Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000764437p
Ethics application status
Submitted, not yet approved
Date submitted
12/06/2025
Date registered
18/07/2025
Date last updated
18/07/2025
Date data sharing statement initially provided
18/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Dexamphetamine Help with Weight Loss? A Study in Primary Care
Scientific title
A double blinded randomised controlled trial to compare the efficacy of dexamphetamine versus placebo on weight loss for adults with obesity
Secondary ID [1] 314639 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a follow up study to ACTRN12614000654651.

Health condition
Health condition(s) or problem(s) studied:
Obesity 337794 0
Condition category
Condition code
Diet and Nutrition 334138 334138 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331268 0
Treatment: Drugs
Comparator / control treatment
Placebo - glucose capsule
Control group
Placebo

Outcomes
Primary outcome [1] 341792 0
Change in weight
Timepoint [1] 341792 0
Baseline and end of treatment (6 months) and further follow up at 24 months after treatment ended
Secondary outcome [1] 448705 0
Depression
Timepoint [1] 448705 0
baseline and end of treatment (6 months)
Secondary outcome [2] 448704 0
Cardiac function
Timepoint [2] 448704 0
baseline and end of treatment (6 months)
Secondary outcome [3] 449742 0
Heart rate
Timepoint [3] 449742 0
Weekly for first 6 weeks, then monthly during treatment period and then at 3, 6, 12, 18 and 24 months post treatment cessation
Secondary outcome [4] 449746 0
Blood pressure
Timepoint [4] 449746 0
Weekly for first 6 weeks, then monthly during treatment period and then at 3, 6, 12, 18 and 24 months post treatment cessation

Eligibility
Key inclusion criteria
a) Adults aged 18-70 years
b) BMI 25-70
c) Medically stable
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319202 0
Self funded/Unfunded
Name [1] 319202 0
Country [1] 319202 0
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Country
Australia
Secondary sponsor category [1] 321669 0
None
Name [1] 321669 0
Address [1] 321669 0
Country [1] 321669 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317782 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 317782 0
Ethics committee country [1] 317782 0
Australia
Date submitted for ethics approval [1] 317782 0
09/07/2025
Approval date [1] 317782 0
Ethics approval number [1] 317782 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142134 0
Mr Alison Poulton
Address 142134 0
Nepean Clinical School, 62 Derby St, Kingswood NSW 2747
Country 142134 0
Australia
Phone 142134 0
+61 414281284
Fax 142134 0
Email 142134 0
[email protected]
Contact person for public queries
Name 142135 0
Natalie Gauci
Address 142135 0
Nepean Lung and Sleep, 28 Derby St, Kinsgwood NSW 2747
Country 142135 0
Australia
Phone 142135 0
+61 247223001
Fax 142135 0
Email 142135 0
[email protected]
Contact person for scientific queries
Name 142136 0
Natalie Gauci
Address 142136 0
Nepean Lung and Sleep, 28 Derby St, Kinsgwood NSW 2747
Country 142136 0
Australia
Phone 142136 0
+61 247223001
Fax 142136 0
Email 142136 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.