A study to investigate the efficacy of dexamphetamine compared to placebo for treating obesity complicated by obstructive sleep apnoea

Summary

The project represents a new approach to the pharmacological treatment of obesity. It uses dexamphetamine but unlike most drug trials using appetite suppressants, the focus is on the psychotropic effects of enhancing motivation for establishing the necessary lifestyle changes. The long-term aim is to develop a cost-effective treatment program that can be used as early intervention for obesity.

The study is currently recruiting, with most of the medical reviews being carried out by Dr Poulton. Involvement of an enthusiastic Masters or PhD student would enable recruitment to be completed within 1 year

Supervisor(s)

Dr Alison Poulton

Research Location

Nepean - Nepean Clinical School

Program Type

Masters/PHD

Synopsis

This study involves using dexamphetamine, an old drug that is cheap and has been shown to be effective for losing weight. The dose is titrated in a way that is highly innovative in terms of the treatment of obesity but is supported by decades of experience in the treatment of attention deficit hyperactivity disorder (ADHD). The complications of dexamphetamine are already known and are almost exclusively dose dependent. Dexamphetamine has the potential to provide a cheap and effective alternative to the currently available expensive anorexigenic medications and surgical treatment.

The project is designed to test
a) whether dexamphetamine is safe and more effective than placebo for treating obesity over a six month period
b) whether weight loss can be sustained for 6 months after ceasing the study drug.

Design: double blind randomised controlled trial of 6 months on treatment with 60 participants with obstructive sleep apnoea (apnoea/hypopnoea index (AHI) at least 15, BMI 30-60, age 18-65) randomised 1:1 to dexamphetamine or placebo. The dose is increased as tolerated to 30mg (6 tablets) twice daily. All participants receive dietary and exercise advice. Weight and blood pressure are monitored during treatment and for 2 years after ceasing treatment. Fasting blood tests for electrolytes, creatinine, lipids, insulin and liver and thyroid function are taken at baseline and at the end of treatment. All participants have baseline cardiac investigations, with the ECG repeated once the full dose is reached and the cardiac ultrasound repeated at the end of treatment.

The psychotropic effects of dexamphetamine are monitored using a 5-10 minute computer based test (the Stop Signal Task) and a rating scale of executive functioning. Amphetamine effects are monitored using the Amphetamine Interview Rating Scale, which is administered with every dose change.

Primary outcomes: percentages in each group achieving 5 and 10% weight loss from baseline after the 6 months of treatment and after the following 2 years; changes in AHI.

Additional Information

The study is being carried out by the following investigators:
Dr Alison Poulton, Nepean Hospital
Dr David Coulshed, Nepean Hospital
Dr Bernard Champion, Nepean Hospital
A/Prof Emily Hibbert, Nepean Hospital
Dr Donald Lee, Sleep Physician
Ms Brooke Fallon, sleep scientist
Ms Kaye Foster-Powell, Nepean Hospital
Prof David Alais, School of Psychology, University of Sydney

Dr Poulton is the primary supervisor, but another member of the research team could also be involved as a secondary supervisor.

Benefits to the successful candidate
• As part of The Nepean Clinical School and the Charles Perkins Centre Nepean you will be part of an innovative multidisciplinary research team working on an exciting new approach to treating obesity. The local population and medical clinics provide ample opportunity for recruitment of participants for research.
• You will be mentored for submission of a competitive application for an Australian Postgraduate Award or a University Postgraduate Award (APA/UPA, for domestic students). Further details
• Opportunity for a Top-Up Scholarship for APA or UPA-funded students of high standing, with the possibility of Top-Up Scholarship extension for students who are productive in publishing their research on this topic
• You will receive mentoring to help you develop your career, with individual and group training on scientific writing, conference presentation skills etc
• You will have opportunities to present your research findings at local, national and potentially also at an international biomedical conference
• You will have opportunities to publish your research findings in world-class peer-reviewed biomedical journals of high standing

Selection criteria
• An undergraduate degree in science, medicine or other health discipline (e.g. exercise physiology, nutrition & dietetics, nursing, pharmacy, physiotherapy, psychology, biochemistry, physiology etc.)
• First class honours or equivalent (for PhD candidates)
• An excellent undergraduate academic record (for Masters and PhD candidates)
• Prospective PhD candidates must be eligible for a nationally competitive PhD scholarship, such as an Australian Postgraduate Award or a University Postgraduate Award (APA/UPA, for domestic students) or an equivalent award for international students. Further details.
• A strong commitment to health and medical research in the field of adult nutrition and lifestyle interventions, obesity, weight management and chronic disease prevention
• Exceptional communication skills that will enable you to engender support from participants volunteering for this randomised controlled trial
• Ability to work productively both within a team environment as well as independently as required
• Excellent organisational skills
• Reliability and punctuality

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Keywords

Obesity, dexamphetamine, obstructive sleep apnoea, Randomised Controlled Trial

Opportunity ID

The opportunity ID for this research opportunity is: 1023

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