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.
Current Supporters:
- Alkermes
- Dicerna
- Ethypharm
- Otsuka
Past Supporters:
- Abbott
- Amygdala Neurosciences, Inc.
- Arbor Pharmaceuticals
- Eli Lilly & Company
- GlaxoSmithKline
- Indivior
- Janssen
- Lundbeck
- Mitsubishi Tanabe Pharma
- Pfizer
- Schering Plough
people who were not in the study but have the same characteristics as the study participants.
A. TRUE
B. FALSE
2The IRB reviews and approves incentives for participation for which of the following?
A. Popularity.
B. Donor source.
C. Monetary value and form.
D. Creativity.
3Which agency has issued guidelines for clinical studies involving alcohol-abusing participants?
A. National Advisory
Council on Alcohol Abuse and Alcoholism
B. Research Board for Substance Abuse
C. Scientific Advisory Board for Alcohol and Substance Use Dependence
D. Research Council for Substance Use and Alcohol Addiction
4In order for a clinical investigation of a research question to occur, research sites must fulfill which of the following goals?
A. Improve an investigator's prominence in a field of study.
B. Increase the popularity of a research site.
C. Recruit an adequate number of
appropriate participants.
D. Retain study participation numbers for the time period specified in the research protocol.
E. A and C
F. C and D
5Study teams may use incentives for study participation; however, careful consideration should be given to avoid ___________.
A. Inducement
B. Rewards
C. Coercion
D. Free medical care
E. A and C
F. B and D
Answer & Explanation
Solved by verified expert
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Effects of an experimental drug on alcohol craving
Study 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:
- Take the study drug or placebo by mouth twice a day for half of the study and then switch and take the other one for the second half
- Taste several sweet solutions
- Have physical exams performed and vital signs taken
- Be exposed to alcohol, water, and food cues in a room that looks like a bar
- Answer questions on a computer
- Participate in virtual reality tasks
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.
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Effects of a new behavioral intervention on alcohol craving and drinking
Study 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:
- Complete questionnaires about your mood and behavior, including alcohol craving and drinking
- Answer questions on a custom-designed app using a study-issued smartphone
- Receive a physical exam
- Provide blood, urine samples
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.
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Ketogenic Diet in Alcoholism
Study 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