A pilot study to investigate the efficacy of dexamphetamine to treat obesity using dosage titration

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000831886

Enrollment

Registered

2012-08-07

Start date

2012-06-20

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The project is designed to test a) whether dexamphetamine can be used safely to treat adults with obesity, b) whether dexamphetamine is effective for treating obesity over a six month period

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

BMI > 30

Exclusion criteria

Unstable heart disease Uncontrolled hypertension History of addiction to illicit drugs uncontrolled epilepsy weight change of +/- 3kg the past 3 months breastfeeding, pregnant or planning pregnancy current depression or other psychiatric illness current or recent treatment (past 12 months) with psychotropic medication, systemic glucocorticoids or medication for weight loss (eg orlistat) family history of sudden death from cardiac causes

Outcome results