None listed
Conditions
Brief summary
Obesity is a growing health issue, and current treatments are often expensive or not widely available. This study is testing whether dexamphetamine, an older and affordable medication, can safely and effectively help people lose weight when combined with diet and lifestyle changes. Participants in the study will either receive dexamphetamine or a lookalike placebo for six months, with regular check-ins to monitor health and support lifestyle habits. The medication dose will be carefully adjusted based on individual response and safety, and participants will be followed for two years after treatment ends. If successful, this research could lead to a more accessible and cost-effective way to manage obesity in everyday healthcare settings.
Interventions
Dexamphetamine will be administered orally at a starting dose of 5 mg twice daily, with weekly titration over a six-week period to a maximum dose of 60 mg twice daily, based on adverse events and individual tolerance. The medication will be prescribed in tablet form, and any unused tablets will be returned. The general practitioner (GP) will be responsible for reviewing dosing and overseeing the titration process. Participants will be monitored at 3 months post-treatment, and subsequently at 6,
Dexamphetamine will be administered orally at a starting dose of 5 mg twice daily, with weekly titration over a six-week period to a maximum dose of 60 mg twice daily, based on adverse events and individual tolerance. The medication will be prescribed in tablet form, and any unused tablets will be returned. The general practitioner (GP) will be responsible for reviewing dosing and overseeing the titration process. Participants will be monitored at 3 months post-treatment, and subsequently at 6, 12, 18, and 24 months post-treatment, through in-person clinic visits conducted by the GP.
Sponsors
Nepean Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
a) Adults aged 18-70 years b) BMI 25-70 c) Medically stable
Exclusion criteria
a) Significant cardiac valve disease, cardiomyopathy, or arrhythmia b) Symptomatic ischemic heart disease c) History of addiction to illicit drugs d) Uncontrolled hypertension >140/90 e) Significant kidney or liver disease f) Uncontrolled epilepsy g) Breastfeeding, pregnant, or planning pregnancy i) Current depression or other psychiatric illness j) Current or recent treatment (past 12 months) with psychotropic medication, systemic glucocorticoids, or weight loss medication (e.g., orlistat, phentermine) k) Family history of sudden death from cardiac causes l) Hypersensitivity to DEX or any components of the DEX or placebo tablet
Outcome results
None listed