Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000654651
Ethics application status
Approved
Date submitted
10/06/2014
Date registered
23/06/2014
Date last updated
23/06/2024
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial to investigate the efficacy of dexamphetamine compared to placebo for treating obesity complicated by obstructive sleep apnoea
Scientific title
Effect of dexamphetamine versus a placebo on body weight, apnoea-hypopnoea index (AHI) and changes in prescribed medications in obese adults with obstructive sleep apnoea
Secondary ID [1] 284766 0
nil
Universal Trial Number (UTN)
U1111-1157-8317
Trial acronym
Dex-OSA-RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 292137 0
Obstructive sleep apnoea 292138 0
Condition category
Condition code
Diet and Nutrition 292472 292472 0 0
Obesity
Respiratory 292473 292473 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289561 0
Treatment: Drugs
Comparator / control treatment
6 months of treatment with placebo tablets
Control group
Placebo

Outcomes
Primary outcome [1] 292337 0
Change in body weight from baseline as measured using digital scales
Timepoint [1] 292337 0
6 months, 2 years
Primary outcome [2] 292338 0
Change in AHI (apnoea-hypopnoea index) from baseline using polysomnography
Timepoint [2] 292338 0
6 months
Primary outcome [3] 292339 0
Changes in prescribed medication: the study participants will be asked to list the prescribed medications and doses that they are taking at baseline and at 6 months.
Timepoint [3] 292339 0
6 months
Secondary outcome [1] 308729 0
Changes in blood pressure as measuredon an aneroid sphygmomanometer.
Timepoint [1] 308729 0
3 months and 6 months
Secondary outcome [2] 308730 0
Changes in fasting lipids, insulin, glucose and HbA1c using serum assay
Timepoint [2] 308730 0
6 months
Secondary outcome [3] 308732 0
ECG changes - changes in heart rate, any ECG abnormality, eg cardiac arrhythmia
Timepoint [3] 308732 0
3 months

Eligibility
Key inclusion criteria
Adults aged 18-70, BMI 25-60, AHI (apnoea-hypopnoea index) of at least 15.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation determined from a list held by the pharmacy, treatment dispensed as identical tablets and containers labelled 'dexamphetamine or placebo'
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised 1:1, order determined by dice rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
6 months treatment only. 6 months is end point
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2014
Actual
12/06/2015
Date of last participant enrolment
Anticipated
29/11/2024
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
60
Accrual to date
57
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2612 0
Nepean Hospital - Kingswood

Funding & Sponsors
Funding source category [1] 289383 0
Hospital
Name [1] 289383 0
Nepean Hospital Department of Cardiology Trust Fund
Country [1] 289383 0
Australia
Primary sponsor type
Hospital
Name
Nepean Blue Mountains LHD
Address
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 288070 0
None
Name [1] 288070 0
nil
Address [1] 288070 0
na
Country [1] 288070 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291147 0
Nepean Blue Mountains HREC
Ethics committee address [1] 291147 0
Nepean Hospital
PO Box 63
Penrith NSW 2751
Ethics committee country [1] 291147 0
Australia
Date submitted for ethics approval [1] 291147 0
Approval date [1] 291147 0
14/05/2014
Ethics approval number [1] 291147 0
14/12 - HREC/14/NEPEAN/25

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49094 0
Dr Alison Poulton
Address 49094 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 49094 0
Australia
Phone 49094 0
+61 247343363
Fax 49094 0
Email 49094 0
[email protected]
Contact person for public queries
Name 49095 0
Dr Alison Poulton
Address 49095 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 49095 0
Australia
Phone 49095 0
+61 247343363
Fax 49095 0
Email 49095 0
[email protected]
Contact person for scientific queries
Name 49096 0
Dr Alison Poulton
Address 49096 0
Nepean Hospital
PO Box 63
Penrith
NSW 2751
Country 49096 0
Australia
Phone 49096 0
+61 247343363
Fax 49096 0
Email 49096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been part of the study design or ethics approval


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.