WO1992005787A1 - Drug therapy for alcohol abusers - Google Patents
Drug therapy for alcohol abusers Download PDFInfo
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- WO1992005787A1 WO1992005787A1 PCT/US1991/007107 US9107107W WO9205787A1 WO 1992005787 A1 WO1992005787 A1 WO 1992005787A1 US 9107107 W US9107107 W US 9107107W WO 9205787 A1 WO9205787 A1 WO 9205787A1
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- WO
- WIPO (PCT)
- Prior art keywords
- composition
- medication
- habit
- forming
- disulfiram
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
Definitions
- the present invention relates to a method and composition for the treatment of alcoholism. More specifically, the present invention relates to a method that utilizes a composition comprised of two medications to treat alcohol abuse and improve patient compliance with treatment programs. Alcoholism is a severe disease. The deaths of over
- Disulfiram also known as Antabuse
- Antabuse has been widely used since the early 1950's in the treatment of alcoholism.
- Disulfiram causes a strong adverse reaction in a person within five to fifteen minutes after the person has consumed alcohol. Side-effects are believed to be minimal, and life- threatening reactions with or without alcohol are very rare.
- disulfiram therapy has resulted in only modest success in treating alcoholism.
- VA Veterans Administration
- the one-year abstinence rate for patients on disulfiram (18%) was no better than for the control group (20%) , but disulfiram patients had significantly more days of sobriety.
- VA Veterans Administration
- diazepam a member of the benzodiazepine family of somewhat habit- forming, anti-anxiety medications. Diazepam appears to decrease cravings for alcohol. A significant disadvantage, however, with using diazepam is that alcoholics, after only a short period of time, frequently relapse into drinking while continuing to take diazepam. Further treatment of the alcohol abuse is subsequently discontinued.
- the present invention provides a novel and effective composition and/or method for treating alcoholism.
- the present invention utilizes a method that inseparably combines therapeutically effective dosages of two medications, disulfiram or calcium carbamide and a drug that affects the neurological system in a manner similar to alcohol, such as diazepam or librium, into a single composition.
- the single composition can be administered to alcoholics following a brief (usually 12 hour) period of detoxification so as to maintain abstinence from alcohol.
- Use of the combined medication by alcoholics can significantly improved abstinence from alcohol and result in greater compliance with the treatment program.
- the present invention provides a method of treating alcoholics following a period of detoxification.
- the method preferably comprises the steps of administering a composition to an alcoholic comprising a therapeutically effective dosage of disulfiram or calcium carbamide and a benzodiazepine or similar minor tranquilizer or addictive, anti-anxiety medication.
- the dosage comprises 125 mg of disulfiram and 10 mg of diazepam.
- the present invention provides a new treatment for alcoholism, wherein therapeutically effective dosages of disulfiram and a benzodiazepine or related minor tranquilizer or addictive, medication are inseparably combined in a single composition for ingestion by alcoholics.
- Initial studies indicate that, after repeatedly failing other therapeutic approaches, alcoholics that take the combination medication, show significant improvement in abstinence from alcohol and remain in therapy. The marked improvement is attributed to the qualities of the combination medication, which are not evident when each medication is administered separately.
- the four patients who ceased taking the disulfiram were treated with the combination medication of the present invention comprising a single tablet containing 125 mg of disulfiram and 10 mg of diazepam, given twice daily.
- the combination medication of the present invention comprising a single tablet containing 125 mg of disulfiram and 10 mg of diazepam, given twice daily.
- Preliminary results indicate that treatment with the combination medication is markedly better than the treatment with the medications individually. Improvement in sobriety and compliance with therapy was seen in these patients receiving the combination medication.
- the disulfiram-diazepam treatment consists of administering to the average patient a combination capsule or pill containing a standard starting dosage of 125 mg of disulfiram and 10 mg of diazepam.
- the starting dose should be given twice a day with a maximum of four times a day. If given only twice a day, the dosage should be supplemented by the addition of 250 mg of disulfiram once a day, so that the total disulfiram dosage for the first two weeks is a standard 500 mg. After the first two weeks, the recommended dosage of disulfiram is 250 mg daily or the equivalent of two combination capsules or pills per day.
- Dosage preparations of 125 mg of disulfiram combined with either 2 mg or 5 mg of diazepam are recommended for patients who are susceptible to the sedative effects of diazepam. Further, after patients have achieved extended abstinence and stability for a three month to two year period, these weaker preparations should be used in weaning patients off of diazepam.
- the disulfiram-diazepam combination should be administered in conjunction with a comprehensive treatment program, including group and individual therapy and often brief hospitalization or in-patient residential treatment.
- librium in addition to diazepam, librium or other medications including sedatives (e.g., chloral hydrate) and pain medications (e.g., Darvon ® ) could be used.
- sedatives e.g., chloral hydrate
- pain medications e.g., Darvon ®
- the most effective medications are those that are similar to alcohol in their effects on the patient's neurological system.
- capsules of the combination medication have been used, it is contemplated that the medication can be bound in tablet form.
- the present invention involves the various embodiments associated with the combination of disulfiram and a habit-forming or addictive, anti-anxiety drug, such as diazepam, in a single composition and its use in all respects, and is not to be construed as limited to any specific aspect or embodiment except as defined by the lawful scope of the appended claims.
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- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
A novel composition and/or method for the treatment of alcoholism, wherein the composition comprises a therapeutically effective dosage of an agent that induces adverse reactions to alcohol ingestion, e.g. such as disulfiram or calcium carbamide, and a drug that affects the neurological system in a manner similar to alcohol, preferably a habit-forming or addictive drug, e.g. diazepam or librium. The method comprises administering a composition to alcoholics that combines therapeutically effective dosages of the aversive agent disulfiram and a habit-forming or addictive drug into a single composition. Preferably, the habit-forming or addictive medication is an anti-anxiety drug and is a member of the benzodiazepine family. Most preferably, the habit-forming, anti-anxiety drug is diazepam.
Description
S P E C I F I C A T I O N
TITLE: "DRUG THERAPY FOR ALCOHOL ABUSERS"
BACKGROUND OF THE INVENTION The present invention relates to a method and composition for the treatment of alcoholism. More specifically, the present invention relates to a method that utilizes a composition comprised of two medications to treat alcohol abuse and improve patient compliance with treatment programs. Alcoholism is a severe disease. The deaths of over
105,000 Americans each year and over one million persons worldwide are attributed to this disease. Despite the existence of a variety of treatment programs, success rates for treating alcoholism are relatively low, usually in the 20% to 30% range after one year of abstinence.
Yet, even these figures may underestimate the difficulty of treating alcoholism, since many individuals are unwilling to enter into any alcohol treatment program.
The typical treatment of alcoholism has sometimes involved the use of drug therapy. Disulfiram, also known as Antabuse, has been widely used since the early 1950's in the treatment of alcoholism. Disulfiram causes a strong adverse reaction in a person within five to fifteen minutes after the person has consumed alcohol. Side-effects are believed to be minimal, and life- threatening reactions with or without alcohol are very rare. Unfortunately, disulfiram therapy has resulted in only modest success in treating alcoholism. In a recent large scale, multi-center study by the Veterans Administration (VA) , the one-year abstinence rate for patients on disulfiram (18%) was no better than for the control group (20%) , but disulfiram patients had
significantly more days of sobriety. Typically, patients cease taking the disulfiram and discontinue treatment resulting in a relapse in alcohol abuse.
One drug that is commonly used for alcohol detoxification, but not for therapy, is diazepam, a member of the benzodiazepine family of somewhat habit- forming, anti-anxiety medications. Diazepam appears to decrease cravings for alcohol. A significant disadvantage, however, with using diazepam is that alcoholics, after only a short period of time, frequently relapse into drinking while continuing to take diazepam. Further treatment of the alcohol abuse is subsequently discontinued.
Although initially effective, existing pharmacological therapies fail to provide adequate treatment for long-term and severe alcohol abuse. Accordingly, an alternative approach for the treatment of alcoholics would be useful in improving abstinence from alcohol. SUMMARY OF THE INVENTION
The present invention provides a novel and effective composition and/or method for treating alcoholism. To this end, the present invention utilizes a method that inseparably combines therapeutically effective dosages of two medications, disulfiram or calcium carbamide and a drug that affects the neurological system in a manner similar to alcohol, such as diazepam or librium, into a single composition. The single composition can be administered to alcoholics following a brief (usually 12 hour) period of detoxification so as to maintain abstinence from alcohol. Use of the combined medication by alcoholics can significantly improved abstinence from
alcohol and result in greater compliance with the treatment program.
In an embodiment of the present invention, the present invention provides a method of treating alcoholics following a period of detoxification. The method preferably comprises the steps of administering a composition to an alcoholic comprising a therapeutically effective dosage of disulfiram or calcium carbamide and a benzodiazepine or similar minor tranquilizer or addictive, anti-anxiety medication.
In one embodiment of the composition of the present invention, the dosage comprises 125 mg of disulfiram and 10 mg of diazepam.
Additional features and advantages of the present invention are further disclosed and will be apparent from the detailed description of the presently preferred embodiments and accompanying drawings.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS The present invention provides a new treatment for alcoholism, wherein therapeutically effective dosages of disulfiram and a benzodiazepine or related minor tranquilizer or addictive, medication are inseparably combined in a single composition for ingestion by alcoholics. Initial studies indicate that, after repeatedly failing other therapeutic approaches, alcoholics that take the combination medication, show significant improvement in abstinence from alcohol and remain in therapy. The marked improvement is attributed to the qualities of the combination medication, which are not evident when each medication is administered separately. The reinforcing quality of a benzodiazepine medication such as diazepam results in greater compliance
by the alcoholics with the treatment program, i.e., the taking of the composition. But equally as important and vitally necessary, the addition of disulfiram prevents relapse into alcohol abuse. By way of example, and not limitation, the following examples serve to further illustrate the present invention in its preferred embodiments. EXAMPLE 1 - Clinical Studies
Studies were conducted on six patients whose long- term alcohol abuse persisted despite multiple hospitalizations and participation in 28-day treatment programs. Because the combination medication was initially unavailable, the patients were given separate pills of disulfiram and diazepam. Approximately 125 mg of disulfiram and 10 mg of diazepam were administered once or twice a day to each patient.
Within one week, four of the six patients ceased taking the disulfiram. Although they continued taking the diazepam, the patients relapsed into alcohol abuse. Drinking continued while taking the diazepam, thereby creating additional risks for the patients. The fifth patient was given the pills each day by a parent, and the sixth did maintain sobriety.
Subsequently, the four patients who ceased taking the disulfiram were treated with the combination medication of the present invention comprising a single tablet containing 125 mg of disulfiram and 10 mg of diazepam, given twice daily. Preliminary results indicate that treatment with the combination medication is markedly better than the treatment with the medications individually. Improvement in sobriety and compliance with therapy was seen in these patients receiving the combination medication. These patients
continued to abstain from alcohol abuse and currently remain in therapy, results which none had previously achieved with other treatment approaches. Further, there appears to be no adverse reaction with the use of the combination medication, other than minor side-effects which can be alleviated with simple adjustments.
These results suggest that alcoholics benefit from qualities of the combination medications not present in the two medications, when administered separately. Specifically, the reinforcing quality of diazepam appears to facilitate patient compliance in continuing the treatment program, while the disulfiram prevents a relapse into alcohol abuse. In one sense, a patient becomes mildly addicted to "hooked" to the medication by being addicted to the diazepam or other habit-forming drug. However, this addiction is quite easily managed by gradual withdrawal after the alcoholic has achieved sobriety and made lifestyle changes. The mild addiction actually benefits the treatment's success. EXAMPLE 2 - Treatment Dosages and Program
The disulfiram-diazepam treatment consists of administering to the average patient a combination capsule or pill containing a standard starting dosage of 125 mg of disulfiram and 10 mg of diazepam. The starting dose should be given twice a day with a maximum of four times a day. If given only twice a day, the dosage should be supplemented by the addition of 250 mg of disulfiram once a day, so that the total disulfiram dosage for the first two weeks is a standard 500 mg. After the first two weeks, the recommended dosage of disulfiram is 250 mg daily or the equivalent of two combination capsules or pills per day.
Dosage preparations of 125 mg of disulfiram combined with either 2 mg or 5 mg of diazepam are recommended for patients who are susceptible to the sedative effects of diazepam. Further, after patients have achieved extended abstinence and stability for a three month to two year period, these weaker preparations should be used in weaning patients off of diazepam.
Ideally, the disulfiram-diazepam combination should be administered in conjunction with a comprehensive treatment program, including group and individual therapy and often brief hospitalization or in-patient residential treatment.
It is contemplated that in addition to diazepam, librium or other medications including sedatives (e.g., chloral hydrate) and pain medications (e.g., Darvon®) could be used. However, it is likely that the most effective medications are those that are similar to alcohol in their effects on the patient's neurological system. Further, although to date only capsules of the combination medication have been used, it is contemplated that the medication can be bound in tablet form.
The present invention involves the various embodiments associated with the combination of disulfiram and a habit-forming or addictive, anti-anxiety drug, such as diazepam, in a single composition and its use in all respects, and is not to be construed as limited to any specific aspect or embodiment except as defined by the lawful scope of the appended claims.
Claims
1. A method of treating alcoholism comprising the step of: administering a composition to an alcoholic, said composition consisting of a therapeutically effective dosage of an agent that induces adverse reactions to alcohol ingestion and a medication that is similar to alcohol in its affect on the neurological system of the alcoholic.
2. . The method of claim 1, wherein said medication is selected from the group consisting of: sedatives, pain medications, and addictive, anti-anxiety medications.
3. The method of claim 1, wherein said medication is habit-forming.
4. The method of claim 3, wherein said habit- forming medication is an anti-anxiety drug.
5. The method of claim 4, wherein said habit- forming medication is a benzodiazepine-related compound.
6. The method of claim 5, wherein said benzodiazepine-related compound is diazepam.
7. The method of claim 1, wherein said medication is librium.
8. The method of claim 1, wherein said agent is calcium carbamide.
9. The method of claim 1, wherein said composition includes 125 mg of disulfiram.
10. The method of claim 1, wherein said composition includes 10 mg of diazepam.
11. The method of claim 1, wherein the step of administering said composition is undertaken two to four times a day.
12. A method of treating an alcoholic patient following a period of detoxification to encourage abstinence from alcohol, comprising the steps of: providing the alcoholic patient with a therapeutically effective composition of an agent that induces adverse reactions to alcohol ingestion and a medication that is similar to alcohol in its effect on the neurological system; and
reinforcing the alcoholic patient to comply with treatment by the presence of a medication that is similar to alcohol in its effect on the neurological system, whereby the patient desires to ingest the disulfiram and the medication simultaneously.
13. The method of claim 12, wherein said medication is selected from the group consisting of: sedatives, pain medications, and addictive, anti-anxiety medications.
14. The method of claim 12, wherein said medication is habit-forming.
15. The method of claim 14, wherein said habit- forming medication is an anti-anxiety drug.
16. The method of claim 15, wherein said habit- forming medication is a benzodiazepine-related compound.
17. The method of claim 16, wherein said benzodiazepine-related compound is diazepam.
18. The method of claim 12, wherein said medication is librium.
19. The method of claim 12, wherein said agent is calcium carbamide.
20. The method of claim 12, wherein said composition includes 125 mg of disulfiram.
21. The method of claim 12, wherein said composition includes 10 mg of diazepam.
22. The method of claim 12, wherein the step of administering said composition is undertaken two to four times a day.
23. A composition for treating alcoholism comprising: a therapeutically effective dosage of an agent that induces adverse reactions to alcohol ingestion and a medication that is similar to alcohol in its affect on the neurological system.
24. The composition of claim 23, wherein said medication is selected from the group of depressants consisting of: sedatives, pain medications, and addictive, anti-anxiety medications.
25. The composition of claim 23, wherein said medication is habit-forming.
26. The composition of claim 25, wherein said habit-forming medication is an anti-anxiety drug.
27. The composition of claim 26, wherein said habit-forming medication is a benzodiazepine-related compound.
28. The composition of claim 27, wherein said benzodiazepine-related compound is diazepam.
29. The composition of claim 23, wherein said medication is librium.
30. The composition of claim 23, wherein said agent is calcium carbamide.
31. The composition of claim 23, wherein said composition includes 125 mg of disulfiram.
32. The composition of claim 23, wherein said composition includes 10 mg of diazepam.
33. A composition for treatment of alcoholics after a period of sobriety and stability, said composition comprising a therapeutically effective dosage of an agent that indices adverse reactions to alcohol ingestion and a medication that is similar to alcohol in its affect on the neurological system.
34. The composition of claim 33, wherein said medication is selected from the group of depressants consisting of: sedatives, pain medications and additives, anxiety medications.
35. The composition of claim 33, wherein said medication is habit-forming.
36. The composition of claim 35, wherein said habit-forming medication is an anti-anxiety drug.
37. The composition of claim 36, wherein said habit-forming medication is a benzodiazepine-related compound.
38. The compound of claim 37, wherein said benzodiazepine-related compound is diazepam.
39. The composition of claim 33, wherein said medication is librium.
40. The composition of claim 33, wherein said agent is calcium carbamide.
41. The composition of claim 33, wherein said composition includes 125 mg of disulfiram and between 2 mg and 5 mg of diazepam.
42. A composition for inducing alcohol abstinence in a detoxified alcoholic, comprising: an agent that induces adverse reactions to alcohol ingestion and a medication that is similar to alcohol in its affect on the neurological system.
43. The composition of claim 42, wherein said medication is selected from the group of depressants consisting of: sedatives, pain-medications, and addictive, anti-anxiety medications.
44. The composition of claim 42, wherein said medication is habit-forming.
45. The composition of claim 44, wherein said habit-forming medication is an anti-anxiety drug.
46. The composition of claim 44, wherein said habit-forming medication is a benzodiazepine-related compound.
47. The composition of claim 46, wherein said benzodiazepine-related compound is diazepam.
48. The composition of claim 42, wherein said composition includes 125 mg of disulfiram and 10 mg of diazepam.
49. The method of claim 1, wherein said agent is disulfiram.
50. The method of claim 12, wherein said agent is disulfiram.
51. The composition of claim 23, wherein said agent is disulfiram.
52. The composition of claim 33, wherein said agent is disulfiram.
53. The composition of claim 43, wherein said agent s disulfiram.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US591,684 | 1990-10-01 | ||
US07/591,684 US5140032A (en) | 1990-10-01 | 1990-10-01 | Drug therapy for alcohol abusers |
GB9101416.7 | 1991-01-22 | ||
GB9101416A GB2248392A (en) | 1990-10-01 | 1991-01-22 | Composition to combat alcoholism |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1992005787A1 true WO1992005787A1 (en) | 1992-04-16 |
Family
ID=26298312
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1991/007107 WO1992005787A1 (en) | 1990-10-01 | 1991-10-01 | Drug therapy for alcohol abusers |
Country Status (2)
Country | Link |
---|---|
AU (1) | AU8760691A (en) |
WO (1) | WO1992005787A1 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998033493A1 (en) * | 1997-01-31 | 1998-08-06 | Oleg Iliich Epshtein | Alcoholic treatment and homeopathic pharmaceutical product |
WO2004054570A1 (en) * | 2002-12-17 | 2004-07-01 | Purepharm Inc. | Combinations of medicaments comprising an alcohol deterrent for treating alcohol dependence or alcohol abuse |
EP1441708A1 (en) * | 2001-11-05 | 2004-08-04 | Krele Pharmaceuticals LLC | Compositions and methods for increasing compliance with therapies using aldehyde dehydrogenase inhibitors and treating alcoholism |
-
1991
- 1991-10-01 AU AU87606/91A patent/AU8760691A/en not_active Abandoned
- 1991-10-01 WO PCT/US1991/007107 patent/WO1992005787A1/en active Application Filing
Non-Patent Citations (6)
Title |
---|
MACLEAD, S.M. et al., CLIN. PHARMACOL, THER. 24(5): 583-590, 1978, "Interaction of Disulfiram with Benzodiazepines". * |
PEACHEY, J.E. et al., DRUGS 27:171-182, 1984, "The Role of Drugs in the Treatment of Alcoholism". * |
PEACHEY, J.E. et al., PSYCHIAT. CLIN. NORTH AMER 7(4):745-756, 1984, "Pharmacologic Treatment of Chronic Alcoholism". * |
PRESKHORN, S.H. et al., INT'L J. PSYCH IN MED. 17(2):117-131, 1987, "Medical Management of the Depressed Alcoholic Patient". * |
SELLER, E.M. et al., NEW ENG J. MED. 305(21); 1255-1262, 1981, "Drugs to Decrease Alcohol Consumption". * |
SELLERS, E.M. et al., ARZNEIM-FORSCH/DRUG RES. 30(I) 5a; 882-886, 1990, "Differential Effects on Benzodiazepine Disposition by Disulfiram and Ethanol". * |
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1998033493A1 (en) * | 1997-01-31 | 1998-08-06 | Oleg Iliich Epshtein | Alcoholic treatment and homeopathic pharmaceutical product |
EA001493B1 (en) * | 1997-01-31 | 2001-04-23 | Олег Ильич ЭПШТЕЙН | Alcoholic treatment and homeopathic pharmaceutical product |
EP1441708A1 (en) * | 2001-11-05 | 2004-08-04 | Krele Pharmaceuticals LLC | Compositions and methods for increasing compliance with therapies using aldehyde dehydrogenase inhibitors and treating alcoholism |
EP1441708A4 (en) * | 2001-11-05 | 2007-05-23 | Krele Pharmaceuticals Llc | Compositions and methods for increasing compliance with therapies using aldehyde dehydrogenase inhibitors and treating alcoholism |
US8093300B2 (en) | 2001-11-05 | 2012-01-10 | Krele Pharmaceuticals, Inc. | Compositions and methods for increasing compliance with therapies using aldehyde dehydrogenase inhibitors and treating alcoholism |
US8481599B2 (en) | 2001-11-05 | 2013-07-09 | Tonix Pharmaceuticals Inc. | Compositions and methods for increasing compliance with therapies using aldehyde dehydrogenase inhibitors and treating alcoholism |
WO2004054570A1 (en) * | 2002-12-17 | 2004-07-01 | Purepharm Inc. | Combinations of medicaments comprising an alcohol deterrent for treating alcohol dependence or alcohol abuse |
Also Published As
Publication number | Publication date |
---|---|
AU8760691A (en) | 1992-04-28 |
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