Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
1999-11-05
2001-12-25
Criares, Theodore J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S654000, C514S456000, C514S319000, C514S810000, C514S811000, C514S812000
Reexamination Certificate
active
06333357
ABSTRACT:
TECHNICAL FIELD
The invention relates to modification of behavior, particularly habitual or addictive behavior, using a combination of chemotherapeutic assistance and psychological counseling. More specifically, it relates to a three-stage protocol for replacing an undesired habit with a desired one.
BACKGROUND ART
Attempts to alter human behavioral patterns associated with addictions or compulsions are littered with failure. Programs designed to modify such habits as overeating, addiction to narcotics, alcoholism, and smoking are the basis for an industry with a turnover of billions of dollars a year. Some of these programs involve entirely psychological counseling and support. Others employ known chemical agents.
A large number of pharmacological agents that affect behavior is known. Perhaps one of the best known is the combination Fen-Phen used for many years to exert an anorectic effect to treat obesity. This combination of phentermine and fenfluramine was available until recently when the cardiopulmonary side effects of this medicament were considered unacceptable. Both of these components are related to amphetamines and are epinephrine analogs which can be used to combat fatigue and drowsiness. The use of, for example, donepezil to treat the symptoms of Alzheimer's disease is also known. In short, a variety of agents known to affect the central nervous system have been used in various contexts to treat a number of indications related directly or indirectly to behaviors.
At present, however, there appears to be no established treatment that is adaptable generally to replacing undesired behaviors permanently with desired ones. The present invention provides such a protocol.
DISCLOSURE OF THE INVENTION
The invention provides a protocol that can be adapted to replace a behavioral pattern that is ingrained and undesired with a desired one—the desired behavior may include simply avoidance of the undesirable activity. The protocol can be applied to humans and to other mammals. The protocol of the invention can be modified as described herein to treat individuals who are habitual gamblers, smokers, alcoholics, sufferers of incapacitating fatigue, narcotics addicts, and the like. It can also be used to train animals, such as domestic pets. It is a three-stage protocol the length of which will vary with the nature of the subject treated.
The first stage comprises acute treatment with effective amounts of compounds that augment the activity of and generally affect the amine neurotransmitters that are associated with the sympathetic nervous system and which influence implicit memory. This treatment may be supplemented with specific aids as dictated by the condition of the subject; for example, a nicotine patch may be useful where the undesired behavior is smoking.
The second stage involves maintaining chemotherapy with these amine neurotransmitter augmenting compounds but adds a component of psychology/supportive therapy in the case of humans, and training or otherwise effecting or conditioning a behavioral adjustment in the case of nonhuman animals. For nonhuman animals this may involve an indirect intervention, e.g., modifying the behavior of the owner.
The third stage comprises administering an acetylcholinesterase (AChase) inhibitor along with the compounds described above with respect to stages I and II. The third stage mimics the psychological condition of rapid eye movement (REM) sleep.
MODES OF CARRYING OUT THE INVENTION
The subjects for which the invention protocol is intended are human or animal subjects who would be benefited by modification of behavior to overcome what might simply be called a “bad habit.” The habits can be internal or external. An internal habit arises by virtue of repetitive behavior unrelated to a direct metabolic effect of an external agent. An external habit further involves an interaction with an external metabolic agent. External habits include narcotics addiction and smoking; internal habits would be exemplified by gambling and overeating. Of course, external habits may be reinforced by an internal habit mechanism as well. As will be seen, where a habit is internal, stage I treatment consists only of stimulators of the sympathetic nervous system in the form of compounds that stimulate amine neurotransmitters, optionally along with agents to control possible side effects of these drugs in cases where they are needed. For treatment of habits which have an external component, however, the subject is supplied with sufficient amounts of the external substance, or with a specific substitute therefor, to ameliorate withdrawal symptoms.
In general, the habitual behavior is controlled by “implicit memory.” As defined herein, “implicit memory” is the unintentional recall of events or activities that influence behavior. Implicit memory is controlled by amine neurotransmitters, most prominently serotonin, norepinephrine, and dopamine. Implicit memory is brought to bear in behaviors that are permanently available and relatively unconsciously controlled. Exemplary behaviors of this type often include a physical component. Motor skills such as riding a bicycle, skiing, swimming, ice skating and the like, once learned, are essentially permanent. Conscious mechanisms are not required to bring them to recall.
On the other hand, “explicit memory” as defined herein relates to a conscious and deliberate recall of recent events and volitional behavior. In general, this type of memory is controlled by a single neurotransmitter, acetylcholine. In stage III of the protocol described herein, the explicit memory is stimulated along with the implicit memory, thus mimicking the transfer of elements from explicit to implicit memory similar to that which occurs in REM sleep. This transfer, in general, permits replacement of a “good” habit which has been implanted in the explicit memory into the habitual realm of the implicit memory. Thus, the behavior patterns explicitly learned in stage II of the invention protocol are transferred into the implicit memory in stage III.
As set forth above, the method of the invention is a protocol that involves three stages of treatment. The first stage, initial therapy, is designed to activate the implicit memory to make the habitual behavior available for modification. The pharmacological agents useful in this stage are compounds that stimulate amine neurotransmitters of the sympathetic nervous system. In general, these compounds are amines which are related to the three major neurotransmitters, serotonin, norepinephrine, and dopamine. Included among these are compounds related to norepinephrine such as ethylnorepinephrine, metaraninol, tyramine, hydroxyamphetamine, methoxamine, albuterol, metamphetamine, benzphetamine, phenylpropanolamine, phentermine, fenfluramine (Pondamin) and dexfenfluramine (Redux), diethylpropion, phentriazine and phendimetriazine. Preferred among these is a combination of phentermine (Ionamin, Adipex) and fenfluramine (Pondamin).
Also useful in stage I is administration of a selective serotonin reuptake inhibitor (SSRI) such as citalopram (Celexa), fluoxetine HCl (Prozac), fluoxamine maleate (Luvox), paroxetine HCl (Paxil) and sertraline HCl (Zoloft). Also useful are drugs which affect dopamine receptors, such as apomorphine and its derivatives.
The dosage of the compounds administered to stimulate the sympathetic nervous system and implicit memory will depend on the specific pharmacologic agent chosen, the condition of the subject, and the judgment of the physician or veterinarian. However, for the combination of phentermine and fenfluramine, preferred dosage ranges are approximately 10 mg fenfluramine and 15-30 mg of phentermine daily. Typical dosages of citalopram are of the order of 10 mg daily.
In addition to the general implicit memory stimulators of the types set forth above, supplemental medication may also be indicated. Where the subject shows severe dependency, or is desirous of modifying a multiplicity of habits, an adrenergic agonist selective for the &agr;
2
receptor is also desirable. These compo
Be Able, LLC
Criares Theodore J.
Kim Jennifer
Morrison & Foerster / LLP
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