Pharmaceuticals in complex problem solving (The PECO Project)

Recruitment paused for the Holidays! Please check back in January 2018!

Pharmaceutical enhancement of complex optimisation (PECO) (HREC 1749142.1)

Introduction

This project will investigate how certain brain chemicals affect the ways in which people solve complex problems. The medications used in this study are prescribed in Australia for conditions like Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy, however they are also sometimes used by healthy people to help them study or improve their attention or memory. Previous studies have shown that these medications only sometimes have an effect on memory and attention, and very little research has been done on their effects on complex decision making. This project has been approved by The University of Melbourne’s Human Research Ethics Committee, and internally funded by The University of Melbourne.

What I will be asked to do?

Participants will need to come to five sessions, including a 30-minute-long preliminary session and four experimental sessions (at least one week apart). Each of the experimental sessions will last about three hours in total. All testing will be performed in the Clinical Trials Unit at the Murdoch Children’s Research Institute, Melbourne. The initial screening session will be held in November or December 2017, and the four testing sessions will be held in early 2018. Participants need to be aged between 18 and 35 years old.
Preliminary session: In the preliminary session, the researcher will explain the study and the tasks to you, and you will read about the medications that you are to receive. In order to assess your eligibility to participate in the study, and to ensure your safety and
comfort, you will be asked to answer a short questionnaire regarding medical history, family history, any current medications you might be taking (including prescription, over the counter, herbal or natural medications), any food allergies you may have, current weight, and (for female participants) the first day of your last period. The questionnaire will not require you to disclose any specific personal details regarding medical or family history and will only require a general statement. After completion of the questionnaire, you will have your heart rate and blood pressure measured.
Experimental sessions: At each of the four experimental sessions, you will be given one of the following medications:
1) Placebo (a pill containing flour and gelatine, which looks like the study medications but which does not contain any active ingredients.)
2) Dextroamphetamine (15mg)
3) Methylphenidate (30mg)
4) Modafinil (200mg)

After taking a medication/placebo capsule there will be a 90 minute waiting period where you can fill out a small survey, and then read quietly. After the waiting period, you will be asked to solve a number of computerized puzzles and tests of memory and planning. The entire session will take approximatly 3 hours, or 180 minutes.

A medical doctor will be on call at all times during all sessions, and all sessions will be held at the Murdoch Children’s Research Institute within the Royal Children’s Hospital, Parkville.

How will my confidentiality be protected?

Any identifiable data which you provide will be stored in password-protected files, and will only be accessed by the researchers. The information you provide will be safeguarded subject to any legal requirements, and will be destroyed at least 5 years after final publication of results. Any publications or presentations resulting from this study will be based on de-identified data only.

What if I want to withdraw from the research?

Participation in this research is completely voluntary. You are free to withdraw at any time and to withdraw any unprocessed data previously supplied. This would have no effect on your relationship with any member of the Department of Finance at the University of Melbourne. It would not affect your grades, assessment or any treatment that you would otherwise be eligible for.

Where can I get further information?

If you have not understood any of this information, please contact us at bmm-lab@unimelb.edu.au. This research project has been approved by the Human Research Ethics Committee of The University of Melbourne. If you have any concerns or complaints about the conduct of this research project, which you do not wish to discuss with the research team, you should contact the Manager, Human Research Ethics, Research Ethics and Integrity, University of Melbourne, VIC 3010. Tel: +61 3 8344 2073 or Email: humanethics-complaints@unimelb.edu.au All complaints will be treated confidentially. In any correspondence please provide the name of the research team or the name or ethics ID number of the research project.

How Do I Agree to Participate?

Please note that if you have previously taken part in our “complexity in problem solving” (also called “complexity and the brain”) experiment (HREC 1749616.3), you cannot sign up for this experiment.  Feel free to email bmm-lab@unimelb.edu.au if you are unsure.

If you decide to participate, please sign up for a preliminary screening session here.

Human ethics approval

This study has been approved by the University of Melbourne Human Research Ethics Committee (project ID: HREC: 1749142.1). It has also been registered with the Australian Therapeutic Goods Administration Clinical Trials Notification service (CT-2017-CTN-04278-1 v1), and the Australia and New Zealand Clinical Trials registry (ACTRN12617001544369).

Brain, Mind and Markets Lab
Department of Finance
The University of Melbourne
Victoria 3010
Australia
Phone: +61 3 9035 9950