Also, if I'm not mixing info from several posts, I wonder what's behind the emphasis on the fly to France, if you're actually landing in Switzerland? Land at CDG, and surface to SW? G9 make it to final destination without refueling?
Thanks
Landing in France != CDG. Basel has two (or three?) exits to landside, one goes into France and one into Switzerland.
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I don't know anything about this particular study, but I work in research compliance so I am familiar with FDA regulations for clinical trials. Just to address some concerns addressed here, they have to say "up to $2500" because it sounds like they may screen you out after testing in New York. For example, if in New York they find that you have some medical condition that would make it unsafe for you to participate, you should be given some compensation for the testing in NY but not the full $2500. You must sign a consent form before they do anything to you; the consent form should specify the proration schedule.
Also, they are required to tell you that there may unforeseen adverse events. This is required by regulation. However, this drug is already FDA-approved for an indication other than jet lag. Therefore, it has already been extensively studied and the side effects well-documented. Again, the side effects should be specified in the consent form.
Bottom line - you have to sign a consent form before they do any testing. The consent form should answer any major questions you may have. If it doesn't then you shouldn't participate. It's unfortunate that you probably won't see the consent form until you get to NY. I wonder if you could ask that they send it to you beforehand?
I received my consent form and tons of details by e-mail last week and I haven't had my exam yet. I'm still on the fence about doing it. I really don't want to feel uncomfortable of like a guinea pig. I don't know if that's worth less than $2000 (I'll have to pay taxes and it will actually end up being a good bit less than that).
I would have some serious reservations about participating in this study.
Quote:
Originally Posted by jfkeze
there were about 50-60 people present at their offices, a mix of backgrounds, young people and quite a few middle-aged individuals. A few people looked like bums picked off the streets…
Regarding the study, they did not disclose the name or laboratory producing the drug.
They should be willing to tell you who produces the drug and what it is called so you can look up the information on what it is exactly and what adverse effects it has caused during the time that it has been used. If they are not willing to tell you that, why are they hiding that information?
In addition, the fact that some participants looked like "bums picked off the streets" sounds very suspicious, and suggests that the $2500 is more of an incentive than it should be. People should only do this, or any other drug study, for altruistic reasons to help science advance, not to earn money or to cure their own ailments.
Quote:
Originally Posted by GoBucks
However, this drug is already FDA-approved for an indication other than jet lag. Therefore, it has already been extensively studied and the side effects well-documented. Again, the side effects should be specified in the consent form.
Bottom line - you have to sign a consent form before they do any testing. The consent form should answer any major questions you may have. If it doesn't then you shouldn't participate.
The fact that the drug has been used for another purpose doesn't ensure by itself that it will be safe for this purpose. Also, what is the planned dosage? Advil is safe for most people, but in a very large dose can do nasty things to your stomach. Also, this sleep medication has been used for people with sleep disorders. The volunteers here don't have sleep problems, but jet-lag, so they may experience adverse reactions. When a healthy person takes a drug intended to help someone who is sick, they may have a very different response than the sick person would.
*Please* take a look again at what I wrote in my previous post, which I restate here below. I didn't see any responses to that post, and I hope that people are really thinking carefully about why and whether they should do this:
Quote:
Originally Posted by salut0
I would advise anyone considering this to rethink it. Companies testing drugs don't do it for the benefit of the person undergoing the test; they do it for their own profit. They state that the $2.5k is not intended as an inducement, but is anyone here actually thinking of doing this for altruistic reasons?
Note that their website states: "As with all medication, subjects may experience adverse events (AE's), which are untoward events associated with the drugs being tested. However, common AE's associated with an investigational medication may or may not be known at the time of the subject's participation in a clinical trial."
That means: you might get very sick from this procedure/test and they can't predict what might happen.
Make sure you know what this company proposes to do if that happens. Will they charge your insurers? Will they make you pay yourself for any treatment you need to counteract any adverse effects? What would your insurance company say if they were approached by you or this company seeking to claim costs for treating the adverse effects that you suffered, given that you entered this trial voluntarily to test an elective and non-essential drug?
Read this news report about a past drug trial gone bad and then think about it...
They DO tell you the name of the drug if you pass the initial screening. I have all of the info on it in the packet they sent me which they have me a week before my physical exam and I had all the time in the world to read it and ask questions. Also, I think a LOT of people try for the study but very few get through. They do drug and alcohol testing at every step in the study and do not allow either. When i did the phone screen, they told me the vast majority of people don't make it past that point.
The explanation they sent me is over 20 pages long and outlines everything about how they handle adverse reactions, how they get you back to the US is you become sick, etc.
...would a participant PLEASE supply drug name and expected side effects?
2nd request.
Thank you. I'm sitting here with my PDR, hoping for a reply, even PM, if not to FT.
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...would a participant PLEASE supply drug name and expected side effects?
2nd request.
Thank you. I'm sitting here with my PDR, hoping for a reply, even PM, if not to FT.
The drug is called armodafinil and it will be given in 50 and 150mg/day doses. One third of the participants will receive a placebo.
The drug is called armodafinil and it will be given in 50 and 150mg/day doses. One third of the participants will receive a placebo.
From Wikipedia: Armodafinil (Nuvigil) is a stimulant-like drug produced by the pharmaceutical company Cephalon Inc., which was approved by the FDA on June 15, 2007.[1]
Cephalon plans to conduct clinical trials evaluating the use of Nuvigil as a treatment for serious medical conditions such as bipolar depression, cognition associated with schizophrenia, and excessive sleepiness and fatigue in conditions such as Parkinson's disease and cancer.[2]
Nuvigil is protected by a U.S. patent expiring in 2023 that claims the Form 1 polymorph of armodafinil.
The drug is called armodafinil and it will be given in 50 and 150mg/day doses. One third of the participants will receive a placebo.
though I am not a medical professional I think what one reads here: http://www.rxlist.com/nuvigil-drug.htm
should be helpful when deciding whether and why to participate --or not.
I couldn'a dunnit withoutcha.
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I forwarded this to a friend who was looking to get a job during the winter break but some work on a show for Spring eats into it enouh to make getting a job for just 4 weeks looks ridiculous. He's a grad student relatively close to NY.
He's one of those people who enjoys flying (I personally enjoy the destinations, not the flights) and $2,500 for one week of work since he can't otherwise work is right up his alley.
Try to think of it from a data collecting perspective...
If they are studying the effects on you, there needs to be a controlled environment.
Flying someone to France and letting them go clubbing is not a controlled environment.
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I applied and somehow ended up in another study for a larger amount of cash. Although it requires me to be here 3 times for 48 hours. Well its my frist day and I'm bored. They claim to be frantically looking for more people to go to France. I hope after this to be able to do the France trip.
