None listed
Conditions
Brief summary
Obesity is a major health problem which is becoming increasingly costly to individuals and society. It is a major risk factor for diabetes, cardiovascular and liver disease, sleep apnoea, some cancers and osteoarthritis. Despite obesity research being a priority area, current prevention is having little impact at a population level as obesity rates are increasing and treatment programs are generally seen as ineffective because there is little weight lost, or there is weight regain. Pharmacotherapy to reduce hunger improves weight loss, particularly when combined with lifestyle intervention. This study involves using dexamphetamine (DEX), an old drug that is cheap and has been shown to be effective for losing weight. The dose will be 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). Its complications are already known and are almost exclusively dose dependent. DEX 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 DEX is safe and more effective than placebo for treating obesity complicated by obstructive sleep apnoea over a six month period and b) whether weight loss can be sustained for 2 years after ceasing the study drug.
Interventions
6 months treatment with dexamphetamine 5mg oral tablets given twice daily. The dose is increased by weekly increments of 10mg to a maximum of 12 tablets per day (60mg), stopping short of the maximum dose if there are side effects.
Sponsors
Nepean Blue Mountains LHD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adults aged 18-70, BMI 25-60, AHI (apnoea-hypopnoea index) of at least 15.
Exclusion criteria
History of addiction to illicit drugs, uncontrolled hypertension >140/90, symptomatic ischaemic heart disease, significant kidney or liver disease, uncontrolled epilepsy, breastfeeding, pregnant or planning pregnancy, history of bariatric surgery, current depression or other psychiatric illness, agitated states, anxiety, motor tics, Tourette syndrome, use of some medications, current or recent treatment (past 12 months) with psychotropic medication, uncontrolled endocrine disorder, glaucoma, previous severe drug reactions, significant cardiac arrhythmia, systemic glucocorticoids or medication for weight loss (eg orlistat), family history of sudden death from cardiac causes, hypersensitivity to DEX or any components of the DEX or placebo tablet.
Outcome results
None listed