Vigabatrin for Treatment of Cocaine Dependence
Clinical Trial Title:
Randomized, Double-Blind, Placebo-Controlled Trial of Vigabatrin for the Treatment of Cocaine Dependence in Mexican Parolees
Background & Study Purpose:
Cocaine dependence is an impulsive desire that arises in drug addicts. Medically and psychologically its effects are severe in a drug addict. Cocaine is a sedative drug which causes brain damage and nervous blockage which results in heart attacks, mood disorders, anxiety disorders etc. Many studies have been done on cocaine addiction, which have shown very promising results across different countries around the world. The two widely used treatments are vigabatrin and placebo therapies.
The purpose of this study is also based on reducing cocaine dependence through psychological therapies of vigabatrin and placebo. These are psychological and medical treatments to decrease the use of cocaine drug in the patient. These include therapies, and use of the medical drugs to reduce the patients impulsive desire to use cocaine regularly.
The antiepileptic vigabatrin has shown promising results in the recent researches in the medical field of cocaine addictive patients. These researches are done on the basis of individual therapies as well as the supportive group therapies. The therapies are conducted on the patients who were using cocaine excessively.
Through this research study, the researchers tried to evaluate that the treatment of vigabatrin reduces the stimulant of drugs addiction, which consequently decreases the usage of cocaine in the patients. This article tells us that these treatments are based on weekly durations, which start from 3 to 9 weeks treatments in the cocaine addictive patients.
Design:
This article discusses that the method and design of vigabatrin treatment has a number of steps to treat a patient with cocaine dependence. The steps used in the study are mainly as follows, survey, hypothesis, sampling, study design, assessment, and treatment etc. Psychologists and psychiatrists design their research plan according to the study design phases; these are primary screening and secondary screening. Primary screening is the basic step of vigabatrin treatment in which patient’s bio chemical changes are tested through urine testing and past drug usage while secondary screening includes the physical examination of the patient. This research has been designed for the period of two weeks. These screenings have usual results which are head ache, drug craving, and mood depression in the patient’s attitude.
Setting:
The setting as discussed in this article for vigabatrin treatment is from urban to private dimensions and nongovernmental organizations in the city of Mexico; this setting was carried out on a population sample of 27 million in a 100-square-mile area. The clinic used in this research is located near the prison, that is, 12 miles from the parole office. The setting used in this research also included the inclusion and exclusion criteria to assess the participants that were selected.
Study population:
The study population for this research study was assessed in the city prison of Mexico. The patients who were recruited at the prison were mostly poor and unemployed. This study’s population was selected on the basis of patient’s excessive addiction over cocaine drug. Patients who screened were not told the results of the study’s eligibility criteria. Participants were screened over positive urine testing, chronicle alcohol usage and rate of increase in cocaine dependence. The study provided the inclusion and exclusion criteria in cocaine dependence patients. Inclusion criteria included the patients who were positive on urine testing and fell on the DSM IV cocaine addiction scale. Exclusion criteria included the patients who were addicted to other drugs other than nicotine, marijuana and cocaine. Patients are excluded on the criteria of excessive alcohol usage, detoxification, visual defectiveness, myopia, past history of crime, and neuron- chemical disorder etc.
Intervention:
The methods of intervention has explained in this article demonstrate that Vigabatrin works as a catalyst, which increases the production of GABA in the brain, this is how it works. GABA reduces the amount of dopamine which in turn decreases the chemical of cocaine and induces pleasure in the brain. The therapies were based on two basic criteria; individual therapy and therapies in group. Patients were tested with the amount of dose mixed with orange juice, consumption of juice resulted in reduction of cocaine usage in the patients. There was another technique developed by the psychiatrist Dr. Figueroa who examined patients with a questionnaire called DSM-IV diagnoses. Patients were rated on the rating scales for 1 to 13 weeks therapies process. These therapies resulted in the similar response in most of the patients like craving for drug, head ache, frequent mood swings etc.
Outcome measures:
The implementation of these two therapies on cocaine addicts resulted in measuring outcomes in terms of changes in their behavior and urine tests. After conducting these therapies for three weeks, results were obtained which showed that the same patients were negative in urine testing and they were not feeling impulse addiction towards the drug. All patients from the sample population were tested for 3 weeks and there were different results for all of them.
Some patients complained that they were suffering from extreme mood depressions, some from anxiety and some from neuron chemical changes in their body fluid. These changes also resulted in somatic abnormalities in the patients. There were also weekly outcomes obtained from this research study, which were tested between two groups. The groups were tested for vigabatrin and placebo treatments. There results were similar at the start of the treatment but gradually patients using vigabatrin treatment showed increase in drug reduction usage. Some patients were provided daily treatments over weeks that resulted in negative urine toxicology testing.
The treatment in patients was also developed on statistical data which showed comparison between the groups using vigabatrin treatment and placebo treatment. These two treatments were analyzed over weeks in the patients which resulted in the outcome measure over one group therapy to the other therapy. The different techniques used in vigabatrin and placebo treatments are mainly, significance level and power, full end-of-trial abstinence from cocaine and other substance use.
Results:
The results analyzed in both the treatments were different. Patients, who were given vigabatrin treatment, showed positive results as compared to the patients given the placebo treatment. The only positive factor in placebo treatment patients over vigabatrin treatment patients was that placebo patients were better in appetite. Positive results of Vigabatrin treatments were higher than the placebo treatment. In both the treatments patients were reported to be addicts of drugs like cocaine, marijuana, and alcohol. Vigabatrin treatment showed 46% results as compared to placebo treatment which was 30% in the overall treatments procedure.
Conclusion:
The treatment of vigabatrin therapy resulted in positive changes in the patients/drug addicts. Vigabatrin treatment was more efficient in patients than placebo treatment. Vigabatrin treatment which inhabits the increase of cocaine pleasure, increases the production of GABA in the brain, this is how it works. GABA reduces the amount of dopamine which in turn decreases the chemical of cocaine, which induces pleasure in the brain. This results in negative urine toxicology testing in patients and reduction in drug usage. These treatments are widely used in United Sates and outside United States as well. Patients were examined for several weeks in the therapy process. The common outcomes resulted in patients were mood swings, anxiety disorder and drug craving. There were no serious adverse case reported in the over all therapy process, some patients were also reported for hyper tensions and somatic nervous disorders.
Commentary:
Psychologists are using vigabatrin therapies to help patients overcome cocaine addiction problems. These therapies are most common in patients from 15 -40 age group, and are widely used today all over the world. Psychologists conduct theses therapies to reduce maladaptive behavior caused by the use by the cocaine and other drugs. Therapies were conducted on weekly, daily, and monthly basis which were mainly examined between two groups using vigabatrin treatment and placebo treatment. These therapies are widely used to overcome patients with drugs problems which include male or female patients. These are psychological and medical treatments to decrease the use of cocaine and sedative drugs in the patient. These include therapies, and use of the medical drugs to reduce the patients impulsive desire to use cocaine regularly. Female patients could not treat in the case of pregnancy positive test results. Patients treated with vigabatrin therapies were reported more positive result compared to other similar available therapies.
Background:
Cocaine is sedative drug which causes brain damage and nervous blockage. Many studies have been done on cocaine addiction, which are very promising these days across different countries of the world. The two widely used treatments are vigabatrin and placebo therapies. These are psychological and medical treatments to decrease the use of cocaine and sedative drugs in the patient. These include therapies, and use of the medical drugs to reduce the patients impulsive desire to use cocaine regularly. These therapies are conducted by psychologists in centers and clinics for several weeks, which examine the results caused by the therapy procedure.
References
Brodie J.D., Figueroa E., Laska E.M. And Dewey S.L. Safety and efficacy of gamma-vinyl GABA (GVG) for the treatment of methamphetamine and/or cocaine addiction. Synapse 2005; 55:122 — 125
Brodie J.D., Figueroa E. And Dewey S.L. Treating cocaine addiction: from preclinical to clinical trial experience with gamma-vinyl GABA. Synapse 2003; 50:261 — 265
Jonathan D. Brodie, Brady G. Case, Emilia Figueroa, Stephen L. Dewey, James a. Robinson, Joseph a. Wanderling, Eugene M. Laska. Randomized, Double-Blind, Placebo-Controlled Trial of Vigabatrin for the Treatment of Cocaine Dependence in Mexican Parolees
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