Opioid dependence on drugs, both banned and prescription drugs is an increasing problem that requires the development of the most effective drug therapy (MAT) and the study of the results of proposed therapies for understanding the treatment of opioid dependence in the future. Thus, 2.4 million Americans are stricken from opioid dependence, which makes the study of the results of existing therapy meaningful (Itzoe & Guarnieri, 2017). The definition of effective treatment of opioid dependence is necessary to reduce the mortality, crime and illicit use of opioids in the population, which makes the study of results among patients extremely important ("Patient Management", 2014). Recent decades have allowed the development of drug therapy based on the use of both oral and injectable drugs, for example, opioid agonists such as buprenorphine, oxycodone or methadone and antagonists such as naloxone, often using a combination of buprenorphine (Suboxone) and naloxone (Itzoe & Guarnieri, 2017). The results of treatment with Suboxone and Naloxone are the goal of this study aimed at reviewing the condition of patients taking these drugs and assessing their sobriety, overall health, and the level of crime. This research is important, since, medical treatment often involves limitations and problems that can increase the risk of abuse. Clinical studies show that naltrexone (Vivitrol) indicates the average level of efficiency of treatment of dependence, however, in combination with other drugs, it increases the therapeutic index; nevertheless, naltrexone does not preclude the development depending on the antagonist (Itzoe & Guarnieri, 2017). Some studies point to concerns about opioid dependence, emphasizing the risk of overdose, criminality, injuries, and others (Benéitez and Gil-Alegre, 2017). As well, serious bodily injury, consisting of viral infections, liver cirrhosis, heart problems, as well as mental disorders, present in opioid dependence (Degenhardt & Hall 2012). In this regard, the study of the results of drug treatment is the most important goal for reducing such risks among the population and creating the most optimal treatment method with the use of the most effective drugs.
The analysis and comparison of the literature sources discussed in my study allow one to understand the problem of opioid dependence and to study the most advanced methods of treatment. Opioid dependence creates a physical dependence on the availability of medicines, leading to the fact that dependent patients, refusing treatment, are forced to take drugs themselves, thus increasing the level of social risk (Benéitez and Gil-Alegre, 2017). Therefore, among the treatment methods, one can single out the use of methadone, naltrexone, and buprenorphine for long-term treatment (Bart, 2012). Given that studies emphasize that such drugs as naltrexone and buprenorphine remain prioritized because of their ease of oral administration and the relationship between positive outcome and possible risks (Itzoe & Guarnieri, 2017). Naltrexone is considered as a drug that helps to successfully fight relapse, which explains its widespread use in the treatment of opioid-dependent ones and thus requires studying the evidence of its effectiveness and avoiding negative outcomes (Waller, 2014). However, Benéitez and Gil-Alegre emphasize that no combination of these drugs makes it possible to speak of full efficacy and, thus, the study of the results among patients using these medications can help to see which medication treatment allows achieving the best efficacy (2017). This can help in creating a future Medication Assisted Treatment (MAT), which includes the most effective drugs and their combination of new drugs.
Given that the US Food and Drug Administration approved buprenorphine in 2002 as an effective treatment, and the combination of buprenorphine and naloxone, called suboxone, is the most popular preoral treatment for opioid dependence, examining the results of treatment by monitoring and interviewing patients who undergo this treatment, can help in obtaining statistics that reflect the real results of this treatment (Mintzer et al., 2017). Bart argues that buprenorphine has low levels of side effects and promotes the removal of opiates from the body, while naltrexone (known as Vivitrol) helps to get rid of thoughts about the consumption of opioids and prevents cravings for future use (Bart, 2012). According to Gustafson et al, existing treatments for opioid dependence are often ineffective and can cause a relapse within a few months after completion of therapy (Gustafson et al., 2016). Thus, one may suggest that even the most popular therapies, including preoral drugs such as naltrexone and suboxone, can give different results depending on the environmental characteristics, the duration of the patient's dependence, the difference between the dependence in men and women, and also the level of motivation patient (Gustafson et al., 2016). Thus, consideration of the results of treatment with these drugs among patients belonging to different groups and having varying degrees of dependence and motivation may allow one to obtain average results of drug treatment of dependence and to evaluate the effectiveness of these drugs. Thus, the analysis of the literature confirms that medical treatment (MAT) using a combination of buprenorphine and naltrexone as well as suboxone is the simplest and most effective way to combat opioid dependence, but it also has some side effects, which means that it requires practical consideration of the results of treatment among patients.
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Participants in the study will be selected from patients in the MAT programs in San Diego County who will agree to allow me to provide a survey to the participants. Among the interviewed patients will be people with a past or present opioid dependence who received treatment suboxone and/or naltrexone (Vivitrol). All participants in the survey will be of age, however, they should all be MAT patients for a long time, so that it is possible to assess the level of effectiveness and treatment with drugs, while patients who have just begun treatment cannot be suitable for this purpose. In addition, conducting a study and obtaining reliable results requires a survey among 20 participants who have been treated for a long time, as well as 20 participants who have already undergone MAT with suboxone and/or naltrexone (Vivitrol), to understand the long-term effect of treatment.
Apparatus/ Materials and/ or Instruments
Firstly, I need paper and pencils for the survey. The survey will consist of two tests aimed at revealing the results of the treatment for those who have already passed the MAT, as well as those who are the active participants in the treatment program, but enough time to get certain results and draw conclusions about the effectiveness of treatment. In addition, the patient's informed consent form and the debriefing form of the study are necessary for the study.
The procedure for the study includes the selection of 40 test subjects, half of whom are on opioid dependence treatment, and the other half is the patients, who have already been treated. Further, I would create tests that include the basic indicators of the patient's health and dependency, including his level of dependence, sobriety, possible relapse, drug abuse, involvement in a crime, and so on. These tests would be common among the questioned parts of their two groups. Further, the results of surveys should be worked out by a statistical method and the main results of the polls of the two groups are identified. After this, I would use a comparison of the results of the two groups to obtain an average evaluation of the effectiveness of MAT, including the treatment of suboxone and/or naltrexone (Vivitrol). Such data could allow conclusions about the results of the treatment in question to be compared to past and present patients and compare the results with the data of the studies considered in the work to assess treatment and possible requirements for treatment of opioid dependence in future.
Considering that the survey includes testing of two independent groups of MAT patients, the design of the study is a mixed experimental design analysis and allows obtaining the most technical results for obtaining statistics on two different group tests, which makes it possible to compare the results obtained and independently evaluate each survey separately.
To carry out the survey analysis, the ANOVA statistics will be used to process the data in two groups. The mixed design of ANOVA is a matrix with levels of rows and columns between subject-factors (Gravetter and Forzano, 2018). This will allow studying the interaction of two effects between groups of subjects. The degree of freedom of assessment, reflecting the number of pieces of research information, reflects the total number of sampling units (n) -1 (Gravetter and Forzano, 2018). Thus, the degree of freedom of evaluation will be 40-1 = 39. At the same time, the alpha level, which reflects the probability of an incorrect decision, will be equal to 05 (Gravetter and Forzano, 2018). Therefore, this will allow determining the critical value, which determines the probable and unlikely, comparing the results of statistics with the value of a misfire. If, as a result of this, the statistic result becomes more extreme than the critical value, then the null hypothesis, determined by the alpha level, can be rejected.
The conducted study follows APA ethical guidelines, as it includes an informed consent form, debriefing statement, deception, and receipt of IRB permission. Therefore, given that the deception to improve benefits and minimize adverse effects is acceptable, but should be used with caution for the sake of ethical preservation, this study will not include deception, since there is no need. With regard to the informed consent of the patient, the form below will be used to comply with the ethical standards of the study.
Consent Form to Participate in Research
INTRODUCTION: This form of consent describes the procedures and explains the rights of study participants, as well as research objectives and benefits. If the participant agrees with the information listed above, he has the right to sign a copy of this form.
PURPOSE: The aim of this study is to obtain statistical data reflecting the state of health of patients with past or present opioid dependence, undergoing or undergoing suboxone and/or naltrexone (Vivitrol) treatment by questioning for analysis of the findings and evaluation of MAT, and for further development of effective drug treatments.
DURATION AND LOCATION OF STUDY: If a participant agrees to participate in the study, it will take one poll for an hour at a San Diego County medical facility.
PROCEDURES: During this study, a participant understands that he or she will be asked to provide answers to questions that the test contains.
POTENTIAL RISKS AND DISCOMFORTS: Since the study includes testing, there are no risks for the participant associated with his or her passage of the study.
BENEFITS: The passage of this study will allow participants to get an assessment of their own level of opioid dependence and health status and get recommendations for replacing the method of drug treatment if the study shows that it is necessary.
CONFIDENTIALITY: By agreeing to the testing, the participant understands that the received data will be kept confidential, as each participant will receive the code number instead of the name. In addition, one year after the research, all information received during the study will be destroyed.
COMPENSATION FOR PARTICIPATION: The participant receives a second medical consultation to improve his or her condition.
RIGHT TO REFUSE OR WITHDRAW/ OFFER TO ANSWER QUESTIONS: The participant understands that his participation in the testing is voluntary and he can refuse to participate at any time. In addition, a participant can ask any questions about his or her participation in the study, from the researcher via e-mail.
Confirmation of the participant that he or she is of legal age, a signature of the participant and date.
Moreover, a written legal form will be included in the conduct of the study and will look in the following way:
WRITTEN DEBRIEFING FORM
We thank all participants for the testing and provide more detailed data to understand the importance of this study and its purpose. Thus, this study is aimed at evaluating the MAT, including the use of suboxone and/or naltrexone (Vivitrol) and understanding the positive and negative effects to collect information that will improve treatment. We remind you that, since the research is voluntary, you can leave it, and the results of your testing will be destroyed. However, you should consider that depending on the results, testing can be repeated again after some time. In this regard, we ask you not to discuss your answers with each other to preserve the purity of the experiment; otherwise, the results of the study may be inaccurate. In addition, we remind you that the contact information is on your consent form and you can ask any questions about testing and your participation.
IRB permission will be obtained by writing a request for a study in a San Diego medical institution specializing in the treatment of opioid dependence, which will reflect the study's objectives, as well as the conditions for conducting the study.
The study may face some limitations, such as an inadequate sample for obtaining preterm results, no random sampling since all participants will be passed or current patients of the institution. Moreover, some restrictions may be the participation of patients belonging to a different status, gender and age, which may make the results common.
Thus, a study aimed at evaluating MAT using suboxone and / or naltrexone (Vivitrol) can provide a more accurate understanding of the results of treatment of opioids dependent on these drugs both during treatment and after treatment, which, depending on the results obtained, will allow future studies either develop this MAT, or modify it to achieve the greatest effectiveness in treatment.