The Food and Drug Administration (FDA) approved naltrexone in 1994 to assist in the treatment of alcohol dependence (Mark et. al, 2003). According to multiple studies of various sizes the medication has been proven to be highly beneficial in assisting with alcohol withdrawal and relapse (Leavitt, 2002; Rohsenow, 2004; Williams, 2005). With the approval of the FDA and the backing of many studies, why is this wonder drug not being more widely used? The following will address how naltrexone works and how it compares to other medications used in the treatment of alcohol dependence. Also included is the reasoning behind the professional hesitance in prescribing naltrexone.
The Beginning and its Workings Naltrexone was the first medication in fifty years to be approved and marketed for the purpose of treating alcohol dependence (Mark et. al, 2003). Most commonly known as ReVia, the medication is recommended for use in conjunction with psychosocial therapy (KAP, 2010; Leavitt, 2002). The original purpose of naltrexone was for the treatment of opioid addictions such as morphine or other opiate drugs. Eventually, its benefits to those who are alcohol dependent became apparent. The medication works for alcohol dependence as it does for opiate addiction. As an opioid antagonist, naltrexone removes the reward or the ‘high’ when alcohol is consumed by blocking the opioids in the brain (Substance Abuse, 2012). By blocking the endogenous opioids in the brain, the medication has
With the possibility of drugs capable of suppressing the urge to consume alcohol in addicts, many people who normally would not be helped by a simple 12 step program, could use such drugs in combination with standard treatment in the future to help combat their addiction.
This analysis has a special interest in the use of buprenorphine/naloxone and methadone in the treatment of opioid addiction. More research is being conducted as to
Food and drug administration is a department of U.S health and human services. It’s responsibility is to test the safety and efficacy of new drugs entering the market as well as to make sure that these medicines are quickly accessible to people. The Food, Drug, and Cosmetic Act has been passed in 1938 to ensure that foods other than meat, poultry and fish are clinically hygienic and safe to eat. This act also requires that the food should be labelled according to its content. (FDA.org) Drugs and tobacco are also regulated by FDA and in 1996, FDA strictly regulated the use of tobacco products like nicotine, cigarettes and smokeless tobacco, by children and adolescents because of the increase in diseases prevalence and tobacco addiction. Annually 40000 deaths are attributable to its use and most of them are of premature. Therefore the goal of FDA is to stop the tobacco addiction by minors and prevent the deaths and diseases due to nicotine addiction. (FDA vs Brown, n.d) This essay will cover the food and drug administration’s role in under and over regulating drugs and medicines and how it effects our economy, health care system and patients health and safety.
Alcoholism is a long standing health issue, and there has been ongoing research to seek out drugs that could effectively help to treat alcoholism, acute and long-term. According to an article by Johnson, Swift, Addolorato, Ciraulo, and Myrick (2005), a challenge has been to identify medications that not only reduce the rewarding effects of alcohol, but the dependence, post cessation craving, and the withdrawal craving.
Proponents of harm reduction argue that instead of penalizing individuals for partaking in illicit drug use, it is more productive to create policies and procedures that reduce the likelihood of harmful consequences of such drug use (14). Naloxone, an opioid antagonist and overdose reversal medication, has been shown to be a highly effective harm reduction strategy. If used quickly, naloxone can prevent and overdose and reverse the effects of opioids (15). Previously only used by EMT’s and other medical professionals, allowing laypersons to access and use naloxone has successfully prevented opioid-related overdoses (13, 16-18). While naloxone is the most studied and validated harm reduction method, others have been employed nationally. Though not validated through peer-reviewed literature, Project Lazarus and the Harm Reduction Coalition, two harm-reduction centered non-profits, advocate that when using drugs, people should use together, and avoid mixing drugs as a means of reducing the likelihood of overdose (19-22). Many fatal-overdoses result from poly-substance drug use and therefore, the recommendation of avoiding poly-substance use bares significance even if this harm reduction strategy has not been analyses in a scientific context
However, it can only be prescribed when the patient is fully clean of opioid use, in which it can then be used and help prevent relapse. Lastly, Naloxone is used to “prevent death due to opioid overdose” (Leahy), which is imperative in the middle of the opioid epidemic. Having an MAT that can give patients another chance at life and recovery is beneficial in resisting the endemic (Leahy). While participating in these forms of treatment is proven to be beneficial, it is also important to consider counseling and behavioral therapists, which can help alert patients overcome their feelings and emotions towards opioids and the high they
Many studies involving XR-NTX treatment require participants to remain abstinent prior to treatment or they are excluded from participation. In terms of improving outpatient treatment with XR-NTX, Mannelli, et al. (2014) attempted to address the issue of patients being able to maintain an abstinent state prior to receiving XR-NTX. The results of the pilot study suggest that gradually increasing low doses of naltrexone while gradually decreasing low doses of Suboxone can successfully transition patients to XR-NTX administration. Because this was a pilot study, it is recommended thata double-blind, placebo-controlled study be conducted with a larger sample size. The importance of being able to mitigate the difficulty some patients may face obtaining a prolong abstinent-state is crucial if XR-NTX is to take a leading role in OUD pharmacotherapy. These finding could be particularly important for patients that have limited or no access to
In 2000, the US Food and Drug Administration issued a health claim which states that consuming foods containing plant sterol and stanol esters along with other low cholesterol and saturated fat foods can reduce the risk of coronary heart disease (Jones, Vanstone, Raeini-Sarjaz, & St-Onge, 2003). Today, many functional foods in the form of margarines, spread, yogurt, and others, have been enriched with phytosterols and advocated as being able to reduce the risk of coronary heart disease. Phytosterols have been known for its cholesterol-lowering effect by blocking absorption of cholesterol in the intestines. However, there are controversies surrounding the efficacy of phytosetrol that are enriched in foods in reducing cholesterol levels. Many studies have also demonstrated the efficacy of phytosterol-enriched foods. Vásquez-Trespalacios and Romero-Palacio (2014) and Amundsen, Ose, Nenseter, and Ntanios (2002) have demonstrated the efficacy of phytosterol-enriched foods in reducing total and LDL-cholesterol levels. However, there are also many studies that show otherwise. For example, Jones et al. (2003) and Weingärtner et al. (2016) have shown that phytosterol-supplemented foods did not have any effect on total and LDL-cholesterol levels. The debate regarding the efficacy of phytosterol in functional foods is crucial as phytosterol-enriched foods can potentially be a solution to a continuous increase in population suffering from cardiovascular diseases. The
Everyday more and more treatment options and medications are being used to help to combat the world of drug abuse and addiction. According to the CDC about 980,000 people in the United States are abusing some form of opiates, weather it is pills or heroin. One of the newer trends of treatment that is now being used and growing rapidly is Medical Assisted Treatment (MEDICAL ASSISTED TREATMENT). As with any treatment or medication therapy there are the medical benefits and also the medical downsides. Medical Assisted Treatment was intended to help prevent people from continuing their drug abuse, but is now not only helping people but is also turning into an abused drug itself. ‘
In a recent open-label pilot study by Mannelli, et al. (2014), it was examined whether or not patients can be safely and effectively administered XR-NTX after using opioids by using oral naltrexone and buprenorphine to mediate the transition. The 20 participants included in the study were administered naltrexone (days 1–7), buprenorphine (days 1–3), and a single 380mg injection of XR-NTX (day 8), with scheduled assessment visits on days 1-9 and then weekly through week 4. Fifteen of 20 participants successfully concluded the induction phase (day 7), and 14 received XR-NTX (day 8). Opioid withdrawal and narcotic craving from day 1 of the study were measured using the Subjective Opiate Withdrawal Scale (SOWS), Clinical Opiate Withdrawal
When it comes substance abuse treatment many old school clinicians believe in the model of abstinence, however, many of the newer clinicians believe and full support the idea of harm reduction. Even though both sides have their supporters, and a full body of literature to support their argument that one is better than the other, however, harm reduction has been shown to be the most effective, and the one that clients prefer over abstinence, especially, when the client is starting treatment. Harm reduction is when the client reduces drug and/or alcohol intake for a short period of time, while abstinence is when the client stops taking drugs and/or alcohol immediately and tries to stay away from it.
Some addiction psychiatrists have cautioned against the rising excitement concerning Vivitrol. “Naltrexone buys you a month, but if you stop taking it and you haven’t developed coping strategies you may relapse,” said H. Westley Clark, a retired former director in the Substance Abuse and Mental Health Services Administration. “People do recover from opioid dependencies, but often to do so they also need to deal with other issues in their lives” (Tabachnick, n.d).
There is a catch to it though. The person has to be consuming alcohol at the same time as taking the naltrexone, or it will not work for that person. That is because alcohol consumption causes the body to release regularly occurring opioids. Naltrexone must bind to an opioid in order to make its way into the brain, and in time it blocks the opioids from attaching to the brain’s receptors. In other words, you have to remain consuming alcohol in order for naltrexone to show your body to stop desiring the alcohol. This has shown to be more effective than a 12 step
In this essay, the effectiveness of the pharmacological treatments for opiates, nicotine, cocaine, and alcohol in relation to addiction relief and prevention will be critically evaluated. This will be accomplished through an investigation of the respective substances and their current treatment’s methods and levels of success, such as the use of Substitution Therapy, agonist and antagonist treatments, and preventative drugs. Furthermore, the generation of directions for future research and treatments will be performed, particularly assessing the potentiality for remedying addiction through substance-tailored vaccinations and suggestions for solidifying a scientifically accepted methodology for the treatment of cocaine dependency.
Physicians have several options for treating alcohol use disorders. Behavioral therapy can help alcoholics recognize and avoid high-risk situations, and referral to programs that provide peer support, such as Alcoholics Anonymous, can increase a person’s chance of recovery. Therapists can also prescribe medications that decrease the appeal of alcohol. Studies show disulfiram, acamprosate and naltrexone help most people abstain from alcohol. Disulfiram causes unpleasant side effects such as sweating, nausea, headache, vomiting and chest pain when patients consume alcohol. The severity of the effects differs among patients, and is correlated with the amount of alcohol consumed. Naltrexone inhibits euphoric effects or feelings of intoxication