common is that they do so in the first or first years after having started abstinence. Therefore, for the moment we can consider that any treatment with SSRIs should last at least a year and a half to three; If abstinence is ongoing, intermittent periods of life-long treatment, such as prevention, may be appropriate. Possibly, in many cases the necessary period of intake is longer.

In general we can say that the drug would be used in doses of 40 milligrams / day in the case of fluoxetine or paroxetine - which is the dose indicated for obsessions -, or more, depending on the severity of the addiction, for a time prolonged (as in obsessive-compulsive disorders). In the case of fluvoxamine, sertraline, etc., the doses in milligrams are different; We will always be guided by the one indicated for obsessive-compulsive disorder.

This medication would not exclude in any case the use of the psychological, social, occupational or sanitary techniques that are usually carried out to achieve the full recovery of the addict.

Finally, it is necessary to warn that for the use of the drug to be effective, the condition of withdrawal must occur, that is, the addict must overcome the syndrome of Withdrawal or stop the addictive activity or process completely. Taking into account that the SSRIs take a few weeks to take effect, it will be advisable to start the shot before the moment when it has been decided to start abstinence.

Claims

CLAIMS USE OF FLUOXETLNA, PAROXETINA AND OTHER SSRIs AS MEDICATIONS TO INCREASE THE ABILITY TO SUBSTANCE FROM SUBSTANCES OR ACTIVITIES THAT CREATE DEPENDENCE.

1. Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, paroxetine, fluvoxamine, sertraline, etc. they have the ability to decrease obsessions to a high degree; Since it has been proven, from our clinical experience and research that drug addiction and other dependencies have characteristics that are very similar to obsessions, we consider that these substances can be used in a new way: to increase the capacity of people to abstain from toxic or activities that have caused them a dependency, thus increasing the withdrawal time achieved in current treatments and avoiding relapses.

1.1. Within the concept of "addiction" we include:

- substance addictions - legal or illegal - such as heroin, alcohol, tobacco, cocaine, hashish, ecstasy, amphetamines, etc.

- process addictions, which can be classified into two sections: a) addictions to activities, such as shopping, work, television, money, power, sex, internet, etc. b) addictions to people , as in the pathological dependence of other people, in the dependence on destructive sects, etc.

1.2. The improvements of the present invention consist of: a) The use of SSRIs in all types of addictions, for very long times, in order to prevent relapse. b) The use of SSRIs in process addictions. c) The idea of the similarity between obsessive-compulsive disorder (OCD) and psychological dependence, which leads to a new way of understanding addictions and, therefore, to new ways of approaching treatment.

1.3. The treatment would be performed using, at a minimum, doses equivalent to those used in obsessive-compulsive disorder, for prolonged periods.