Which agency has issued guidelines for clinical studies involving alcohol-abusing participants?
Alcohol Clinical Trials Initiative (ACTIVE)The mission of the Alcohol Clinical Trials Initiative (ACTIVE) workgroup is to develop consensus reviews and recommendations to improve the design, execution, and interpretation of trials of medications for the treatment of alcohol dependence. It is not the intention of the group to propose standards that would be considered as requirements for the approval of product applications by regulatory agencies, but to advance the science of clinical trials in alcoholism treatment. Although the primary interest at this time is in studies of medications to treat alcohol dependence, the recommendations of this group may also apply to non-drug treatments. The processes that lead to consensus reviews and recommendations in this area might be applied to the development of consensus reviews and recommendations for trials to treat other drug dependencies. In addition, the ASCP leadership believes ACTIVE could be a "model" for other industry, academic and government agencies initiatives. The ACTIVE Workgroup is made up of two representatives from each of the supporting corporations, representatives from FDA, NIDA and a number of academic experts, as well as consultation with NIAAA on an ad hoc basis. ACTIVE also includes academic experts from Europe and exchanges information with the European Medications Agency (EMA) on an ad hoc basis. The twice a year meetings began in January 2009 and are ongoing. Show
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people who were not in the study but have the same characteristics as the study participants. Answer & Explanation Solved by verified expert a. Fusce du inia pulvinar tortor nec facil icitur laoreet. Nam risus ante, dapibus a molestie consequat, u , dictum vitae icitur laoreet. Nam risus ante, dapibus a mole trices ac magna. Fusce dui lectus, congue vel laoreet ac, dictum vitae odio. D Unlock full access to Course Hero Explore over 16 million step-by-step answers from our library Subscribe to view answer Step-by-step explanation a. Fusce
nec facilisis. Pellentesque dapibus efficitur laoreet. Nam risus ante, dapibus a molestie consequat, ultrices ac magna. Fusce dui lectus, congue vel laoreet ac, dictum vitae odi Student reviews 50% (4 ratings) Effects of an experimental drug on alcohol cravingStudy ID: 19-DA-N075The purpose of this study is to test whether an experimental drug affects the craving to consume alcohol. This study is accepting men and women who are 18–70 years of age, are in generally good health, drink alcohol, and are willing to stop drinking alcohol during the study. Participation includes inpatient stays, for approximately 21 days, at the National Institute on Drug Abuse’s overnight center in East Baltimore. For research purposes, participants will:
This study takes place at the NIDA Intramural Research Program located on the Johns Hopkins Bayview campus in east Baltimore. There is no cost for participation, and participants are paid for their time and travel. Do you have a few moments? If right now isn't convenient, Effects of a new behavioral intervention on alcohol craving and drinkingStudy ID: 16-DA-N140The purpose of this study is to see if we can use visual imagery and behavioral techniques to reduce alcohol craving and drinking in people who drink. This study is accepting men and women who are 21-65 years of age, are in generally good health, have consumed alcoholic beverages every week in the last 3 months and like the sight and smell of alcohol. Participation includes 6 study visits over 4 weeks lasting up to 4 hours each with the exception of the last study visit which lasts approximately 7.5 hours. For research purposes, participants will:
This study takes place at the NIDA Intramural Research Program located on the Johns Hopkins Bayview campus in east Baltimore. There is no cost for participation and participants are paid for their time and travel. Do you have a few moments? Ketogenic Diet in AlcoholismStudy ID: 17-AA-0152This research study is investigating if eating a ketogenic diet (including high fat, low carbohydrate shakes) will have an effect on symptoms of alcohol withdrawal and on brain function in patients with alcohol use disorder undergoing inpatient treatment of alcohol detoxification. Research participation includes participating in our inpatient alcohol treatment program at the NIH Clinical Center in Bethesda, Maryland. While in our program participants will be assigned to a meal plan for 3 or more weeks. The meal plan will consist of a ketogenic diet (high fat, low carbohydrates) or standard American diet. Activity level and sleep patterns will be monitored. Participants will also have a physical exam, medical history including alcohol and drug use, MRI scan, blood work, and urine analysis. The study is enrolling 18-75 year olds who are willing and able to provide written informed consent. You may be eligible if you have a moderate to severe alcohol disorder and are seeking treatment for your alcohol use. You do not need to pay to participate in this study. You will receive inpatient alcohol detoxification and treatment at no cost. You will be financially compensated for your participation. NIH will provide travel to and from the NIH Clinical Center within the United States. For more details, call NIH Clinical Center Office of Patient Recruitment at 1-800-411-1222 1-800-411-1222 What does the National Institute on Alcohol Abuse and Alcoholism do?NIAAA supports and conducts research on the impact of alcohol use on human health and well-being.
When was the National Institute on Alcohol Abuse and Alcoholism?The National Institute on Alcohol Abuse and Alcoholism was first established as a component of the National Institute of Mental Health (NIMH). It then became a separate institute alongside NIMH and the National Institute on Drug Abuse under the Alcohol, Drug Abuse, and Mental Health Administration in 1974.
How much alcohol is considered Alcohol Abuse?For men, consuming more than 4 drinks on any day or more than 14 drinks per week. For women, consuming more than 3 drinks on any day or more than 7 drinks per week.
How many drinks is considered binge drinking for a male?Binge drinking is defined as consuming 5 or more drinks on an occasion for men or 4 or more drinks on an occasion for women. Most people who binge drink do not have a severe alcohol use disorder.
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