Monash University Study

[Guest niall]

Hey guys, Monash University needs your help! Have you used cannabis, lsd, cocaine and other illicit drugs but NEVER used ecstasy? Then read on: (Edit: Kelly asked me for people who have used other drugs but not ecstasy - not what she's written below but trust me on this, I think she has plenty of ectsasy users and needs a control group of drug users who have never used ecstasy!):

 

 

REQUESTING MALES and FEMALES RESIDING IN MELBOURNE TO PARTICIPATE IN A BIOLOGICAL STUDY ABOUT THE EFFECTS OF ECSTASY AND OTHER DRUG USE

 

My name is Kelly Allott and I am conducting a research project as part of a Doctorate of Clinical Neuropsychology at Monash University, Melbourne. The aim of the project is to examine the effects of ecstasy and other drug use on aspects of brain functioning.

 

I am seeking English-speaking people who are currently resident in Melbourne and at least 18 years of age, who belong to one of the following groups:

 

1. Males and females who currently use ecstasy and have used ecstasy at least 50 times in their lifetime;

 

Males and females who use other drugs (such as cannabis, LSD, speed, cocaine) but have NEVER used ecstasy; and

 

Females who have NEVER used illegal drugs.

 

This project involves approximately 12 hours of participation and participants will be paid $100 at completion of the study.

 

If this research interests you, please email me at kelly.allott@med.monash.edu.au, and a full project explanation can be emailed to you.

 

 

 

 

 

 

 

PROJECT EXPLANATION

 

Project Title: Neuroendocrine functioning and subjective experience in regular users of ecstasy

 

My name is Kelly Allott and I am conducting a research project as part of a Doctorate of Clinical Neuropsychology at Monash University. My research is being conducted under the supervision of Associate Professor Jennifer Redman of The Centre for Applied Drug and Alcohol Research (CADAR), Monash University. Other researchers involved in the project are Dr. Jillian Broadbear, Associate Professor Ben Canny and Dr. Brendan Murphy.

 

Your Consent

You are invited to take part in this research project. This Project Explanation contains detailed information about the research project. Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this project before you decide whether or not to take part in it. Please read this Project Explanation carefully. Feel free to ask questions about any information in the explanation and feel free to discuss the project with a relative or friend.

 

Once you understand what the project is about and if you agree to take part in it, you will be asked to sign a Consent Form. By signing the Consent From you indicate that you understand the information and that you give your consent to participate in the research project. You will be given a copy of both the Consent Form and this Project Explanation to keep as a record.

 

What is the purpose of this study?

Research has shown that repeated ecstasy (MDMA) use might alter the chemical functioning of the brain. The purpose of this project is to investigate the brain functioning of current regular ecstasy users. The project also aims to explore whether there are gender differences regarding the brain functioning of regular ecstasy users. One common method for assessing the functioning of brain chemicals is via a medication challenge test, which involves measuring participants’ hormone response following the administration of a medication. Hormone response can be easily measured through blood samples. The degree to which particular hormones are released into the blood following administration of a medication can provide an index of the chemical functioning of the brain. If there were changes to the chemical system in the brain, then hormonal release following medication would be altered.

 

The purpose of this project is to compare the hormone response of people who currently use ecstasy and have used ecstasy more than 50 times, with people who use other drugs, but who do not use ecstasy, and with people who have never used illicit drugs. The project also aims to compare the response of males compared with females in each group, as little is known about gender differences in the effects of ecstasy use.

 

It is hoped that the findings from this project will provide important information for people working in the health professions and users of ecstasy and other drugs, to enable them to make the safest and informed decisions about their drug use.

 

Who is eligible to participate in this study?

I am seeking English-speaking people who are over 18 years of age who currently use ecstasy and have used it at least 50 times, as well as people who do not use ecstasy, but who use other drugs such as cocaine, speed, LSD or cannabis. I am also looking for people who have never used illicit drugs.

 

To ensure that safety is maximised for participants, certain individuals will be ineligible to participate in this study. A thorough screening interview will be conducted first by Kelly Allott and individuals will be excluded from participation if any of the following conditions are detected:

 

Current prescription of any medication (except for the oral contraceptive pill)

Body size that falls outside of a specified range

Previous or current major medical illness

Previous or current major mental disorder (except past history of depression or anxiety)

Previous or current physical substance dependence (except past cannabis dependence)

Pregnancy or breast feeding

Shift work

Females not taking an oral contraceptive pill. Any female recruited into the study must have been taking a monophasic (the same dose throughout 21 days) oral contraceptive pill for at least three months to ensure that menstrual cycle phase is controlled.

 

What will be required if I agree to participate?

If you agree to participate in this study, you will be required to complete three separate stages.

 

1. Screening: You will first be interviewed briefly over the phone in order to clarify if you are suitable for the research. This will take 5-10 minutes. You will then be required to undergo a face-to-face screening interview in order to assess the presence of any exclusion criteria. This will be conducted with Kelly Allott. She will assess for the presence of mental illness, medical illness, and substance dependence. This will take approximately one hour and can be conducted at a time convenient to you. Should any medical or psychological problem be detected during this interview it will be discussed with you and you will be given advice about how you can obtain further therapeutic assistance, which may involve referral to an appropriate practitioner.

 

2. Drug History and Self-Report Measures: If after screening, you are accepted into the study, you will undergo a one-hour interview aimed to gather descriptive and substance use information. Questions asked will include all licit and illicit substances you have used, age of first use, frequency of use, duration of use, usual dose and amount consumed in lifetime. Additionally, you will be questioned regarding the positive or desired effects from using ecstasy as well as any negative effects you may have experienced. This interview will occur at a place and time that is convenient to you. In addition, you will be asked to complete some short questionnaires relating to depression, hostility and impulsiveness – these may be sent to you in the mail if you prefer in order to reduce the time you are required to attend the study in person.

 

3. Medication Challenge: You will then be required to attend a laboratory at Monash University, Clayton campus, on two separate occasions in order to conduct two separate medication challenge tests (citalopram and placebo). This will occur on a weekday that is most convenient for you. Each challenge test will take approximately five hours and will be conducted at least two weeks apart. You will be asked not to use ecstasy or other illegal substances for one week prior to the procedure. On the night before each experiment you will be asked to go to bed before midnight to guarantee more than six hours sleep. You will be asked not to use alcoholic or caffeine-containing beverages the night before and on the day of the experiment. To ensure compliance with the requirement to be drug and alcohol free, you will undergo a Breathalyser test on the days of the experiment and if alcohol is detected the appointment will be rescheduled. Furthermore, blood taken during the procedure may be subject to screening at a later date for the presence of illegal substances. After carrying out your usual morning activities, you will be asked to arrive at the laboratory at 12noon. To control for menstrual cycle phase, all female participants must be on a monophasic oral contraceptive pill and will be tested during a time in their cycle when they are not menstruating.

 

 

You will not know which challenge substance will be administered to you on each of the two separate challenge tests. Placebo (sugar tablet) and citalopram will be administered to you orally in a random order on separate occasions. Citalopram is an antidepressant drug that has been chosen as the challenge medication because it binds well with the chemical system in the brain and is well tolerated by participants in previous challenge studies. 40mg of citalopram will be administered orally in tablet form and this is considered a medium dose. One of the researchers on our team who is trained in this procedure will conduct the blood sampling.

 

A needle will be inserted into your arm for blood sampling. A tube for sampling blood will be inserted. Two small blood samples will be taken approximately thirty minutes after you have settled in a comfortable reclined position. Immediately following the initial blood samples, 40mg of citalopram or placebo will be given to you to swallow. You will be asked not to look at the tablet so you are not aware which one you are taking. Eight further small blood samples will then be taken, each at 30-minute intervals. At each interval you will be asked to fill in a brief scale that measures how you are feeling.

 

During the medication challenge procedure you will be seated in a reclined position in a quiet, comfortable environment. You will be free to fill in questionnaires, sit quietly, watch television, read, listen to music or talk to the researchers at your leisure. If at any stage you feel uncomfortable or wish to discontinue, the blood taking procedure will be ceased immediately. You will be required to remain until any discomfort has subsided. Although extremely unlikely, if you remain negatively affected, medical assistance will be sought.

 

Total Time: The total time required of you to complete the study will be approximately 12 hours.

 

Participants will be paid $100 at completion of the study.

 

What are the potential risks and benefits of participation?

You may not receive direct clinical benefit from participating in this study. However, an indirect benefit is the opportunity to assist us in furthering our knowledge regarding the effects of ecstasy and other drug use, which may further the knowledge of health professionals and ecstasy users, and assist them in making informed decisions about their ecstasy and other drug use.

 

Participation in this study may cause some people to question whether they are happy with their drug use. A list of services is provided below that you may wish to contact for help or further information.

 

If you need help with any drug or alcohol problems or would like further information regarding drugs and alcohol, you can contact any of the following resources:

Direct Line (24/7 drug and alcohol help line) Ph: 1800 136 385 (Victoria only)

DRUGinfo (Australian Drug Foundation) Ph: 13 15 70 (Victoria) or (03) 2978 8100 (Australia wide)

Visit the Australian Drug Foundation website at www.adf.org.au

 

It is possible that you may experience some mild physical discomfort after consuming the single dose (40mg) of citalopram and during the blood taking procedure, but these are likely to be mild and short-lived. The most common side effects experienced after citalopram administration include nausea, diarrhoea, decreased appetite, dry mouth, perspiration, sleepiness and hand tremor. The incidence of each of these side effects compared to placebo is very low and if occur, relieve after a short while.

 

It is important for you to know that the use of drugs similar to citalopram (SSRI antidepressants) has recently been associated with an increase in the incidence of suicidal thoughts in some people. This increase appears to occur early in the use of the drug(s), and has mainly been reported in adolescents and children, rather than adults. There is no evidence that the increase occurs with a single use of citalopram (such as in this study), nor in users who have no evidence of disease or psychological disorders. We will phone you once each day for two days after the citalopram and placebo challenges, to check your recovery from the procedure. If any problem is detected, you will be referred to an appropriate service. You will also be given an information sheet with phone numbers you can call if you need assistance.

 

Protection of Privacy

The anonymity of your participation is maintained by our procedure, in which your name and contact information will be destroyed directly after your participation and consent forms will be kept separately to your data, which means that it will not be known which of the three groups you belong to. Only combined results of all participants will be published, therefore no published findings could identify any individual. Only my supervisor and I will have access to the data, which will be stored for at least five years as per university regulations. You should note that, while extremely unlikely, the data could not be withheld from police subpoena.

 

Participation is Voluntary

Your participation is voluntary, and you can choose not to participate in this study. If you do choose to participate and even after you have signed the consent form, you can decide to withdraw from the study at any time and any data collected from you will be destroyed.

 

Who can I speak to if I have any questions or concerns?

If you have any queries or concerns or would like to be informed of the overall research findings, please email Kelly Allott at kelly.allott@med.monash.edu.au or phone Associate Professor Jennifer Redman on 9905 3957 (Department of Psychology, Monash University).

 

 

You can complain about this research if you don’t like something about it. To complain about this research, you need to phone 9905 2052. You can then ask to speak to the secretary of the Human Ethics Committee and tell him or her that the number of the project is 2004/797. You could also write to the secretary. That person’s address is:

The Secretary

The Standing Committee on Ethics in Research Involving Humans

PO Box No 3A

Monash University Vic 3800

 

Telephone +61 3 9905 2052 Fax +61 3 9905 1420

Email: SCERH@adm.monash.edu.au

 

Thank you for considering participating in this project.

 

Kelly Allott

Edited June 26, 2006 by niall

[Stoney]

fuck me thats a long post ha ha ha

sorry mate count me out i've had it all

 

cheerz

[Budman2012]

Shrt post this one hehe

I bet Its cold in Melbourne, if I wanted to take ectasy It would be cheaper to buy it up here than the ticket to Melbourne. hehe

Bye now.

[Chev]

I'm outy too I'm in Perth anyway, only done an E 3 times in my life (didn't like em much) but I lurve acid Interesting study, I'm interested in the end results

[Stoney]

yeah would be really good to see the outcome of this research can you keep us posted niall thanks mate

 

cheerz

[pipeman]

I think its a crap study and I'm not interested in the results at all.