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Title:  Diagnosis and treatment system for reward deficiency syndrome (RDS) and related behaviors

United States Patent:  6,955,873

Issued:  October 18, 2005

Inventors:  Blum; Kenneth (1211 Lost Stone, San Antonio, TX 78258)

Appl. No.:  632838

Filed:  August 4, 2000

Abstract

The present invention relates to a kit and an intervenously administrable preparation, both, with a signal transmitter precursor, an enhancer of precursor uptake, and an inhibitor of neurotransmitter reuptake or signal transmitter catabolism. The kit also contains an appropriate swab for obtaining oral cells suitable for allelic analysis. The intervenous formulation contains similar materials and, in some cases, ethanol. Either the kit composition or the intervenous formulation may be used as guided by a subjects allelic analysis. Collections of particular alleles, especially those relating to neural system are comprehensible in terms of likelihood of success in the administration of an interveinous formulation or ingestion of components of the subject kit.

SUMMARY OF INVENTION

An important aspect of the present invention is a kit comprising a buccal swab for obtaining a subject's DNA sample suitable for analysis of alleles associated with signal-transmitter production, reception or catabolism; and at least one composition comprising at least one of: a signal-transmitter precursor, an enhancer of precursor uptake, and an inhibitor of neurotransmitter reuptake or signal-transmitter catabolism; wherein allelic analysis predicts a likelihood of positive effects of a subjects intake of one or more components of the composition in effective amounts.

In an important aspect, the enhancer is a chromium salt, for example chromium nicotinate or chromium picolinate. Such chromium enhances certain neurotransmitter precursor uptake. In certain important aspects, the present invention involves a signal transmitter which includes' neurotransmitters as a subcategory. Other signal transmitters may be peptide like substances or hormones of various sorts. (Although a preferred signal transmitter is a neurotransmitter). In certain cases the inhibitor of the present invention may be an inhibitor of neurotransmitter reuptake or of various signal transmitter catabolisms. The buccal swab of the present invention is basically a method for a subject to obtain a DNA sample from the subjects oral cavity and send this DNA sample to an analytical lab where certain alleles may be determined. One preferred inhibitor of signal transmitter catabolism is D phenylanine or as it exists in DL phenylanine. Certain signal transmitters, in addition to being neurotransmitters, peptidyl transmitters or peptidyl opiates, may be agents such as nitric oxide or other secondary intercellular messengers.

In an important aspect of the present invention alleles are obtained from DNA samples originating from the subjects buccal swab. The alleles to be analyzed include alleles from the following genes: DAT1 (dopamine transporter), dopamine-beta-hydroxylase, dopamine D1 receptor, dopamine D2 receptor, dopamine D3 receptor, dopamine D4 receptor, dopamine D5 receptor, serotonin HTT, serotonin HTRIA, serotonin TDO2, adrenergic ADRA2A, adrenergic ADRA2C, adrenergic NET, catecholamine metabolizing MAOA, catecholamine metabolizing COMT, GABA-GABRA3, GABA-GABRB3, Canabinoid CNR1, NMDA Receptor NUDAR1, Nicotinic Cholinergic (CHRNA4), enkephalin (PENK), and Adrenergic Receptor (AR).

A kit of the present invention may also include, in addition to a buccal swab, the following:

bulleta) an opiate destruction-inhibiting amount of at least one substance which
bulletinhibits the enzymatic destruction of a neuropeptidyl opiate, said substance being selected from the group consisting of amino acids, peptides, and structural analogues or derivatives thereof;
bulletb) a neurotransmitter synthesis-promoting amount of at least one
bulletneurotransmitter precursor selected from the group consisting of dopamine precursors L-Tyr, L-Phe and L-dopa, serotonin precursors L-Trp and 5-hydroxytryptophan, and gamma amino butyric acid (GABA) precursors L-glutamine, L-glutamic acid, and L-glutamate; and
bulletc) a tryptophan concentration enhancing amount of chromium picolinate or
bulletchromium nicotinate, the amount of said substance and said neurotransmitter precursor and said chromium compound being effective in reducing the subject's RDS behaviors.

An important aspect of the present invention, a tryptophan concentration-enhancing amount of chromium nicotinate or chromium picolinate may be present. This combination now being effective in preventing or reducing a subjects unwanted weight or other RDS behaviors, such as attention deficits disorder, intentional processing or memory deficiency. Further RDS behaviors may include any in the group existing of SUD, Obesity, Smoking, Tourettes Syndrome, ADHD, Schizoid/Avoidant Behavior, Aggression, Posttraumatic stress syndrome, PMS or tobacco use. In certain aspects, composition of the present invention may include a daily dietary composition comprising 32 to 10,000 mg DL-phenylalanine, 5 to 5,000 mg L-tryptophan, 3 to 30,000 mg L-glutamine, and the composition further comprises 1-300 mg pyridoxal-5′-phosphate. When the term excess weight is involved, it is understood that this indicates obesity. In a preferred aspect, the kit involves a composition that comprises a daily dietary consumption of about 460 mg DL-phenylalanine, 25 mg L-tryptophan, 25 mg L-glutamine, and the mixture further comprises 5 mg pyridoxal-5′-phosphate. Allelic analysis may be confirmed by observation of a family history of certain RDS behaviors, this involving or confirming an improved likelihood for successful treatment by consumption of the subject composition in the kit. Various other RDS behaviors such as binge eating and cravings for various sensations are also a subject of the present invention.

In an important aspect of the present invention analysis of alleles are involved such alleles may be, for example D2 TaqI A1, B1, C1 or exon 6-7 haplotype HTR2A-C allele homozygous OB-homozygosity for <208 BP alleles of 1875 dinucleotide repeat polymorphism human chromosome 2 microsatellite polymorphism, APO-D-TaqI 2.2 or 2.7 BP, or OB gene D7S 1875. One most important allele of the present invention is the DRD2A1 allele. In one possible embodiment of the present invention, various key ingredients of the composition may be contained in cyclodextrin, particularly where an interveineous or bolus injection might be part of administrating the composition of the present invention. In certain other aspects, consumption of the composition as described in the kit may be advised when the subject has at least one of the following alleles: D1 (homozygosity of Dde A1) D2 (TaqI A1) D4 (VNTR 2) D5 (dinucleotide 13 alleles range 135-159 BP) DAT1 VNTR (10/10) DβH (TaqI B1 allele). This indicating an improved likelihood for a successful response to the composition parenterally or enterally administered.

Other aspects of RDS behavior include Autism, Tourette's Syndrome or ADHD. In an important aspect, the addition of effect amounts of rhodiola or huberzine add an important aspect to the composition of the present invention. Other RDS behaviors include Pathological gambling and wherein the presence in a subject of at least one of the following alleles: D (homozygosity of Dde A), D (Taq A, B, C), indicates an improved likelihood for a successful response. Such behaviors may also include pathological violence, Schizoid/Avoidant (SAB), Aggression, Anger, Hostility, or Posttraumatic Stress Disorders, wherein the presence in the subject of at least one of the following alleles D (Taq A, B, C, exon), DAT (VNTR/), mNOSIa-homozygosity for ≦ BP allele indicates an improved likelihood for a successful response. In certain cases, the RDS behavior may be PMS wherein the presence of at least one of the following alleles DAT1 VNTR (10/10) D2 TaqI A1, B1, C1, exon 6-7 haplotype, or alleles from the DRD1, DRD2, DRD4, HTT, HTRIA, TDO2, DβH, MAO, COMT, GABRAB, GABRB3, PENk, ADRA2A or ADRA2C genes indicates an improved likelihood for a successful response. Substance abuse disorder; is also an important RDS behavior, potentially treated by the by the present invention.

In another important embodiment, the alleles being detected indicate at least one RDS behavior, and in this case the allele is at least one of DRD1, DRD2, DRD3, DRD4, DRD5, DAT1, MITT, HTRIA, TDO2, DBH, ADRA2A, ADRA2C, NET, MAOA, COMT, GABRA3, GABRB3, CNR1, CNRA4, NMDAR1, PENK, AR, CR", HTRIDβ, HTR2A, HTR2C, interferon-γ, CD8A, or PS1 genes. Various other RDS behaviors are still an aspect of the present invention. These behaviors include mania, OCD, sexual, sleep, grade school behavior, gambling, learning, inattention, ADHD, ADDR, impulsivity, MDE, CD, hyperactivity, phobia, schizoid behavior, general anxiety, somatization, drugs, IV drugs, read, ODD, tics, alcohol, or tobacco use. In an important aspect, the allele being analyzed as pointing to certain RDS behaviors is the ventr polymorphism of the maoa gene as stated in claim 29. Such RDS behavior may be schizoid or avoidant.

Most often important alleles of the present invention include DRD2 gene A1 allele, the DAT1 gene, VNTR 10/10 allele, or the DβH gene B1 allele. Another allele of significance is an increased number of (AAT)n triplet repeats in the CNR1 gene. Other aspects of the present invention involve the figment of RDS behavior that includes drug use, obesity, anxiety, depression, psychoses, hostility, paranoid ideation, obsessive-compulsive behavior, neuroticism and over-conscientiousness. In certain important aspects the kit of the present invention may involve analysis of an allele selected from the group consisting of an increased number of the D7S1873, D7S1875, D7S514 or D7S680 dinucleotide repeats in the OB gene. In an important aspect, the allele detecting is by determining the existence of the D2A1 allele of the DRD2 gene and an allele selected from the group comprising the an increased number of the D7S1873, D7S1875, D7S514 or D7S680 dinucleotide repeats in the OB gene.

In 1999, the present inventor conceived of the idea to develop a novel approach to both diagnose and treat RDS and related behaviors via an integrated, systematic approach involving a number of non-obvious components interacting as a commercially produced kit. The kit consists of a non-invasive buccal swab to diagnose the DNA of a suspected RDS proband (a single or multiple genes); an RDS Diagnostic Inventory Scale; a neutraceutical formula consisting of two parts (the SMART Formula plus a specific herbal remedy for each known RDS subtype behavior, i.e. alcoholism, cocaine dependence, smoking behavior, carbohydrate binging, PMS, PMDD, PTSD, ADD, ADHD, pathological gambling, episodic dyscontrol, sexual addiction etc.)

The invention first provides a composition for the treatment of Reward Deficiency Syndrome (RDS) behaviors in a subject. In certain aspects, this composition includes at least one of the following components: an opiate destruction-inhibiting amount of at least one substance which inhibits the enzymatic destruction of a neuropeptidyl opiate, the substance being either amino acids, peptides, and structural analogues or derivatives thereof; a neurotransmitter synthesis-promoting amount of at least one neurotransmitter precursor, the neurotransmitter precursor being either a dopamine precursor such as L-Tyr, L-Phe and L-dopa, a serotonin precursor such as L-Trp and 5-hydroxytryptophan, or a gamma amino butyric acid (GABA) precursor such as L-glutamine, L-glutamic acid, and L-glutamate; a tryptophan concentration enhancing amount of chromium picolinate or chromium nicotinate; a compound that releases enkephaline, the enkephaline releaser being, but not limited to, a peptide, and preferably a D-amino acid containing peptide; or an opiate antagonist amount of at least one compound which blocks the effects of an opiate at either the delta, mu, kappa, sigma, or epsilon receptors. The type of enkephalinase inhibitors, the neurotransmitter precursor, opiate destruction-inhibiting substance, opiate antagonist, and/or the chromium compound, in addition to the compounds specifically listed above, are further described herein this application and are encompassed by this invention. In certain preferred aspects of the invention, the composition is used in preventing or reducing a subject's unwanted weight. In certain other aspects of the invention, the composition is preferably used in the treatment of Attention Deficits Disorder, attentional processing or memory. In this embodiment, for the treatment of Attention Deficits Disorder, Attention-Deficit-Hyperactivity Disorder (ADH D) attentional processing or memory, the composition more preferably includes a neurotransmitter synthesis promoting amount of at least one neurotransmitter promoting substance selected from the group Rhodila or Hubazine or any substance known to enhance the functional amount of the neurotransmitter. As used herein, "derivative" may refer to a chemically modified compound, and analog refers to a different compound that is similar properties or structure to the compound it is being compared.

In certain embodiments of the invention, this composition may be used in the treatment of all RDS related behaviors disclosed herein. RDS behaviors are those behaviors related to a chemical imbalance manifests itself as one or more behavioral disorders related to an individual's feeling of well-being with anxiety, anger or a craving for a substance. RDS behaviors include, alcoholism, SUD, smoking, BMI or obesity, pathological gambling, carbohydrate binging, axis 11 diagnosis, SAB, ADD/ADHD, CD, TS, family history of SUD, and Obesity.

The invention also provides a method of treating a subject for RDS behaviors, including but not limited to SUD, Obesity, Smoking, Tourettes Syndrome, ADHD, Schizoid/Avoidant Behavior, Aggression, Posttraumatic stress syndrome, PMS or tobacco use. RDS behaviors are not specifically limited to these disorders, as many types of sub-disorders are encompassed by these conditions. For example, Attention Deficit Hyperactivity Disorder (ADHD) may manifest itself as alcohol, drugs, obsessive compulsive behaviors, learning disorders, reading problems, gambling, manic symptoms, phobias, panic attacks, oppositional defiant behavior, conduct disorder, academic problems in grade school, smoking, sexual behaviors, schizoid, somatization, depression, sleep disorders, general anxiety, stuttering, and tics disorders. All these behaviors, and others described herein as associated with RDS behaviors or genes involved in the neurological pathways related to RDS, are included as RDS behaviors as part of this invention. Additionally, many of the clinical terms used herein for many specific disorders that are RDS disorders are found in the Quick Reference to the Diagnostic Criteria From DSM-IV, The American Psychiatric Association, Washington, D.C., 1994, 358 pages. Specific disorders whose definitions can be found in this reference, and their code numbers within the DSM-IV include Anxiety disorders, include Panic Disorder Without Agoraphobia, 300.01, Panic Disorder With Agoraphobia, 300.21, Agoraphobia Without History of Panic Disorder, 300.22, Specific Phobia, 300.29, Social Phobia, 300.23, Obsessive-Compulsive Disorder, 300.3, Posttraumatic Stress Disorder, 309.81, Acute Stress Disorder, 308.3, Generalized Anxiety Disorder, 300.02, Overanxious Disorder of Childhood, 300.02, Anxiety Disorder Due to [Indicate general medical condition], 293.89, Substance Induced Anxiety Disorder, 293.89, Anxiety Disorder NOS, 300.00; Attention Deficit and Disruptive Behavior Disorders, including Attention-Deficit/Hyperactivity Disorder, Predominately Inattentive Type, 314.00, Attention-Deficit/Hyperactivity Disorder, Predominately Hyperactivity-Impulsive Type, 314.01 Attention-Deficit/Hyperactivity Disorder, Combined Type, 314.01, Attention-Deficit/Hyperactivity Disorder NOS, 314.9, Conduct Disorder, 312.8 Oppositional Defiant Disorder, 313.81, Disruptive Behavior Disorder NOS, 312.9; Bipolar Disorders including Bipolar I Disorder, 296.0, 296.40, 296.4, 296.6, 296.5, and 296.7, Bipolar II. Disorder, 296.89, Cyclothymic Disorder, 301.13, Bipolar Disorder NOS, 296.80; Depressive Disorders including Major Depressive Disorder, Recurrent, 296.3, Dysthymic Disorder, 300.4, Depressive Disorder NOS, 311, Major Depressive Disorder, Single Episode, 296.2; Eating Disorders including Bulimia Nervosa, Nonpurging Type, 307.51, Bulimia Nervosa, Purging Type, 307.51, Anorexia Nervosa, 307.1, Eating Disorder NOS 307.50; Impulse Control Disorders including Intermittent Explosive Disorder, 312.34, Kleptomania, 312.32, Pyromania, 312.23, Pathological Gambling, 312.31, Trichotillomania, 312.39, Impulse Control Disorder NOS, 312.30; Personality Disorders including Antisocial Personality Disorder, 301.7, Avoidant Personality Disorder, 301.82, Obsessive-Compulsive Personality Disorder, 301.4, Schizoid Personality Disorder, 301.20; Schizophrenia including Paranoid Type, 295.30, Disorganized Type, 295.10, Catatonic Type, 295.20, Undifferentiated Type, 295.90, Residual Type, 295.60, Schizoaffective Disorder, 295.70, Schizophreniform Disorder, 295.40; Sleep Disorders including Primary Sleep Disorders such as Dyssomnias, which include Primary Insomnia 307.42, Primary Hypersomnia 307.44, Narcolepsy 347, Circadian Rhythm Sleep Disorder, 307.45, Dyssomnia NOS 307.47, Parasomnias which include Nightmare Disorder 307.47, Sleep Terror Disorder 307.46, Sleepwalking Disorder 307.46, Parasomnia NOS 307.47, Sleep Disorders Related to Another Mental Disorder which include insomnia related to [Indicate Axis I or Axis H disorder] 307.42, Hypersomnia related to [Indicate Axis I or Axis II disorder] 307.44, Other Sleep Disorders which include Sleep Disorder due to [Indicate the General Medical Condition] 780.xx, Substance Induced Sleep Disorder 78o.xx; Substance Use Disorders including Alcohol Related Disorders such as Alcohol-Induced Psychotic Disorder, with delusions, 291.5, Alcohol Abuse, 305.00, Alcohol Intoxication, 303.00, Alcohol Withdrawal, 291.8, Alcohol Intoxication Delirium, 291.0, Alcohol Withdrawal Delirium, 291.0, Alcohol-Induced Persisting Dementia, 291.2, Alcohol-Induced Persisting Amnestic Disorder, 291.1, Alcohol Dependence, 303.90, Alcohol-Induced Psychotic Disorder, with hallucinations, 291.3, Alcohol-Induced Mood Disorder, 291.8, Alcohol-Induced Anxiety Disorder, 291.8, Alcohol-Induced Sexual Dysfunction, 291.8, Alcohol-Induced Sleep Disorder, 291.8, Alcohol-Related Disorder NOS, 291.9, Alcohol Intoxication, 303.00, Alcohol Withdrawal, 291.8, Nicotine Related Disorders which include Nicotine Dependence, 305.10, Nicotine Withdrawal, 292.0, Nicotine-Related Disorder NOS, 292.9, Amphetamine Related Disorders which include Amphetamine Dependence, 304.40, Amphetamine Abuse, 305.70, Amphetamine Intoxication, 292.89, Amphetamine Withdrawal, 292.0, Amphetamine Intoxication Delirium, 292.81, Amphetamine-Induced Psychotic Disorder with delusions, 292.11, Amphetamine-Induced Psychotic Disorders with hallucinations, 292.12, Amphetamine-Induced Mood Disorder, 292.84, Amphetamine-Induced Anxiety Disorder, 292.89, Amphetamine-Induced Sexual Dysfunction, 292.89, Amphetamine-Induced Sleep Disorder, 292.89, Amphetamine Related Disorder NOS, 292.9, Amphetamine Intoxication, 292.89, Amphetamine Withdrawal, 292.0, Cannabis Related Disorders which include Cannabis Dependence, 304.30, Cannabis Abuse, 305.20, Cannabis. Intoxication, 292.89, Cannabis Intoxication Delirium, 292.81, Cannabis-Induced Psychotic Disorder, with delusions, 292.11, Cannabis-Induced Psychotic Disorder with hallucinations, 292.12, Cannabis-Induced Anxiety Disorder, 292.89, Cannabis Related Disorder NOS, 292.9, Cannabis Intoxication, 292.89, Cocaine Related Disorders which include Cocaine Dependence, 304.20, Cocaine Abuse, 305.60, Cocaine Intoxication, 292.89, Cocaine Withdrawal, 292.0, Cocaine Intoxication Delirium, 292.81, Cocaine-Induced Psychotic Disorder with delusions, 292.11, Cocaine-Induced Psychotic Disorders with hallucinations, 292.12, Cocaine-Induced. Mood Disorder, 292.84, Cocaine-Induced Anxiety Disorder, 292.89, Cocaine-Induced Sexual Dysfunction, 292.89, Cocaine-Induced Sleep Disorder, 292.89, Cocaine Related Disorder NOS, 292.9, Cocaine Intoxication, 292.89, Cocaine Withdrawal, 292.0; Hallucinogen Use Disorders which include Hallucinogen Dependence, 304.50, Hallucinogen Abuse, 305.30, Hallucinogen Intoxication, 292.89, Hallucinogen Withdrawal, 292.0, Hallucinogen Intoxication Delirium, 292.81, Hallucinogen-Induced Psychotic Disorder with delusions, 292.11, Hallucinogen-Induced Psychotic Disorders with hallucinations, 292.12, Hallucinogen-Induced Mood Disorder, 292.84, Hallucinogen-Induced Anxiety Disorder, 292.89, Hallucinogen-Induced Sexual Dysfunction, 292.89, Hallucinogen-Induced Sleep Disorder, 292.89, Hallucinogen Related Disorder NOS, 292.9, Hallucinogen Intoxication, 292.89, Hallucinogen Persisting Perception Disorder (Flashbacks), 292.89; Inhalant Related Disorders which include Inhalant Dependence, 304.60, Inhalant Abuse, 305.90, Inhalant Intoxication, 292.89, Inhalant Intoxication Delirium, 292.81, Inhalant-Induced Psychotic Disorder, with delusions, 292.11, Inhalant-Induced Psychotic Disorder with hallucinations, 292.12, Inhalant-Induced Anxiety Disorder, 292.89, Inhalant Related Disorder NOS, 292.9, Inhalant Intoxication, 292.89; Opioid Related Disorders which include Opioid Dependence, 304.00, Opioid Abuse, 305.50, Opioid Intoxication, 292.89, Opioid Intoxication Delirium, 292.81, Opioid-induced Psychotic Disorder, with delusions, 292.11, Opioid-Induced Psychotic Disorder with hallucinations, 292.12, Opioid-induced Anxiety Disorder, 292.89, Opioid Related Disorder NOS, 292.9, Opioid Intoxication, 292.89, Opioid Withdrawal, 292.0; Polysubstance Related Disorders which include Polysubstance Dependence, 304.80; Tic Disorders which include Tourettes Disorder, 307.23, Chronic Motor or Vocal Tic Disorder 307.22, Transient Tic Disorder 307.21, Tic Disorder NOS 307.20, Stuttering 307.0, Autistic Disorder, 299.00, and Somatization Disorder 300.81. Additionally, other RDS disorders are defined as would be known to one of skill in the art, such as Novelty Seeking, defined in (Clonigen et al., 1993). Other disorders, if not specifically defined herein, are the same as commonly known to one of skill in the art, including common abbreviations. The second part of the invention includes but not limited the following genes: DRD1, DRD2, DRD5, DATI, HTT HTR IA, TDO2, DBH, ADRA 2A, ADRA2C, NET, MAQA, COMT, GABRA3, GABRB3, CNRI, CNRA4, NMDAR1, PENK, AR, CRF, DRD3, DRD4. HTRIDI3, HTR2A, HTR2C, interferon-y, CD8A, PSi, TDO2, HTT, APOE. The third part of the patent is to include an RDS Inventory Scale. The fourth part of the patent involves the SYNERGENE Neutralife product line and includes the following information which relates to the brain reward cascade, the Reward Deficiency Syndrome and both nutraceuticals.

 

Claim 1 of 33 Claims

1. A kit comprising a buccal swab suitable to obtain a subject's DNA sample for allelic analysis; and a composition for the treatment of RDS behaviors in a subject, the composition comprising:

a) an opiate destruction-inhibiting amount of at least one substance which inhibits the enzymatic destruction of a neuropeptidyl opiate, said substance being selected from the group consisting of amino acids, peptides, and structural analogues or derivatives thereof;

b) a neurotransmitter synthesis-promoting amount of at least one neurotransmitter precursor selected from the group consisting of dopamine precursors L-Tyr, L-Phe and L-dopa, serotonin precursors L-Trp and 5-hydroxytryptophan, and gamma amino butyric acid (GABA) precursors L-glutamine, L-glutamic acid, and L-glutamate; and

c) a tryptophan concentration enhancing amount of chromium picolinate or chromium nicotinate, the amount of said substance and said neurotransmitter precursor and said chromium compound being effective in reducing the subject's RDS behaviors; and

d) a neurotransmitter synthesis-promoting amount of at least one neurotransmitter synthesis promoting substance selected from the group consisting of Rhodiola and huberzine, wherein the amount of said substance and said neurotransmitter precursor and said chromium compound being chosen so that the composition is effective in reducing the Attention Deficits disorder, attentional processing, or memory.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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