Thoughts from a Lab Rat

I think I’ve touched on this topic a few times but I’m too lazy to research the last time. As if it’s that difficult to look it up. Anyhow, I’ve got a few people asking about it.
What is a washout?
It’s a period of time where one does not do something. In this case, it’s a period of time where you don’t do another clinical research study. Each clinic operates in a slightly different manner but for the most part, you must wait a minimum of 30 days between investigational drug studies. More specifically, it depends on the type of study you have done and the next study you plan on doing. Most drugs carry a 30 day washout. Certain studies such as radiolabel studies carry a one year washout before you can do another radiolabel study but usually a 30 day washout for a non-radiolabel study.
When does the washout period begin?
Well, each clinic and sponsor will decide. There are two possible scenarios. It may go based on the last dosing of the drug or it may go based on the last participation date of the study which means out-patient and or phone call. Again, this depends on the clinic and or sponsor of the next study you participate in.
Who is responsible for enforcing washouts?
Why that would be you! I recommend keeping a log of the studies you participate in, the dates and the drugs involved. It’s good information to have in order to make sure you don’t violate the washout rules and to make sure you don’t do the same study twice. Most sponsors do not allow participants to do the same study drug more than once. While they will eventually figure it out, it’s better to avoid it all together when you are researching studies to participate in.

It all starts with the first study. First of all, doing studies is not for everyone. Obviously, people who are squeamish about needles probably should stay away. My biggest recommendation is that you find a short study, less than a week so you can test the waters. By doing a short study, you will be able to see how the process works, how it feels to have 10 to 20 blood draws in a day and how it feels to be secluded from society. If you find that you don’t like how things are going, I do recommend at least finishing the study. A lot of hard work goes into putting a study on and while yes, you do have the right to quit a study at anytime, for any reason, once you have started taking the study drug, the safest thing to do is to finish out the study. If you do ask to be dropped from a study early, the study doctor will typically ask you to stay for at least one night to make sure that the study drugs are not having any adverse side-effects. Again, this is for your safety.

So, what should you expect during your first study? A lot of what happens during the study takes place at the screening. You will usually have ECG’s, vital signs, blood draws and examinations by the study doctor. Depending on the study, there may be additional procedures such has heart monitors, urine collection and position restrictions. All of the study procedures are outlined in the informed consent. Chat with some other people at the screening. Chances are, many of the other people there have done a study or two and can share some of their experiences. It’s usually not as bad as many people think it is. Most people who think being a research subject is dangerous or freaky probably have never done a study before. Of course, the media and film portrayals don’t help. Sure, things do happen but as long as you are truthful while enrolling in a study, you will minimize most risks.

I received this question anonymously from a fellow lab rat.

Q. What’s the big deal with grapefruit juice?

A. Nearly every study has a grapefruit product restriction. Why? Because it can interact with numerous medications and can be fatal.

Grapefruit juice, and grapefruit in general, is a potent inhibitor of the intestinal cytochrome P450 enzyme CYP3A4, which can impact the metabolism of a variety of drugs, increasing their bioavailability when administered orally. In some cases, this can lead to a fatal interaction with drugs like astemizole or terfenadine. The effect of grapefruit juice with regard to drug absorption was originally discovered in 1989. However, the effect became well-publicized after being responsible for a number of deaths due to overdosing on medication. However, the first published report on grapefruit drug interactions was in 1991 in the Lancet (British) entitled “Interactions of Citrus Juices with Felodipine and Nifedipine.” and was the first reported food-drug interaction clinically. (wikipedia)

There are many urban legends that have led people to believe that grapefruit juice is the “cleanse all” miracle cure. Smoke a joint before a drug test and swig a few glasses of grapefruit juice and you’ll piss cleaner than the day you were born. While I’m not here to confirm or deny whether or not that works, let’s just say it doesn’t. Sadly, it can have devastating consequences. Long story short, grapefruit juice prevents drugs from metabolizing correctly which means that the medication stays in the body longer than intended. In multiple doses, the medication will stockpile in the liver and can eventually lead to a drug overdose. Certainly there are many factors but in the end, clinics must eliminate as many factors that can effect a trial as possible. This is one major factor that you do not want to ignore.

Email me at reply@jalr.org if you have any questions you’d like answered and I may post them!

Was without my laptop for a few weeks so I haven’t had a chance to update the site. I’ll get to it next week. I have been told by multiple sources that Cedra in Austin has shut down and shifted all clinic operations to its San Antonio location. There is not any confirmation on the website and I keep forgetting to ask when I call for studies. Also, AAIPharma has apparently shuttered its clinic operations but the parent company still exists, so who knows what the future of the company will be. There are a few other minor changes.

Well, it looks like I was able to successfully restore the database. Horray!

All prices have been lowered! Just Another Lab Rat! recieves $1.96 from each sale which goes towards web hosting and other fees associated with running a website. Buy one today!
http://www.cafepress.com/drugspay

http://www.clinicaltrials.gov
This is a great website that few people know about or use. While the information on this site covers every trial in the US, it is raw data and does not include information like study dates and compensation amounts. The site is a great resource for finding out information about a particular study you may have called about before going into a screening. There are several ways to search but I find the easiest way to search is to hit the “search for clinical trials” link and in the search box, type in the basic name of the clinic and the city. Example, PPD Austin or Cedra San Antonio. You will get a list of recent studies at the clinic which are currently recruiting, not yet recruiting, completed and so on. The basic study protocol information is available as well as the study locations, expected enrollment, inclusions, exclusions and more. Again, this site should be used for gathering information rather than a method locating actual enrolling studies. This is only a database and the actual recruiting is done by the clinic hosting the study.

Repeats are routine but what are they and how do they work? Well, a repeat is called by the study doctor when a lab value, ECG, blood-pressure or other screening factor is outside of the protocol range. Each study has a range that every lab result must be within. Depending on how out of range the result is will determine whether a repeat will be allowed. Typically, things like blood pressure, body temperature and pulse rate will have an automatic repeat and depending on the study, may allow a manual repeat by a paramedic. Values related to drugs, cotinine and alcohol are not repeated and typically will result in automatic disqualification. For street drugs and sometimes alcohol, you may be banned from the clinic permanently. For most urine and blood values, if your results are slightly out of range, you will typically be called in for a repeat. If the study doctor feels that your results are “clinically significant” or abnormally out of range, you may not get a repeat and will be disqualified from the study. Sometimes the study doctor will refer you to your own physician for a follow-up before you are allowed to screen again.
A repeat can happen at any stage of the study. You can have a repeat from your screening, check-in, anytime during the study, your exit labs and or any outpatient visits. It is important to note that if you have a repeat for your screening, you are not considered screened until you complete the repeat. If you are finishing a study and have a repeat, you are not considered finished with the study until you complete the repeat. Any delays in doing a repeat can affect your inclusion into a study and your payment after a study. If you are asked for a repeat, you should try to get it done as fast as possible.
The reason repeats are done is to ensure your safety before, during and after a study. The study doctor wants to make sure that your screening labs are all within normal or sponsor required ranges to see if there are any changes once you start dosing in the study. Comparisons are done throughout the study to detect any problems. It’s best to think of repeats as being “better safe than sorry”.

The time between studies can be from 30 days which is ideal to months or longer. The standard washout for most stuides is 30 days while some may have longer washouts like radiolabel drugs which are one year before you can do another radiolabel drug. Most studies count the time since your last dose in a study while other count the last participation date which would normally be an out patient visit. Once you complete a study, you should be on the look out for your next study. Keep in mind that just because you schedule a study doesn’t mean you’ll get into the study. Studies get cancelled, postponed, reworked which may lead to exclusion or things may come up in your own life that prevent you from doing a study. It is important to realize that the money you make from one study may need to last for 6 to 8 weeks or longer as some clinics pay upon the conclusion of the study. If you’re like me, bad with money, you should always be on top of priorities like rent and phone bills. Like I always say, one day you’re scheduled to check into a 5k study and the next day you’re standing in line at Long John Silvers for a free fish taco. Don’t count your chickens until all of the eggs have hatched. Don’t write checks your body can’t cash. Keep on top of things and plan for dry spells. I’m, bad about things like that but that’s life. Peace yo’